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Oncology

sentinel lymph node localisation in breast cancer

British Journal of Surgery (2017): Karakatsanis et al.: Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer
Core message: This study in 338 breast cancer patients showed that the use of SPIO is easy and can be performed by the surgeon alone. Detection rates in Sentinel Lymph Node Biopsy are comparable to the dual technique.

Breast Cancer Research and Treatment (2016): Karakatsanis A. et al. The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc99 and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies
Core message: “SPIO is an effective method for the detection of SN in patients with breast cancer. It is comparable to the standard technique and seems to simplify logistics.”

Annals of Surgical Oncology (2016): Teshome M. et al. Use of a Magnetic Tracer for Sentinel Lymph Node Detection in Early-Stage Breast Cancer Patients: A Meta-analysis
Core message: Sentinel Lymph node detection with Sienna+® revealed non-inferior performance to the standard method in breast cancer patients with clinically node-negative status.

Journal of Surgical Oncology (2015): Houpeau J.L. et al. Sentinel lymph node identification using superparamagnetic iron oxide particles versus radioisotope: The French Sentimag feasibility trial
Core message: Sentinel lymph node detection with Sienna+ is seen as a feasible method and a promising alternative to radiotracer. A beneficial potential was identified for ambulatory surgery or sites without nuclear medicine departments.

European Journal of Cancer Care (2015): Ghilli M. et al. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment
Core message: Sentimag® was identified as safe with non-inferior performance compared to the radiotracer. The Sentimag® technique can be applied after a minimum learning curve. Especially when nuclear medicine units are not available, the magnetic detection provides an effective treatment of breast cancer patients.

European Journal of Surgical Oncology (2015): Piñero-Madrona et al. The superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study
Core message: This study showed non-inferiority of the Sentimag technique compared to radiotracer. Ex-vivo and intraoperative detection rates at the node level were found to be slightly higher with Sentimag.

European Journal of Surgical Oncology (2014): Rubio I.T. et al. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer
Core message: Detection of SLNs with SPIO was not inferior to radiotracer. Procedure is safe, reliable and facilitates patients and OR management.

The Breast (2014): Thill M. et al.: The Central-European SentiMag study Sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope
Core message: “We obtained convincing results that magnetic SLNB can be performed easily, safely and equivalently well in comparison to the radiotracer method.”

Annals of Surgical Oncology (2013): Douek M. et al. Sentinel Node Biopsy Using a Magnetic Tracer Versus Standard Technique: The SentiMAG Multicentre Trial
Core message: Sentimag/Sienna+ is a feasible technique for SLNB. The identification rate is not inferior to the standard.

 

Sentinel lymph node analysis in breast cancer

Molecular and Clinical Oncology (2017): Fung V. et al. Intraoperative prediction of the two axillary lymph node macrometastases threshold in patients with breast cancer using a one-step nucleic acid cytokeratin-19 amplification assay
Core message: “OSNA identifies a TTL threshold value where, in the presence of involved SLNs, ALND may be avoided. This technique offers objective confidence in adopting conservative management of the axilla in patients with SLN macrometastases.”

The Breast (2017): Peg V. et al. Role of total tumour load of sentinel lymph node on survival in early breast cancer patients
Core message: “SLN TTL permits the differentiation between two patient groups in terms of DFS and OS, independently of axillary staging (pN), age and tumour characteristics (size, grade, lymphovascular invasion). This new data confirms the clinical value of low axillary involvement and could partially replace the information that staging of the entire axilla provides in patients on whom no axillary lymph node dissection is performed.”

PLoS One  (2017): Terrenato I. et al. A cut-off of 2150 cytokeratin 19 mRNA copy number in sentinel lymph node may be a powerful predictor of non-sentinel lymph node status in breast cancer patients
Core message: “Logistic regression models indicated that the cut-off of 2150 copies better discriminates patients with node negative or positive in comparison with the conventional OSNA cut-off (p<0.0001). This cut-off identifies false positive and false negative cases and true-positive and true negative cases very efficiently, and therefore better identifies which patients really need an ALND and which patients can avoid one. This is why we suggest that the negative cut-off should be raised from 250 to 2150. Furthermore, we propose that for patients with a copy number that ranges between 2150 and 5000, there should be a multidisciplinary discussion concerning the clinical and bio-morphological features of primary breast cancer before any decision is taken on whether to perform an ALND or not.”

Journal of Experimental & Clinical Cancer Research (2016): Di Filippo F et al. Elaboration of a nomogram to predict nonsentinel node status in breast cancer patients with positive sentinel node, intraoperatively assessed with one step nucleic amplification: Retrospective and validation phase
Core message: ”The results of the study confirm that OSNA nomogram may help surgeons make an intraoperative decision on whether to perform ALND or not in case of positive sentinel nodes, and the patient to accept this decision based on a reliable estimation on the true percentage of NSN involvement. The use of this nomogram achieves two main gools: 1) the choice of the right treatment during the operation, 2) to avoid for the patient a second surgery procedure.”

Molecular and Clinical Oncology (2016): Parada D. et al. Intraoperative molecular analysis of sentinel lymph nodes following neoadjuvant chemotherapy in patients with clinical node negative breast cancer: An institutional study
Core message: “The OSNA assay is a highly sensitive, specific and reproducible diagnostic technique that can be used to analyse SLNs following NAC. The total tumoral load may assist with predicting additional non SLN metastases.”

The Breast (2016): Espinosa-Bravo M. et al. Intraoperative assessment of sentinel lymph node by one-step nucleic acid amplification in breast cancer patients after neoadjuvant treatment reduces the need for a second surgery for axillary lymph node dissection
Core message: The accurate and standardized intraoperative SLN analysis by OSNA decreases the need of a second surgery in 18.5% of breast cancer patients with a positive SLN after neoadjuvant therapy.

Surgery Today (2016): Shimazu K. et al. Clinical significance of breast cancer micrometastasis in the sentinel lymph node
Core message: The OSNA method shows the benefit of reproducibility among different institutions and the capability of analysing a whole lymph node in only 30-40 minutes.

Molecular and Clinical Oncology (2016): Kubota M et al. One-step nucleic acid amplification assay for intraoperative prediction of advanced axillary lymph node metastases in breast cancer patients with sentinel lymph node metastasis
Core message: The Total Tumour Load (TTL) determined by OSNA analysis can predict further axillary lymph node metastases in breast cancer patients. The TTL can be assessed intra-operatively, thus it can be used during surgery to determine the need for axillary lymph node dissection.

European Journal of Surgical Oncology (2016): Banerjee SM et al. The use of one-step nucleic acid amplification (OSNA) and tumour related factors in the treatment of axillary breast cancer: A predictive model
Core message: A predictive model combining Total Tumour Load (TTL) determined by OSNA analysis with lymphovascular invasion can identify breast cancer patients who require additional axillary treatment, i.e. axillary lymph node dissection or other adjuvant measures.

