Menu

Foundation Medicine’s Cancer Gene Test Gains FDA and CMS Approval

The Centers for Medicare and Medicaid Services propose covering the test with Medicare. 

Dec 1, 2017
Diana Kwon

FLICKR, FDAOn Thursday (November 30), the US Food and Drug Administration (FDA) approved Foundation Medicine’s in vitro diagnostic test for solid tumor cancers. This diagnostic tool is designed to help physicians identify which patients would benefit from more than a dozen FDA-approved targeted treatment options and determine candidacy for clinical trials. The Centers for Medicare and Medicaid Services (CMS) concurrently submitted a preliminary National Coverage Determination for the device, proposing coverage for Medicare patients.

The Cambridge-based company’s test, FoundationOne CDx (F1CDx), can detect cancer-causing mutations in 324 genes for any solid tumor, including those in the breast, lungs, and ovaries. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, says in a statement.

F1CDx is the second in vitro diagnostic test to receive coordinated approval by the two agencies through the FDA-CMS Parallel Review Program, which aims to give Medicare beneficiaries earlier access to new medical technologies. The first was a noninvasive colorectal cancer test developed by Exact Sciences, which was greenlighted by the FDA in 2014.

This program “allowed the sponsor to win approval for this novel diagnostic and secure an immediate proposed Medicare coverage determination within six months of the FDA receiving the product application,” FDA Commissioner Scott Gottlieb says in a statement.

See “Opinion: More Biomarkers Needed for Cancer Immunotherapy” 

January 2019

Cannabis on Board

Research suggests ill effects of cannabinoids in the womb

Marketplace

Sponsored Product Updates

WIN a VIAFLO 96/384 to supercharge your microplate pipetting!
WIN a VIAFLO 96/384 to supercharge your microplate pipetting!
INTEGRA Biosciences is offering labs the chance to win a VIAFLO 96/384 pipette. Designed to simplify plate replication, plate reformatting or reservoir-to-plate transfers, the VIAFLO 96/384 allows labs without the space or budget for an expensive pipetting robot to increase the speed and throughput of routine tasks.
FORMULATRIX® digital PCR technology to be acquired by QIAGEN
FORMULATRIX® digital PCR technology to be acquired by QIAGEN
FORMULATRIX has announced that their digital PCR assets, including the CONSTELLATION® series of instruments, is being acquired by QIAGEN N.V. (NYSE: QGEN, Frankfurt Stock Exchange: QIA) for up to $260 million ($125 million upfront payment and $135 million of milestones).  QIAGEN has announced plans for a global launch in 2020 of a new series of digital PCR platforms that utilize the advanced dPCR technology developed by FORMULATRIX combined with QIAGEN’s expertise in assay development and automation.
Application of CRISPR/Cas to the Generation of Genetically Engineered Mice
Application of CRISPR/Cas to the Generation of Genetically Engineered Mice
With this application note from Taconic, learn about the power that the CRISPR/Cas system has to revolutionize the field of custom mouse model generation!
Translational Models of Obesity, Dysmetabolism, Diabetes, and Complications
Translational Models of Obesity, Dysmetabolism, Diabetes, and Complications
This webinar, from Crown Bioscience, presents a unique continuum of translational dysmetabolic platforms that more closely mimic human disease. Learn about using next-generation rodent and spontaneously diabetic non-human primate models to accurately model human-relevant disease progression and complications related to obesity and diabetes here!