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Molecular nodal staging with OSNA

Our OSNA solutions

OSNA – One Step Nucleic Acid Amplification – is an automated molecular diagnostic assay to determine the metastatic burden in the lymph nodes (LN).  OSNA solutions from Sysmex are available for breast cancer, colorectal cancer, gastric cancer, prostate cancer, lung cancer and gynaecological cancers. Especially in early stage disease, an accurate nodal assessment is of utmost importance to decide on further surgical and adjuvant treatment.

The outcome of studies form more than 60,000 patients highlights OSNA's clinical value and CK19 copy number for SLN assessment, offering predictive and prognostic insights surpassing standard pathology. This aids in safely tailoring further surgery and adjuvant treatment, enabling personalised treatments and enhancing patients' quality of life.

Molecular nodal staging with OSNA: As fast as frozen section, as sensitive as ultra-staging – Definitive molecular nodal staging within 30min

  • Quantitative nodal tumour burden beyond micro/macro metastases allows for surgical de-escalation and improved patient quality of life
  • Predictive and prognostic information beyond positive node count for confident patient risk stratification
  • Saves valuable time for surgeons, pathologists, and patients
  • Easy, reliable and standardised
About OSNA

How to reveal the whole picture with OSNA

OSNA is an automated rapid molecular diagnostic test for the detection of lymph node metastases. It analyses the entire lymph node tissue using a reverse transcriptase loop-mediated isothermal amplification reaction (RT-LAMP*) to quantify tumour-specific cytokeratin 19 (CK19) mRNA expression in LNs. CK19 is a typical epithelial cell marker of human malignant cells, not present in healthy LN tissue. Its expression rate correlates with the size of the metastatic foci and gives a clear indication of the metastatic tumour burden in the lymph nodes. This in turn allows precise staging – the prerequisite for treatment decision-making.

What you get with all OSNA products

  • Accurate whole-node metastatic tumour burden quantification
  • Highly sensitive molecular in-vitro diagnostic
  • Standardised, objective results thanks to automated analyser
  • Fast availability of results (~20min for 1 LN; ~30min for 14 LNs)
  • Easy-to-use integrated user interface and ready-to-use reagents
  • High flexibility (pan-cancer/ multi-patient)
  • Improved patient quality of life with shorter waiting time, less stress and earlier start of adjuvant therapies
  • IVDR CE-marked

* licensed under the agreement with Eiken Chemical CO., LTD

About molecular staging

Why molecular nodal staging?

Determining the malignant status of lymph nodes (LN) is an important step in staging cancers because it influences the need and type of surgery and adjuvant therapies.

Frozen section is the most commonly used technique for intraoperative LN assessment, yet it suffers from low sensitivity compared to post-operative pathological examination. The latter is mainly attributed to the low detection rate of micro-metastases and isolated tumour cells. The use of multi-step formalin fixed tissue sections stained by haematoxylin and eosin, with or without, immunohistochemistry increases the detection rate of low volume disease. Nonetheless, a significant number of micro-metastases can still be overlooked because during histological work-up, only small parts of LNs are typically screened. Furthermore, the histology-based technique is often time-consuming and can be subjected to observation error. As such, it is not ideal for intra-operative assessment, especially when a high number of LNs must be investigated. [2]

Analysing lymph node tissue reliably and accurately is therefore crucial for detecting the real metastatic nodal tumour burden and precisely staging cancer patients.

From users

What do users say about OSNA?

OSNA described in one word: Check out the video below to hear it directly from our customers.

OSNA RD-210 workflow

OSNA RD-210 workflow

Growing your knowledge

During the OSNA international virtual forum, 25+ experts and KOLs from different disciplines present the latest OSNA developments and OSNA’s impact on nodal staging and cancer management. Watch the OSNA international forum below.

Discover our OSNA solutions

LYNOAMP CK19 E

LYNOAMP CK19 E

OSNA amplification reagent

Details
RD-210

RD-210

OSNA gene amplification detector

Details
RP-10

RP-10

OSNA pretreatment system

Details
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