Histopathology (2016): Vieites B. et al. CK19 expression in breast tumours and lymph node metastasis after neoadjuvant therapy
Core message: The expression of CK19 protein is preserved after neoadjuvant therapy. This indicates that OSNA is a suited approach for lymph node analysis also upon neoadjuvant treatment.

Revista de Senología y Patología Mamaria (2015): Bernet L. et al. A multiparametric predictive model of axillary status in patients with breast cancer: total tumoral load and molecular signature. A multicenter study
Core message: “The inclusion of PM in the multivariate model improved the AUC, especially when the total number of sentinel nodes were included. Differences were observed in the impact of the CTT among the different molecular profiles subtypes.”

Journal of Experimental & Clinical Cancer Research (2015): Di Filippo F. et al. Elaboration of a nomogram to predict non sentinel node status in breast cancer patients with positive sentinel node, intra-operatively assessed with one step nucleic acid amplification method
Core message: The nomogram described by Di Filippo et al. is a very useful tool for predicting non-SLN status in breast cancer patients with positive SLNs assessed intra-operatively by OSNA.

The Breast (2014): Piñero-Madrona A. et al. Tumoral load quantification of positive sentinel lymph nodes in breast cancer to predict more than two involved nodes
Core message: In this study, the OSNA result clearly correlates with the risk of having two or more metastatic non-SLNs in breast cancer patients.

Breast Cancer Research and Treatment (2014): Rubio IT. et al. Nomogram including the total tumoral load in the sentinel nodes assessed by one-step nucleic acid amplification as a new factor for predicting nonsentinel lymph node metastasis in breast cancer patients
Core message: The nomogram described by Rubio et al. incorporates the Total Tumour Load (TTL) assessed by OSNA and can be used to predict non-SLN positivity. This useful tool can support clinicians in decision-making.

Journal of Clinical Pathology (2014): Deambrogio C. et al. A new clinical cut-off of cytokeratin 19 mRNA copy number in sentinel lymph node better identifies eligible for axillary lymph node dissection in breast cancer
Core message: The CK19 mRNA copy number represents a useful tool to predict the probability of nodal involvement and thus, it can be applied for the selection of patients in which axillary lymph node dissection could be recommended due to the high risk of further axillary lymph node metastases.

Annals of Oncology (2013): Klingler S. et al. Using one-step nucleic acid amplification (OSNA) for intraoperative detection of lymph node metastasis in breast cancer patients avoids second surgery and accelerates initiation of adjuvant therapy
Core message: The intraoperative SLN analysis by OSNA reduces the need of a second surgery in breast cancer patients and allows a prompt initiation of adjuvant therapy.

European Journal of Surgical Oncology (2013): Espinosa-Bravo M. et al. Prediction of non-sentinel lymph node metastasis in early breast cancer by assessing total tumoral load in the sentinel lymph node by molecular assay
Core message: Intraoperatively assessed Total Tumour load (TTL) in SLNs of clinically node negative breast cancer patients predicts for further non-SLN metastasis. TTL helps decision-making on performing or not axillary lymph node dissection.

European Journal of Cancer (2013): Osako T. et al. Sentinel node tumour burden quantified based on cytokeratin 19 mRNA copy number predicts non-sentinel node metastases in breast cancer: molecular whole-node analysis of all removed nodes
Core message: The CK19 mRNA copy number determined by OSNA predicts non-SLN metastases. This study further support the predictive value of the OSNA result.

British Journal of Cancer (2013): Osako T et al. Molecular detection of lymph node metastasis in breast cancer patients treated with preoperative systemic chemotherapy: a prospective multicentre trial using the one-step nucleic acid amplification assay
Core message: “The OSNA assay can detect the residual tumour burden as accurately as conventional pathology, although chemotherapy-induced histological changes are present.”

European Journal of Surgical Oncology (2013): Navarro-Cecilia J. et al. Intraoperative sentinel node biopsy by one-step nucleic acid amplification (OSNA) avoids axillary lymphadenectomy in women with breast cancer treated with neoadjuvant chemotherapy
Core message: The OSNA result can predict the axillary status with a high accuracy also in clinically node negative patients at initial presentation who underwent neoadjuvant therapy.

Breast Cancer Research and Treatment (2013): Peg V. et al. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients
Core message: The Total Tumour Load (TTL) determined by OSNA is an independent predictor of the nodal status and can support clinicians in personalising surgical treatment.

Journal of Breast Cancer (2013): Sagara Y. et al. Clinical application of the one-step nucleic acid amplification method to detect sentinel lymph node metastasis in breast cancer
Core message: The OSNA assay allows the accurate analysis of SLN and the prediction of non-SLN metastases. Moreover, applying this technique reduces pathologist’s workload.

Journal of Cancer Research and Clinical Oncology (2013): Helimann T. et al.: Intra-operative use of one-step nucleic acid amplification (OSNA) for detection of the tumor load of sentinel lymph nodes in breast cancer patients
Core message: OSNA is a very useful tool for supporting intra-operative decision-making about further axillary surgery, thus reducing the risk of second surgeries. Moreover, the CK19 copy number allows the prediction of further lymph node involvement and might help to find adequate adjuvant treatment options.

British Journal of Cancer (2012): Ohi Y. et al. Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer
Core message: The CK19 mRNA copy number in the SLN is the most significant predictor of non-SLN involvement.

International Journal of Cancer (2012): Le Frère-Belda MA. et al. Diagnostic performance of one-step nucleic acid amplification for intraoperative sentinel node metastasis detection in breast cancer patients
Core message: The OSNA method shows a higher sensitivity than intraoperative histological evaluation, and thus its use possibly leads to a decrease of the number of women who require a second surgical procedure for axillary lymph node dissection.

Journal of Clinical Pathology (2012): Cserni G. Intraoperative analysis of sentinel lymph nodes in breast cancer by one-step nucleic acid amplification
Core message: Cserni et al. describes in this review current literature and concerns related to the OSNA method.

Annals of Surgery (2012): Castellano I. et al. Reliability of whole sentinel lymph node analysis by one-step nucleic acid amplification for intraoperative diagnosis of breast cancer metastases
Core message: Whole SLN analysis by OSNA provides objective and reproducible results that help treatment decision making and accurate characterisation of SLN staging.

Journal of Breast Cancer Research and Treatment (2012): Godey F. et al. Sentinel lymph node analysis in breast cancer: contribution of one-step nucleic acid amplification (OSNA)
Core message: The intraoperative analysis of SLN by OSNA enables the surgeon to perform, when necessary, axillary lymph node dissection during the same procedure.

Histopathology (2011): Bernet L. et al. Diagnosis of the sentinel lymph node in breast cancer: a reproducible molecular method: a multicentric Spanish study
Core message: OSNA is a very sensitive, specific and reproducible method that enables standardisation of the SLN diagnostic procedure.

