FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

 

On August 26, 2020, the Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic to identify mutations in BRCA1 and BRCA2 genes in cell free-DNA isolated from plasma specimens from patients with metastatic castration-resistant prostate cancer (mCRPC) eligible for treatment with rucaparib (RUBRACA, Clovis Oncology, Inc.).

On May 15, 2020, the FDA granted accelerated approval for rucaparib for patients with deleterious BRCA1 or BRCA2 mutation (germline and/or somatic)-associated mCRPC who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. 

View the Summary of Safety and Effectiveness for the FoundationOne® Liquid CDx test (P190032).

The FoundationOne Liquid CDx test was granted Breakthrough Device designation , for the identification of mCRPC eligible for treatment with rucaparib and for the identification of EGFR mutations in patients with non-small cell lung cancer for treatment with certain EGFR tyrosine kinase inhibitors on April 2, 2018. A description of the FDA Breakthrough Device program can be found at Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

For information on the COVID-19 pandemic, see the following resources:

• FDA: Coronavirus Disease 2019 (COVID-19)
• NCI: Coronavirus: What People With Cancer Should Know
• CDC: Coronavirus (COVID-19)

Follow the Oncology Center of Excellence on Twitter @FDAOncology.