Over the past month, the Food and Drug Administration (FDA) has approved two tests to identify genetic alterations in tumors.

 

The most recent approval, on December 1, is the FoundationOne CDx (F1CDx) genomic test, which can identify cancer-associated alterations in 324 genes and two types of genomic alterations—called genomic signatures—in any type of solid tumor.

 

Among other uses, the approval allows F1CDx to be used as a companion diagnostic test for 15 different targeted therapies used to treat five types of cancer (see table at bottom). A companion diagnostic is used to determine whether a patient is a candidate for a specific therapy by identifying whether their tumor has a specific genetic alteration.

 

Data that led to the test’s approval showed that it could accurately detect selected mutation types about 95% of the time.

 

On the same day, the Centers for Medicare & Medicaid Services (CMS) proposed national coverage of F1CDx and certain other diagnostic tests that use next-generation sequencing technology, which can rapidly analyze many genes simultaneously.

 

The proposed coverage includes the use of these tests in patients with recurrent or metastatic solid cancers who have not previously used the test and who wish to pursue further treatment for which the test can serve as a companion diagnostic.