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RD-210

  • Short TAT (approx. 15m for 1 sample, approx. 30m for 14 samples)
  • High flexibility (multi-application/multi-patient usage)
  • Simple reagent management and consumption traceability by QR Code identification

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OSNA – Advanced platform for analysing lymph nodes

Nodal status matters

More differentiated information – Supporting better treatment decisions

Lymph node status is one of the most important prognostic factors in many cancers and a key criterion for surgical and therapeutic decisions. Analysing lymph node tissue reliably and accuracy is therefore crucial for detecting metastases.

Routine practice in histopathology analyses only a limited amount of tissue and therefore provides only limited information, which might not reflect the real metastatic burden.

OSNA® – One Step Nucleic Acid Amplification – is an automated molecular diagnostic assay that analyses the entire lymph node tissue. The reaction is based on rapid nucleic acid amplification technology (RT-LAMP*) to quantify Cytokeratin 19 (CK19) mRNA expression. CK19 is an epithelial cell marker and is not normally present in lymph node tissue. The expression rate of CK19 mRNA correlates with the size of the metastatic foci.

 

OSNA – Benefits

Superior diagnostic information

  • More accurate determination of the metastatic burden by analysing the entire lymph node
  • Standardised, objective assessment of the lymph node status


Confidence

  • Fast availability of results for optimal decision-making as to the right surgical/ non-surgical approach
  • Confident staging as reliable basis for choosing therapy


Patient quality of life

  • Next therapy measures can start earlier
  • Reduced waiting time and less patient stress


* RT-LAMP = Reverse transcriptase loop-mediated isothermal amplification; licensed under the agreement with Eiken Chemical CO., LTD

Oncology

OSNA for Breast Cancer

OSNA for Breast Cancer

Choose OSNA and fine-tune your treatment decision

More than 100 publications provide evidence on the clinical utility of using OSNA® and the CK19 copy number for breast cancer patients. They show that CK19 provides predictive and prognostic information beyond conventional pathology assessment.  This helps to deliver less invasive interventions, more personalised treatment and improves patients’ quality of life.

OSNA BC in routine use

OSNA BC in routine use

The efficency of the OSNA® test procedure has been confirmed in several clinical studies worldwide, where the method was compared with a highly differentiated histopathological processing of alternating lymph node tissue samples.

For the OSNA® test these multicentre studies demonstrated concordance, sensitivity and specificity of over 95% compared to the histological findings.

There have been a host of publications by routine users, who describe the comparability of the method and the avoidance of second operations, along with other benefits of OSNA®.

The evaluation of the available patient results shows that there is a correlation between the OSNA® result and the axillary lymph node status. The CK19 mRNA copy number has been shown to be a statistically significant parameter in predicting the risks of further positive axillary lymph nodes. Users have already started to develop statistical calculation models (nomograms) to predict the nodal status from the CK19 copy number in combination with other prognostic factors.

This aspect is of particular importance in relation to more recent study results, which are having a key impact on the therapeutic measures undertaken in patients with positive sentinel nodes. Thus women in the very early stage of breast cancer whose lymph node involvement is very low (only micrometastases, max. 2 positive sentinel nodes) do not need to undergo an axillary lymph node dissection (ALND).

The OSNA® result is a convincing parameter in determining the best therapeutic decision and selecting this group of patients.

OSNA for Colorectal Cancer

OSNA for Colorectal Cancer

Choose OSNA® for more reliable staging and make immediate treatment decisions

Lymph node analysis is usually performed using classical histopathology methods. In doing so, the lymph node is only analysed on one level, leaving a large amount of tissue unanalysed. As a result, metastases may remain undetected and lead to false negative results and a higher risk of recurrences for patients.

By analysing the entire lymph node, OSNA® delivers the confidence that you do not overlook any metastases and so can deliver accurate staging of the patients and a more reliable basis for your therapy decision.

Studies have shown that a lymph node analysis of pN0 patients with OSNA® yielded an upstaging rate of approximately 25%, compared with the standard histological method. These patients' therapies could therefore be adjusted accordingly.

OSNA CC in routine use – clinical studies

OSNA CC in routine use – clinical studies

Studies have shown that a lymph node analysis of pN0 patients with OSNA® yielded an upstaging rate of approximately 25%, compared with the standard histological method. These patients' therapies could thus be adjusted accordingly.

OSNA for Gastric Cancer

OSNA for Gastric Cancer

Using the sentinel concept, the need for surgery is often reduced. This is true for several different types of cancer, including gastric cancer. In early gastric cancer, lymph node metastasis occurs in some 10-16% of cases. As such, surgery is often not necessary for these patients. The intraoperative OSNA® result can support immediate decision for further lymph node dissection YES/NO

Publications

Publications

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Contact


lifescience@sysmex-europe.com
Bornbarch 1
22848 Norderstedt
Germany

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