FDA approves Foundation Medicine pan-tumor liquid biopsy test
The FDA approved FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test.
FoundationOne Liquid CDx (Foundation Medicine) is a qualitative next-generation sequencing-based in vitro diagnostic test that analyzes 324 genes and genomic signatures to help guide treatment decisions for patients with solid tumors.
The test uses cell-free DNA isolated from plasma derived from anticoagulated peripheral whole blood of patients with advanced cancer to analyze genes for alterations.
Results are presented in a report that identifies alterations matched to FDA-approved therapies. They also provide additional insights that can inform use of immunotherapy or other treatments, as well as information about relevant clinical trials.
The FDA based the approval on results of clinical and analytical validation studies that included more than 7,500 samples and 30,000 unique variants representing more than 30 cancer types. Results showed high sensitivity and specificity, including at low allele frequencies, according to Foundation Medicine.
“We believe that [patients with cancer] and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine, said in a company-issued press release. “FoundationOne Liquid CDx underscores our commitment to advance patient care across all cancer types by bringing forward multiple FDA-approved comprehensive genomic profiling options that are increasingly essential for high-quality cancer care.
“We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which — if approved — would further enhance utility of the test in clinical practice,” Alexander added. “Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”
The approval includes companion diagnostic claims for rucaparib (Rubraca, Clovis Oncology) — a poly(ADP-ribose) polymerase (PARP) inhibitor approved for men with metastatic prostate cancer who harbor BRCA1/BRCA2 mutations — as well as for three tyrosine kinase inhibitors approved for first-line treatment of non-small cell lung cancer: gefitinib (Iressa, AstraZeneca), osimertinib (Tagrisso, AstraZeneca) and erlotinib (Tarceva; Genentech, Astellas).
“Liquid biopsies are becoming an increasingly important option to inform personalized treatment decisions for physicians treating certain [patients with advanced cancer] who require minimally invasive solutions to genomic testing,” Mark Socinski, MD, executive director and medical oncologist at AdventHealth Cancer Institute in Florida, said in the release. “This approval helps expand access to important genomic information needed for physicians to make more informed decisions about targeted treatment approaches for their patients, and is another important step toward making comprehensive genomic testing a part of routine clinical cancer care.”