British Journal of Surgery (2011): Snook KL. et al. http://onlinelibrary.wiley.com/doi/10.1002/bjs.7347/abstractMulticentre evaluation of intraoperative molecular analysis of sentinel lymph nodes in breast carcinoma
Core message: OSNA allows accurate intraoperative evaluation of SLN and show excellent concordance with histology. This promising approach will become the standard method for analysis of SLN and axillary LNs.

Virchows Archiv (2009): Schem C. et al. One-step nucleic acid amplification – a molecular method for the detection of lymph node metastases in breast cancer patients; results of the German study group
Core message: OSNA is a reliable and standardized tool for the intraoperative detection of lymph node metastases and its adoption may lead to a benefit for the patients since unnecessary second surgeries are avoided.

International Journal of Cancer (2008): Visser M. et al. Intra-operative rapid diagnostic method based on CK19 mRNA expression for the detection of lymph node metastases in breast cancer
Core message: OSNA enables whole lymph node analysis and therefore, sampling errors, which are related to histological techniques, are avoided. Moreover, the automated procedure leads to a high degree of standardization and objectivity.

Clinical Cancer Research (2007): Tsujimoto M. et al. One-step nucleic acid amplification for intraoperative detection of lymph node metastasis in breast cancer patients
Core message: CK19 mRNA copy number cut-off values enable to distinguish among macrometastasis, micrometastasis, and non-metastasis. The clinical findings indicate that the OSNA assay is a useful intraoperative detection method for the detection of lymph node metastasis in breast cancer patients.

Faecal immunochemical test for colorectal cancer screening

Lancet Gastroenterol Hepatol (2019): De Klerk C.M. et al. Performance of two faecal immunochemical tests for the detection of advanced neoplasia at different positivity thresholds: a cross-sectional study of the Dutch national colorectal cancer screening programme
Core message: The goal of this study was to compare the Hb concentration distributions and positivity rates of FOB Gold and OC Sensor at different positivity cut-offs. Despite the Hb concentrations and dedicated positivity rates per cut-off measured with both assays out of the same stool sample varied, their power to detect advanced neoplasia (confirmed by colonoscopy) was similar when compared at the same positivity rate. Both FOB Gold and OC Sensor demonstrate an equal accuracy if the cut-off for positivity is standardized to result in the same positivity rate.

Gastroenterology (2018): Wieten E. et al. Equal Accuracy of 2 Quantitative Fecal Immunochemical Tests in Detecting Advanced Neoplasia in an Organized Colorectal Cancer Screening Program
Core message: More than 21,000 randomly selected participants of the Dutch CRC screening programme completed the FOB Gold and OC Sensor FIT derived from the same stool sample. During this prospective study no significant differences in the power of the diagnostic performance of FOB Gold and OC-Sensor were detected in regards to the detection of advanced neoplasia.

Clinical Epidemiology (2018): Brenner H. et al. Variation of diagnostic performance of fecal immunochemical testing for hemoglobin by sex and age: results from a large screening cohort
Core message: In real screening settings (n=3211, age of 50 to 79) the diagnostic performance of FOB Gold was evaluated based on age and sex over a range of cut-offs. A higher sensitivity for the 65 to 79 age group compared to the 50 to 64 age group could be observed as well as a lower sensitivity and higher specificity for women versus men. PPVs and NPVs did not show significant differences between age groups, but higher NPVs were detected among women compared with men. These differences in diagnostic performance based on sex and age should be factored in for interpretation and comparison of FIT-based CRC screening studies.

Int J Cancer (2017): Gies A. et al. Quantitative Fecal Immunochemical Tests for Colorectal Cancer Screening
Core message: A meta-analysis revealed 22 studies with 7 quantitative FITs (inclusive FOB Gold) that evaluated their diagnostic performance at several cut-off points. In these studies, colonoscopy was conducted independently from the FIT result. Heterogeneity in diagnostic performance (sensitivity, specificity) between the FITs can be completely overcome by appropriate cut-off adjustments. The authors recommended that screening programmes should adjust the FIT cut-off corresponding to a yielded positivity rate as a good indicator for the specificity, and based on a feasible colonoscopy workload.

Clinical Chemistry and Laboratory Medicine (2017): Augé J.M. et al. An Evaluation of the SENTiFIT 270 analyser for quantitation of faecal haemoglobin in the investigation of patients with suspected colorectal cancer
Core message: Performance of a technical and clinical evaluation on 487 symptomatic patients using SENTiFIT® 270. Outcome of the clinical evaluation: Hb levels from patients with advanced colorectal neoplasia (ACRN = CRC plus advanced adenoma) were significantly higher than from those with a normal colonoscopy examination. Sensitivity for ACRN at cut-offs from 10 to 60 μg Hb/g faeces ranged from 28.9% to 46.5%, specificity from 85.0% to 93.2%, PPV from 34.7% to 42.3% and NPV from 90.2% to 88.4%. Overall the performances of SENTiFIT® 270 makes it suitable for use in a clinical chemistry laboratory for the early detection of ACRN and as aid in diagnosis of symptomatic patients.

Clinical and Translational Gastroenterology (2017): Brenner H. et al. Selecting a Cut-off for Colorectal Cancer Screening With a Fecal Immunochemical Test
Core message: The diagnostic performance of FOBGold for detecting advanced neoplasms (AN) across a cut-off range of 5-50 µg Hb/g feces has been assessed in a true screening setting (50–79 years) in Germany. As example a cut-off defined as 17 µg Hb/g feces would yield to a 8.7% positivity rate, 35.7% sensitivity, 94.7% specificity and 46.5% PPV for detecting AN. Therefore selecting a cut-off according to the range of 5-50 µg Hb/g feces should reflect characteristics of the target population such as AN prevalence or available colonoscopy capacity (tailoring to the needs of the respective program).

Gaceta Sanitaria (2017): Solé Llop M.E. et al. Colorectal cancer screening programme in Aragon (Spain): preliminary results
Core message: Data were collected from the 1st year of the Aragon screening program (2014) based on FIT in patients 60-69 years old (participation rate: 45.28%). FOBGold is applied biannually with a cut-off of 20 µg/g feces (on SENTiFIT® 270). After the 1st year the positivity rate was 10.75% and the PPV for any adenoma/advanced adenoma/CRC 58.55%/14.36%/5.36%. The inadequate test rate has been judged as quite acceptable with 0.21%. The analysis of the ongoing program suggests the program is being correctly implemented.

