Advice

Summary

Summary

  • The technology described in this briefing is HTG EdgeSeq ALKPlus Assay EU. It is used to identify mRNA ALK gene fusion events in lung tumour specimens taken from people with non-small-cell lung cancer (NSCLC).

  • The innovative aspects are that the test automatically generates a report on ALK status that any clinician can interpret.

  • The intended place in therapy would be to replace current methods of ALK status testing in people with NSCLC.

  • No publically available evidence was found about the use of the assay.

  • Key uncertainties around the evidence or technology is the lack of evidence on its diagnostic accuracy. Studies which specifically assess its diagnostic accuracy and compare it with current methods of ALK status testing are essential.

  • The cost of HTG EdgeSeq ALKPlus Assay EU is £250 to £300 per test (excluding VAT). The resource impact would be higher costs compared with current methods of ALK status testing.