OSNA for colon cancer staging

NICE has developed a medtech innovation briefing (MIB) on OSNA for colon cancer staging.

• 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).

MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.

Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.

MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.

MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.