National Institute for Public Health and the Environment (RIVM) (2016): Erasmus MC Rotterdam, NKI/Antoni van Leeuwenhoek COLORECTAL CANCER SCREENING PROGRAMME • Monitor 2014, 2015, 2016
Core message: RIVM commissioned Erasmus MC and the Netherlands Cancer Institute (NKI)/Antoni van Leeuwenhoek Hospital to carry out national monitoring of the CRC screening programme on an annual basis. Considering the first screening rounds in all 3 years participation rates (~71-73%) were quite similar. The same was valid for positivity and detection rates for advanced neoplasia (AN). During the second round in 2016 an increase in participation rate was visible and not unexpected, the positivity and detection rates and PPV decreased compared to the first round. This is based on the fact that the prevalence of AN normally decreases after the first rounds of screening. 

International Journal of Cancer (2017): Brenner H. et al. Strong subsite-specific variation in detecting advanced adenomas by fecal immunochemical testing for haemoglobin
Core message: FOB-Gold was applied prior to colonoscopy by 3.466 participants of the German screening colonoscopy program. The goal was to proof the subsite specific sensitivity for various types of colorectal neoplasms by comparing FIT results with findings at screening colonoscopy. The iFOBT FOB-Gold showed a sensitivity of 95-100% and therefore an excellent performance in detecting CRC.

Gastroenterology (2017): Toes-Zoutendijk E. et al. Real-Time Monitoring of Results During First Year of Dutch Colorectal Cancer Screening Program and Optimization by Altering Fecal Immunochemical Test Cut-Off Levels
Core message: Data were collected from the first year of the Dutch screening program (2014) with biennial FITs by real-time monitoring (529.056 people participating). Because of the higher than predicted positivity rate (10.6%) and the lower PPV (42.1%) after some months the FOB-Gold test cut-off was increased (from 15 to 47 µg Hb/g feces), resulting finally in 6.7% positivity rate and 49.1% PPV. It has been concluded that for optimization of screening performance (test cut-off adjustments) a close monitoring of the implementation program is needed.

European Journal of Cancer Prevention (2016): Dancourt V. et al. Influence of sample return time and ambient temperature on the performance of an immuno-chemical faecal occult blood test with a new buffer for colorectal cancer screening
Core message: Investigation on the effects of sample return time and of season on the FOB-Gold performance with a new buffer (study included 20.371 participants from French SP). The positivity rates were 4.1, 4.1 and 4.6% for a sample return time of up to 3 days, 4-5 days and 6-7 days. At 20°C there was a decrease in Hb concentration of 5.1% after 7 days, at 30°C of 20.5%. As result at 20°C after 7 days 100% of the samples of participants with CRC (4/4) and 97% of samples of participants with advanced adenomas (38/39) remained positive. It was concluded that a delay in sample return and season did not affect the diagnostic yield of FOB-Gold.

Gut (2016): Grobbee E.J. et al. A randomised comparison of two faecal immuno-chemical tests in population-based colorectal cancer screening
Core message: Comparison of two iFOBTs (FOB-Gold and OC-Sensor) on Dutch screening population (n=19.291; 60-74 years old). Both iFOBTs were equally acceptable to the participants. The test performance regarding detection of colorectal advanced neoplasia was comparable for both tests, as well as the positive predictive value. In conclusion, the OC-Sensor and FOB-Gold perform similar in population-based screening.

Clinical Gastroenterology and Hepatology (2016): Chen H. et al. Fresh vs Frozen Samples and Ambient temperature have Little Effect on Detection of Colorectal Cancer or Adenomas by a Fecal Immunochemical Test in a Colorectal Cancer Screening Cohort in Germany
Core message: Comparison of detection of CRCs and colorectal neoplasms by FOB-Gold using fresh samples vs frozen samples and assessment of the influence of seasonal variations (temperatures) on test performance. 3.466 FIT sample results from the German colonoscopy screening program were assessed. 12.8% of frozen stool samples and 8.7% of fresh stool samples had positive results by FIT. After adjusting the test cut-off to achieve the same %age of positive results, both sample cohorts showed similar levels of sensitivity and specificity for colorectal neoplasms. In addition no differences in detection of neoplasms during different seasons (different outdoor temperatures) were observed. It has been concluded that the use of fresh vs frozen samples only slightly affected positivity rates at the recommended test cut-off.

United European Gastroenterology Journal (2016): Dvir R. et al. SENTIFIT 270 SYSTEM CLINICAL PERFORMANCE EVALUATION COMPARED WITH OC SENSOR DIANA, FOR THE DETECTION OF HUMAN HAEMOGLOBIN AS FAECAL OCCULT BLOOD (FOB)
Core message: The study goal was to compare the clinical performances of SENTiFIT FOB-Gold (SENTiFIT270 system) with the OC-SENSOR DIANA system. A good concordance between the SENTiFIT and the DIANA assay was observed: SENTiFIT assay is a valid quantitative FIT.

IFCC WorldLab Istanbul (2014) Poster Presentation: Soliera A.R. et al. Automated Faecal Imunoassay Testing (FIT) for Hemoglobin on a new dedicated analyzer
Core message: The SENTiFIT® 270 system with SENTiFIT® pierceTube for the quantitative determination of faecal occult blood was subjected to a performance evaluation based on CLSI standards. All of the manufacturer's data with respect to the analytical performance, linearity, prozone effect and reagent and calibration stability could be confirmed with a high accuracy.

IFCC WorldLab Istanbul (2014) Poster Presentation: Correale M. et al. SENTiFIT® - FOB Gold® latex Fecal Immunoassay Test (FIT) evaluation on SENTiFIT® 270 analyzer
Core message: The SENTiFIT® 270 system with SENTiFIT® pierceTube for the immunochemical quantitative determination of faecal occult blood was subjected to a performance evaluation based on CLSI standards. All of the manufacturer's data with respect to the analytical performance, linearity, prozone effect and reagent and calibration stability could be confirmed with a high accuracy. The system is user friendly and easy to use. The new, pierceable sample tube improves the measurement accuracy, reduces the input and leads to a complete automation of the FIT.

Clin Chem Lab Med (2014): Gnatta E. et al. A new sampling device for faecal immuno-chemical testing: haemoglobin stability is still an open issue
Core message: Evaluation of the Hb stability in faeces collected with FOB-Gold Tube Screen and Tube NG that contain different buffers (buffer H, BH). 15 true positive samples were collected with both buffers, portioned and incubated at 4, 21 and 32°C for 10 days. Endpoint was the percentage of cumulative faecal Hb decrease (HbCD%). The results showed that no significant difference was visible between BH and BN in HbCD% at 4°C. At 21 and 32°C the HbCD% was lower in BH than in BN samples whereas no difference was found between samples stored in BH at 4 and 21°C.

AACC ANNUAL MEETING & CLINICAL LAB EXPO (Chicago) (2014): Anelli MC. et al. https://www.sentineldiagnostics.com/uk/scientific-area/publications/sentifit-fob-gold-latex-fecal-immunoassay-test-fit-evaluation-on-sentifit-270-analyzer-in-corelab-at-the-ausl-modena-nuovo-sagostino-estense-hospital-in-emilia-romagna-region.aspxSENTiFIT®-FOB Gold® latex Fecal Immunoassay Test (FIT) evaluation on SENTiFIT® 270 analyzer in CoreLab at the AUSL Modena Nuovo S.Agostino Estense hospital in Emilia Romagna Region
Core message: The aim of this study was to compare two quantitative FITs: SENTiFIT270 and OC-Sensor Diana. Both systems showed a high concordance (95.8%), sensitivity (100%) and specificity (95.2%).

