FDA News

FDA approves FoundationOne CDx to detect cancer biomarkers

The FDA approved a next-generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor.

Additionally, CMS proposed coverage of the test.

The FDA has approved other companion diagnostics that match one test to one drug.

FoundationOne CDX (Foundation Medicine Inc.) is designed to be a more extensive test that provides information about several genetic mutations that may help guide treatment of patients with cancer.

Test results show the diagnostic, commonly called F1CDx, can identify patients with any of five tumor types — non-small cell lung cancer, melanoma, breast cancer, colorectal cancer or ovarian cancer — who may derive benefit from any of 15 FDA-approved targeted treatments.

“F1CDx can help cancer patients and their health care professionals make more informed care decisions without the often-invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in an FDA-issued press release. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.”

CMS also issued a proposed national coverage determination for F1CDx and other similar next-generation sequencing in vitro diagnostic tests for Medicare beneficiaries with advanced cancer who have not previously undergone testing by next-generation sequencing technology.

F1CDx is the second in vitro diagnostic to be approved and covered after overlapping review by FDA and CMS through the Parallel Review Program.

“Through parallel review and collaboration, we speed access to innovative diagnostics so that doctors are better able to deliver the best-quality care to their patients and patients have access to these state-of-the-art tests,” Seema Verma, administrator of CMS, said in the release.

The approval and proposed coverage determination were based in part on data from a trial that compared F1CDx with previously approved diagnostic tests. F1CDx accurately detected substitutions, short insertions and deletions of 324 genes in 94.6% of cases.

The FDA had granted breakthrough device designation to the F1CDx application.

The FDA approved a next-generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor.

Additionally, CMS proposed coverage of the test.

The FDA has approved other companion diagnostics that match one test to one drug.

FoundationOne CDX (Foundation Medicine Inc.) is designed to be a more extensive test that provides information about several genetic mutations that may help guide treatment of patients with cancer.

Test results show the diagnostic, commonly called F1CDx, can identify patients with any of five tumor types — non-small cell lung cancer, melanoma, breast cancer, colorectal cancer or ovarian cancer — who may derive benefit from any of 15 FDA-approved targeted treatments.

“F1CDx can help cancer patients and their health care professionals make more informed care decisions without the often-invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in an FDA-issued press release. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.”

CMS also issued a proposed national coverage determination for F1CDx and other similar next-generation sequencing in vitro diagnostic tests for Medicare beneficiaries with advanced cancer who have not previously undergone testing by next-generation sequencing technology.

F1CDx is the second in vitro diagnostic to be approved and covered after overlapping review by FDA and CMS through the Parallel Review Program.

“Through parallel review and collaboration, we speed access to innovative diagnostics so that doctors are better able to deliver the best-quality care to their patients and patients have access to these state-of-the-art tests,” Seema Verma, administrator of CMS, said in the release.

The approval and proposed coverage determination were based in part on data from a trial that compared F1CDx with previously approved diagnostic tests. F1CDx accurately detected substitutions, short insertions and deletions of 324 genes in 94.6% of cases.

The FDA had granted breakthrough device designation to the F1CDx application.