Foundation Medicine’s FoundationOne CDx Receives FDA’s Approval as a CDx for Lynparza (olaparib)

Shots:

• The US FDA approved FoundationOne CDx as a CDx for Lynparza (co-developed & co-commercialized by Merck & AstraZeneca) for 1L maintenance therapy in BRCA-mutated advanced ovarian cancer
• The test detects both germline and somatic mutations in BRCA1 and BRCA2 tumors and identify more patients to get benefit from Lynparza in comparison to other testing methods identifying germline BRCA mutations only
• FoundationOne CDx is a sequencing based in vitro diagnostic device that detects mutations in 324 genes, select gene rearrangements, and genomic signatures including MSI & TMB and has received FDA’s approval for all solid tumors

Click here to read full press release/ article | Ref: Foundation Medicine | Image: Roche