European Journal of Cancer (2013): Hamza S. et al. Diagnostic yield of a one sample immunochemical test at different cut-off values in an organised screening programme for colorectal cancer
Core message: The objective target of this evaluation was to check the performance of the quantitative immunochemical test FOB-Gold and to propose a possible strategy for an organized screening programme. Result of this study: a one-sample strategy is preferred and with a recommended cut-off, the overall positivity rate would be manageable in EU countries.

European Journal of Cancer (2012): Faivre J. et al. http://www.ejcancer.com/article/S0959-8049(12)00348-6/pdfComparison between a guaiac and three immunochemical faecal occult blood tests in screening for colorectal cancer
Core message: The objective of this study was to evaluate a guaiac-based (G-) FOBT (Hemoccult-II) versus 3 immunochemical (I-)FOBTs (FOB-Gold, OC-Sensor, Magstream) within the French population-based organized screening programme. The study outcome reveals additional proof that I-FOBTs are superior to the selected G-FOBT whereas none of the 3 applied I-FOBTs pointed out any significant performance advantages towards the others.

Digestive and Liver Disease (2012): Faivre J. et al. Positivity rates and performances of immunochemical faecal occult blood tests at different cut-off levels within a colorectal cancer screening programme
Core message: The goal of this study was to investigate the following approaches: on the one hand a 2-sample strategy with at least one positive test and on the other hand a 1-sample strategy implying various cut-off values for one of the two I-FOBTs (FOB-Gold or OC-Sensor) performed in combination with a G-FOBT (Hemoccult-II). It turned out that using I-FOBTs, an acceptable strategy (for the French CRC screening programme) would be 2-day sampling with at least one positive test at a cut-off between 150-200 ng/mL (OC-Sensor) and 176-234 ng/mL (FOB-Gold).

Digital pathology

Diagnostic Pathology (2017): Fu et al. Evaluation of a confocal WSI scanner for FISH slide imaging and image analysis
Core message: A study on 14 FISH slides scanned with confocal and wide field microscopy on a 3D Histech Pannoramic Scanner System showed that confocal imaging provides sharper images. Confocal multi-layer scanning is supposed to be the future application tool for FISH imaging.

Cytometry Part A (2017): Paulik R et al. An Optimized Image Analysis Algorithm for Detecting Nuclear Signals in Digital Whole Slides for Histopathology
Core message: A new 3D Histech algorithm for image analysis optimized for whole slide quantification of nuclear immunostaining signals of ER, PR, and Ki-67 proteins in breast cancers was tested against two other open source applications. The new algorithm outcompeted the comparators for histopathological evaluation of breast cancer biomarkers in accurately detecting nuclear signals of predictive and prognostic biomarkers (ER, PR, Ki-67) as well as fluorescent DAPI labeled cell nuclei and higher processing speed.

Cytometry Part A (2017): Paulik R et al. An Optimized Image Analysis Algorithm for Detecting Nuclear Signals in Digital Whole Slides for Histopathology
Core message: A new 3D Histech algorithm for image analysis optimized for whole slide quantification of nuclear immunostaining signals of ER, PR, and Ki-67 proteins in breast cancers was tested against two other open source applications. The new algorithm outcompeted the comparators for histopathological evaluation of breast cancer biomarkers in accurately detecting nuclear signals of predictive and prognostic biomarkers (ER, PR, Ki-67) as well as fluorescent DAPI labeled cell nuclei and higher processing speed.

The Journal of Pathology: Clinical Research (2017): Nolte et al. Construction and analysis of tissue microarrays in the era of digital pathology: a pilot study targeting CDX1 and CDX2 in a colon cancer cohort of 612 patients
Core message: Several investigated parameters indicate that CDX2 performs more robustly than CDX1 in terms of applicability. Our projected results show that (1) ngTMA is highly accurate and leads to a low frequency of tissue core loss, (2) different types of tumour heterogeneity can be investigated using the combined ngTMA-DIA workflow and (3) low percentages of CDX1 and CDX2 positive cells are associated with more aggressive tumour biology and the influence of different staining intensities on patient selection is much lesser in CDX2 than in CDX1.

Annals of Surgery (2016): Goos J. et al. Glucose Transporter 1 (SLC2A1) and Vascular Endothelial Growth Factor A (VEGFA) Predict Survival After Resection of Colorectal Cancer Liver Metastasis
Core message: During this investigation Tissue microarrays (TMA) were produced by using colorectal cancer (CRC) liver metastasis and patient-matched primary CRC. TMA covers every step of the digital TMA workflow from sample designation/slide preparation from the donor block to the final evaluation of the TMA project using TMA software solutions.

Journal of Visualized Experiments (2014): Zlobec I. et al. A Next-generation Tissue Microarray (ngTMA) Protocol for Biomarker Studies
Core message: “Tissue microarrays (TMA) are produced by repeated transfer of small tissue cores from a ‘donor’ block into a ‘recipient’ block and then used for a variety of biomarker applications. In this study a procedure using next-generation Tissue Microarrays (ngTMA) is decribed. ngTMA uses a protocol based on TMA planning and design, digital pathology and automated tissue microarraying. Due to its precision, flexibility and speed, ngTMA is a powerful tool to further improve the quality of TMAs used in clinical and translational research.”

APMIS (2012): Nap M. et al. A travel report of the implementation of virtual whole slide images in routine surgical pathology
Core message: This study provides an extensive overview about virtual microscopy and its implementation in the daily routine.

Diagnostic Pathology (2012): Fónyad L. et al. Validation of diagnostic accuracy using digital slides in routine histopathology
Core message: “Digital microscopy: a study designed to evaluate the scanning properties and digital slide based diagnostic accuracy. The study results reveal that digital slide based histopathological diagnoses can be highly coherent with those using optical microscopy, that the competency of pathologists is a factor more important than the quality of digital slide and that poor digital slide quality do not endanger patient safety as these errors are recognizable by the pathologist and further actions for correction could be taken.”

Stud Health Technol Inform. (2012): Varga VS. et al. Automated high throughput whole slide imaging using area sensors, flash light illumination and solid state light engine
Core message: This article deals with the technical background and conclusion behind engineering decisions made during the development of 3DHISTECH's 3rd generation combined brightfield and fluorescent scanner. By applying the current camera technology and standard microscope optical components, a high throughput and high quality whole slide imaging is feasible which meets all demands for most of the routine diagnostic work.

