RESEARCH_DNA-graphic

Detecting genetic mutations in vitro:

On November 30, 2017, the Food and Drug Administration granted marketing approval to the FoundationOne CDx (F1CDx, Foundation Medicine, Inc.), a next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.

The test can also identify which patients with non-small cell lung cancer (NSCLC), melanoma, breast cancer, colorectal cancer, or ovarian cancer may benefit from 15 different FDA-approved targeted treatment options.

Clinical performance of the test was established through a least burdensome means by comparing the F1CDx to previously FDA-approved companion diagnostic tests that are currently used to determine patient eligibility for certain treatments. Results indicated that the test’s ability to detect select mutation types (substitutions and short insertions and deletions) representative of the entire 324 gene panel is accurate approximately 94.6% of the time.

This is the first device with the FDA’s Breakthrough Device designation to complete the premarket approval (PMA) process, and it is the second IVD authorized under the FDA and Centers for Medicare & Medicaid Services’ (CMS) Parallel Review program. Under this program, the CMS issued a proposed national coverage determination of the F1CDx for Medicare beneficiaries with recurrent, metastatic, or advanced stage IV cancer who have not been previously tested using NGS technology and who continue to remain candidates for further therapy.

The FDA reviewed the F1CDx application using a coordinated, cross-agency approach. The FDA Center for Devices and Radiological Health (CDRH) conducted the clinical review with support from the FDA Oncology Center of Excellence, while CDRH conducted all other review aspects and made the final product approval determination.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine or device to FDA’s MedWatch Reporting System.

Learn more about lung cancer targeted treatments for genetic mutations.

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