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FDA okays test for many cancer-causing genes

04 December 2017

By Theofanis Michailidis

Appeared in BioNews 929

The US Food and Drug Administration (FDA) has approved a test which can detect cancer-causing mutations in 324 genes.

The test, known as Foundation One CDX (F1CDx), is the first FDA-approved single genetic test for large range of cancers. F1CDx, made by Foundation Medicine, has the unique attribute of looking for a mutation in hundreds of cancer genes simultaneously, searching for two genomic signatures in any solid tumour type. The results will allow physicians to identify the specific mutations from a patient's tumour sample, and find the most effective treatment.

'With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options,' said Dr Jeffrey Shuren, director of the FDA's Centre for Devices and Radiological Health

The single test will mean there is no need for multiple biopsies for successive, single-gene tests. This can help avoid 'the often invasive process of extracting tumour samples multiple times to determine eligibility for a single treatment or enrolment in a clinical trial', Dr Shuren said. 

FDA Commissioner, Dr Scott Gottlieb, added that the test would give patients faster access to 'a breakthrough diagnostic' test that could 'potentially reduce health care costs'. The Centres for Medicare and Medicaid Services have proposed covering the test. As a result, tumour-gene profiling is likely to become available to a greater number of cancer patients.

Previously, private insurers were reluctant to cover similar tests, because of the lack of satisfactory evidence of benefit, Reuters reports. This is now set to change, as the approval of F1CDx sets a precedent for coverage determinations by private insurers.

'This will be a sea change' for patients, Dr Richard Schilsky, chief medical officer of the American Society of Clinical Oncology, told ABC News.

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