Wiley Online Library (2012): Rossing HH. et al. Implementation of TMA and digitalization in routine diagnostics of breast pathology
Core message: This study demonstrates that in breast cancer routine diagnostics the application of Tissue microarrays (TMA) combined with digitalization of the stained multi-slides is more economical, less time consuming and therefore accompanied with a considerable cost reduction. In the daily diagnostics this tool also improves standardization of tumour profiling.

Liquid biopsy in colorectal cancer

British Journal of Cancer (2018): Garcia-Foncillas J. et al. Prospective multicenter real-world RAS mutation comparison between OncoBEAM-based liquid biopsy and tissue analysis in metastatic colorectal cancer
Core message: This study represents the first prospective RAS mutation performance comparison providing a final concordance of 92% between plasma and tissue samples using the OncoBEAM™ RAS CRC assay (236 mCRC patients). This outcome reveals that the plasma-based OncoBEAM™ RAS CRC assay is a reliable opportunity to detect RAS mutations in order to decide about the rationale of applying anti-EGFR therapy.

Oncotarget (2018): Garcia J. et al. Cross-platform comparison for the detection of RAS mutations in cfDNA (ddPCR Biorad detection assay, BEAMing assay, and NGS strategy)
Core message: This study compared the performance of the OncoBEAM™ RAS CRC IVD assay to ddPCR and NGS for the detection of KRAS/NRAS mutations in plasma from mCRC and NSCLC patients based of the analysis of paired blood and tissue samples. The OncoBEAM™ RAS CRC test revealed higher sensitivity than the two other technologies by testing cfDNA vs tissue analysis in mCRC and NSCLC samples (extended RAS panel) and enabled monitoring of somatic alterations in plasma-derived cfDNA.

Translational Oncology (2018): Klein-Scory S. et al. Significance of Liquid Biopsy for Monitoring and Therapy Decision of Colorectal Cancer
Core message: This study monitored three mCRC patients who initially were RAS WT and demonstrate that follow-up using OncoBEAM RAS testing in plasma provides information about the clonal redistribution after discontinuation of anti-EGFR as well as emerging RAS mutations leading to resistance during anti-EGFR administration. On top of this it has been observed that RAS mutations can even develop in the absence of anti-EGFR therapy pressure.

Annals of Oncology (2017): Garcia-Foncillas J. et al. Incorporating BEAMing technology as a liquid biopsy into clinical practice for the management of colorectal cancer patients: an expert taskforce review
Core message: BEAMing technology for the detection of mutated ctDNA in plasma based on international guideline-recommended expanded RAS testing offers the opportunity of rapid turnaround times, high sensitivity and standardization compared to conventional testing of tissue samples. The high degree of concordance between plasma OncoBEAM RAS testing versus standard tissue testing methods has been shown in several studies. BEAMing posseses the potential to replace tissue biopsy for the detection and monitoring of RAS mutations and enables precision and cost-effective CRC patient management by individualizing treatment plans.

Annals of Oncology (2017): Grasselli J. et al. Concordance of blood- and tumor-based detection of RAS mutations to guide anti-EGFR therapy in mCRC
Core message: “Tumor tissue from 146 mCRC patients was tested for RAS status with standard of care (SoC) PCR techniques, and Digital PCR (BEAMing) was used both in plasma and tumor tissue. Plasma RAS determination showed high overall agreement and captured a mCRC population responsive to anti-EGFR therapy with the same predictive level as SoC tissue testing. The feasibility and practicality of ctDNA analysis may translate into an alternative tool for anti-EGFR treatment selection.”

Annals of Oncology (2017): Vidal J. et al. Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients
Core message: RAS in tissue and plasma samples from 115 mCRC patients showed a 93% overall agreement using the OncoBEAM™ RAS CRC assay. Monitoring of RAS ctDNA in patients RAS wt showed that OncoBEAM was useful to detect RAS mutations during anti-EGFR treatment. It was finally concluded that the high overall agreement in RAS mutational assessment between plasma and tissue supports blood-based testing with OncoBEAM™ as a viable alternative for genotyping RAS of mCRC patients and that it is useful to monitor RAS in patients undergoing systemic therapy to detect potential treatment resistances.

Oncotarget (2017): Toledo R.A. et al. Clinical validation of prospective liquid biopsy monitoring in patients with wild-type RAS metastatic colorectal cancer treated with FOLFIRI-cetuximab
Core message: ”The current study provides evidences, obtained for the first time in an unbiased and prospective manner, that reinforces the utility of LqB for monitoring mCRC patients.”

ASCO (2016): Jones F.S. et al. Performance of Standardized BEAMing Platform for Detecting RAS Mutations in the Blood of Metastatic Colorectal Cancer (mCRC) Patients
Core message: “The high overall agreement of plasma and tissue RAS testing results (93.3%) demonstrates that blood-based OncoBEAMTM RAS CRC testing is a viable alternative to tissue-based RAS testing. Plasma RAS testing also provides an opportunity to monitor tumor RAS mutation dynamics during therapy in patients with systemic disease.”

ESMO (2016): Saunders M.P. et al. Performance assessment of blood based RAS mutation testing: concordance of results obtained from prospectively collected samples
Core message: “The high overall agreement of plasma and tissue RAS testing results (92.2%) shows that OncoBEAMTM RAS CRC testing is a viable alternative to tissue-based testing in this prospective study. Analysis of discordants shows that differences between plasma and tissue RAS results may arise from tumour heterogeneity, disease evolution, low ctDNA shedding, or low tumour burden.”

Molecular Oncology (2016): Schmiegel W. et al.Blood-based detection of RAS mutations to guide anti-EGFR therapy in colorectal cancer patients: Concordance of results from circulating tumor DNA and tissue-based RAS testing
Core message: ”The high concordance of plasma and tissue results demonstrates that blood-based RAS mutation testing is a viable alternative to tissue-based RAS testing.”

Nature Medicine (2015): Siravegna G. et al. Clonal Evolution and Resistance to EGFR Blockade in the Blood of Colorectal Cancer Patients
Core message: Liquid instead of tissue biopsy can be used to closely monitor the dynamic molecular evolution of metastatic colorectal tumors during anti-EGFR therapy in order to identify those patients that benefit from anti-EGFR.

Annals of Oncology (2015): Morelli M.P. et al. Characterizing the patterns of clonal selection in circulating tumor DNA from patients with colorectal cancer refractory to anti-EGFR treatment
Core message: ”Monitoring treatment-induced genetic alterations by sequencing ctDNA could identify biomarkers for treatment screening in anti-EGFR-refractory patients.”

The Lancet Oncology (2015): Tabernero J. et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial
Core message: BEAMing of circulating tumour DNA allowed the non-invasive analysis of tumour genotype in real time and the detection of tumour-associated mutations.

