Summary

Summary

  • The technology described in this briefing is the OSNA in vitro diagnostic molecular assay system. It is used for detecting lymph node metastases in people with colon cancer.

  • The innovative aspects of OSNA are that unlike standard histopathology, OSNA can analyse the whole lymph node as well as partial lymph nodes. This may improve cancer staging accuracy because it reduces tissue allocation bias.

  • The intended place in therapy would be as an alternative to standard post‑operative histopathology for lymph node staging in people after surgical resection for early stage colon cancer.

  • The key points from the evidence summarised in this briefing are from 3 prospective observational studies including 253 people. The studies found that the diagnostic performance of OSNA was better than standard histopathology and that the results with OSNA led to upstaging from lymph node negative to lymph node positive in up to one‑quarter of the study population.

  • A key uncertainty around the evidence is that none of the studies investigated OSNA for analysing the whole lymph node, which is described as a key innovation for the system.

  • The average cost per patient (including capital, maintenance, and disposable costs) ranges from £568 to £608 (excluding VAT), depending on the cost of disposables (reagents and consumables).