Science Translational Medicine (2014): Misale S. et al. Blockade of EGFR and MEK Intercepts Heterogeneous Mechanisms of Acquired Resistance to Anti-EGFR Therapies in Colorectal Cancer
Core message: Liquid biopsies used for monitoring RAS mutations of mCRC patients on anti-EGFR therapy enable early initiation of combination therapies with MEK inhibitors in order to optimize the therapy success and delay disease progression.

Nature (2012): Misale S. et al. Emergence of KRAS mutations and acquired resistance to anti-EGFR therapy in colorectal cancer
Core message: “…our results suggest that blood-based non-invasive monitoring of patients undergoing treatment with anti-EGFR therapies for the emergence of KRAS mutant clones could allow for the early initiation of combination therapies that may delay or prevent disease progression.”

Nature Medicine (2008): Diehl F. et al. Circulating mutant DNA to assess tumor dynamics
Core message: “We found that ctDNA measurements could be used to reliably monitor tumor dynamics in subjects with cancer who were undergoing surgery or chemotherapy. We suggest that this personalized genetic approach could be generally applied to individuals with other types of cancer.”

Lymph node localisation in colorectal cancer

Colorectal Disease (2016): Pouw et al. Ex vivo sentinel lymph node mapping in colorectal cancer using a magnetic nanoparticle tracer to improve staging accuracy: a pilot study
Core message: Based on 28 ex-vivo specimens of colorectal cancer, the authors concluded that ex vivo magnetic sentinel lymph node mapping with the Sentimag®/Sienna+® System is a feasible technique, which improves nodal staging accuracy.

IFMBE Proceedings (2010): ten Haken et al. Magnetic Detection of the Sentinel Lymph Node in Ex Vivo Tissue with Colorectal Cancer
Core message: The experimental approach on ex-vivo specimen indicated that SLN detection with Sentimag® is possible in colon cancer.

Sentinel lymph node localisation in prostate cancer

European Urology (accepted): Winter et al. Magnetic Resonance Imaging of Sentinel Lymph Nodes Using Intraprostatic Injection of Superparamagnetic Iron Oxide Nanoparticles in Prostate Cancer Patients: First-in-human Results.
Core message: The study in 50 patients with prostate cancer provided high sensitivity results in sentinel lypmph node biopsy with the Sentimag®/Sienna+® System and can be performed by an urologist alone.

Current Opinion in Urology (2017): Winter et al. Sentinel lymph node surgery in prostate cancer using magnetic particles
Core message: In this review it was concluded that SPION-MRI, combined with a hand-held magnetometer (Sentimag), provides a nonradioactive technique for preoperative and intraoperative SLN localization. Compared with ePLND, sPLND provides increased diagnostic value and supports the individualized extension of PLND using sPLND in prostate cancer.

Molecules (2017): Winter et al. Magnetic Marking and Intraoperative Detection of Primary Draining Lymph Nodes in High-Risk Prostate Cancer Using Superparamagnetic Iron Oxide Nanoparticles: Additional Diagnostic Value?
Core message: By using the Sentimag®/Sienna+® System in 104 patients with prostate cancer, the authors demonstrate the high sensitivity and additional diagnostic value of magnetometer-guided sentinel lymph node biopsy, exceeding that of ePLND.

European Urology Supplements (2017): Stanik et al. Sentinel lymph node dissection in prostate cancer using superparamagnetic particles of iron oxide: Early clinical experience.
Core message: Based on 20 patients with prostate cancer, the authors state, that the Sentimag®/Sienna+® method provides results comparable to radiotracer with the avoidance of radioactivity and preoperative imaging.

Annals of Surgical Oncology (2014): Winter et al. A novel method for intraoperative sentinel lymph node detection in prostate cancer patients using superparamagnetic iron oxide nanoparticles and a handheld magnetometer: the initial clinical experience.
Core message: First data of 20 patients with prostate cancer indicate that the sentinel lymph node biopsy with Sentimag®/Sienna+® is a simple, radiation-free, safe, feasible, and reliable method.

Lymph node analysis in colorectal cancer

Digestive and Liver Disease (2017) Marhic A. et al. Molecular analysis of sentinel lymph node in colon carcinomas by one-step nucleic acid amplification (OSNA) reduces time to adjuvant chemotherapy interval
Core message: Intraoperative analysis of SLNs by OSNA significantly reduces the time to adjuvant chemotherapy after surgery.

Surgical Endoscopy (2017) Yeung T.M. et al. Intraoperative identification and analysis of lymph nodes at laparoscopic colorectal cancer surgery using fluorescence imaging combined with rapid OSNA pathological assessment
Core message: “OSNA can be combined with NIR and ICG lymphatic mapping to provide intraoperative assessment of nodal tissue in patients with colorectal cancer.”

Journal of Translational Medicine (2017): Rakislova N. et al. Lymph node pooling: a feasible and efficient method of lymph node molecular staging in colorectal carcinoma
Core message: “LN pooling makes it possible to analyze a high number of LNs from surgical colectomies with few molecular tests per patient. This approach enables a feasible means to integrate LN molecular analysis from CC specimens into pathology diagnosis and provides a more accurate LN pathological staging with potential prognostic implications.”

Virchows Archiv (2016) Aldecoa I. et al. Molecularly determined total tumour load in lymph nodes of stage I-II colon cancer patients correlates with high-risk factors. A multicentre prospective study
Core message: OSNA allows the identification of tumour burden (undetected by hystology) in lymph nodes of early colon cancer patients. Moreover, the Total Tumour Load (TTL) determined by OSNA correlates with high-risk factors and may be used for a better selection of stage I–II patients at risk of recurrence.

Surgical Endoscopy (2016): Aldecoa I. et al. Endoscopic tattooing of early colon carcinoma enhances detection of lymph nodes most prone to harbor tumor burden
Core message: Endoscopic tattooing clearly improves identification of lymph nodes. Moreover, this method allows the detection of those lymph nodes most prone to carry tumor burden as demonstrated by the Total Tumour Load (TTL) values.

Annals of Surgical Oncology (2016): Yamamoto H. et al. OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan
Core message: High concordance between OSNA and histology. Besides, the TTL values determined by OSNA show to increase as the number of metastatic lymph node increases showing a trend compatible to the current pathological diagnosis system.

Annals of Surgical Oncology (2014): Vogelaar FJ. et al. The diagnostic value of one-step nucleic acid amplification (OSNA) for sentinel lymph nodes in colon cancer patients
Core message: The OSNA method shows a performance comparable to multilevel fine pathological examination. Since it enables whole lymph node analysis, sampling bias can be avoided leading to a more accurate tumour staging.

British Journal of Cancer (2014): Croner RS. et al. Molecular staging of lymph node-negative colon carcinomas by one-step nucleic acid amplification (OSNA) results in upstaging of a quarter of patients in a prospective, European, multicentre study
Core message: More than 25% of initially pN0 patients were upstaged by OSNA suggesting that this standardized and accurate method may improve staging.

Japanese Journal of Clinical Oncology (2013): Yamamoto N. et al. An optimal mRNA marker for OSNA (One-step nucleic acid amplification) based lymph node metastasis detection in colorectal cancer patients
Core message: A CK19 mRNA copy number cut-off of 75-500 copies/µl leads to a high sensitivity and specificity of the OSNA method.

Cancer (2012): Güller U. et al. Molecular investigation of lymph nodes in colon cancer patients using one-step nucleic acid amplification (OSNA): a new road to better staging?
Core message: The OSNA method shows comparable performance such as intensive histopathological evaluation and may lead to upstaging of more than 15% of colon cancer patients.

Annals of Surgical Oncology (2011): Yamamoto H. et al. OSNA-based novel molecular testing for lymph node metastases in colorectal cancer patients: results from a multicenter clinical performance study in Japan
Core message: OSNA can be considered a novel molecular examination tool for the staging of colon cancer patients.

Journal of Translational Medicine (2010): Croner RS. et al. One step nucleic acid amplification (OSNA) - a new method for lymph node staging in colorectal carcinomas
Core message: The OSNA method allows the rapid analysis of the whole node and can applied as tool to determine nodal status in colon cancer patients.

Magnetic impalpable lesion localisation

ABS Conference (2017): Harvey et al. Magseed – Safety and feasibility study of the use of magnetic marker seeds to localise breast cancers
Core message: Based on an initial experience in 29 breast cancer patients. All seed were detected and recovered without challenges. The author concluded, that Magseed is a safe and feasible device that offers accurate localisation and logistic enhancements.

Liquid biopsy in lung cancer

Oncotarget (2018): Garcia J. et al. Cross-Platform Comparison for the Detection of RAS mutations in cfDNA (ddPCR Bio-Rad detection assay, BEAMing assay, and NGS strategy)
Core message: This study compared the performance of the OncoBEAM™ RAS CRC IVD assay to ddPCR and NGS for the detection of KRAS/NRAS mutations in plasma from mCRC and NSCLC patients based of the analysis of paired blood and tissue samples. The OncoBEAM™ RAS CRC test revealed higher sensitivity than the two other technologies by testing cfDNA vs tissue analysis in mCRC and NSCLC samples (extended RAS panel) and enabled monitoring of somatic alterations in plasma-derived cfDNA.

Clinical Lung Cancer (2018): Taus A. et al. Dynamics of EGFR Mutation Load in Plasma for Prediction of Treatment Response and Disease Progression in Patients With EGFR-Mutant Lung Adenocarcinoma
Core message: OncoBEAM was applied for ctDNA-based assessment of EGFR mutations in a real-life setting before treatment and during disease progression showing a good correlation with tumour samples and in most cases predicted tumour response and progression before radiologic evaluation.

Clinical Cancer Research (2017): Yu H. et al. A Phase I, Dose Escalation Study of Oral ASP8273 in Patients with Non-small Cell Lung Cancers with Epidermal Growth Factor Receptor Mutations
Core message: OncoBEAM was able to detect inhibition of the drug target, predict response to therapy and detect emergence of drug resistance after therapy with a third-generation EGFR-TKI drug with high concordance to tissue testing (100%, 71% and 84% for EGFR L858R, exon 19 deletion and T790M, respectively).

Journal of Clinical Oncology (2016): Oxnard G.R. et al. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer
Core message: OncoBEAM was used in a retrospective analysis in the AURA trial for genotyping of ctDNA as a biomarker for predicting the outcome of a third-generation EGFR-TKI. Patients with T790M in plasma have outcomes with osimertinib comparable to T790M-positive patients by a tissue-based assay. EGFR T790M plasma genotyping had a false-negative rate of 30%, indicating that T790M-negative patients in plasma should undergo tissue biopsy.

Clinical Cancer Research (2016): Karlovich C.A. et al. Assessment of EGFR Mutation Status in Matched Plasma and Tumor Tissue of NSCLC Patients from a Phase 1 Study of Rociletinib (CO-1686)
Core message: The high positive percent agreement (PPA) between OncoBEAM plasma and tissue was 82% for activating mutations and 73% for T790M, concluding that OncoBEAM can be useful for the monitoring of T790M resistance mutation in NSCLC, which revealed a detection rate of > 90% for EGFR mutations (del19/L858R or T790M) in patients with extrathoracic disease (M1b).

Lung Cancer (2015): Thress K.S. et al. EGFR Mutation Detection in ctDNA from NSCLC Patient Plasma: A Cross-Platform Comparison of Leading Technologies to Support the Clinical Development of AZD9291
Core message: A comparison of EGFR mutation plasma detection platforms demonstrated highest sensitivity for OncoBEAM (Exon 19 del, L858R, T790M) whereas tumour heterogeneity may explain the reduced specificity of T790M mutations.

Journal of Thoracic Oncology (2015): Paz-Ares L. et al. MISSION Trial – A Phase III, Multi-Center, Placebo-Controlled Trial of Sorafenib in Patients with Relapsed or Refractory Predominantly Non-Squamous NSCLC after 2 or 3 Previous Treatment Regimens
Core message: OncoBEAM was applied to tumour and plasma samples to retrospectively analyse EGFR mutations, which seem to be a predictive biomarker for the efficacy of sorafenib in patients with advanced NSCLC.

Cancer Discovery (2015): Piotrowska Z. et al. Heterogeneity Underlies the Emergence of EGFRT790 Wild-Type Clones Following Treatment of T790M-Positive Cancers with a Third-Generation EGFR Inhibitor
Core message: OncoBEAM was used to assess the impact of the EGFR T790M mutation status in the context of rociletinib treatment demonstrating that T790M clearance could lead to resistance. Furthermore, tumour heterogeneity has important clinical implications since the degree of heterogeneity may be a predictor of rociletinib response, and liquid biopsy can overcome this limitation of tissue biopsy.

Annals of Oncology (2014): Thress K.S. et al. Levels of EGFR T790M in plasma DNA as a predictive biomarker for response to AZD9291, a mutant-selective EGFR kinase inhibitor (1270P)
Core message: Comparing plasma levels of EGFR-TKI-sensitising mutations with those of the tumour, OncoBEAM showed 87 % overall sensitivity and 78 % sensitivity for T790M mutations (profiling of 100 EGFR mutation-negative plasma samples yielded no false positives) proving that OncoBEAM represents an alternative for tumour genotyping when an evaluable tumour re-biopsy is not available.

Clinical Cancer Research (2011): Taniguchi K. et al. Quantitative Detection of EGFR Mutations in Circulating Tumor DNA Derived from Lung Adenocarcinomas
Core message: In plasma from patients with and without EGFR-TKI treatment, the activating and resistant mutations were quantified by OncoBEAM, revealing a peak of the distribution of the mutant allele fraction (MAF) in the 0.1 % to 1 % range.

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