The FDA has approved two comprehensive genomic profiling liquid biopsy tests for use in supporting doctors with their treatment decision-making.
• Guardant360 CDx, from Guardant Health, Redwood City, Calif, which was approved on August 7, 2020, utilizes liquid biopsy as well as NGS to technology to simultaneously detect mutations in 55 tumor genes.1 The Guardant360CDx is approved both to provide information on multiple solid tumor biomarkers and to help identify EGFR mutations in patients who will benefit from treatment with Tagrisso (osimertinib), an FDA-approved therapy for a form of metastatic NSCLC.
• FoundationOne Liquid CDx, from Foundation Medicine, Cambridge, Mass, was initially approved on August 26, 2020, to detect mutations in more than 300 tumor genes. It was also approved as a companion diagnostic (1) 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) and (2) to identify select EGFR deletions and substitutions in patients with non-small cell lung cancer for treatment with gefitinib (Iressa), Osimertinib (Tagrisso), and erlotinib (Tarceva).2
In October and November 2020, the FDA approved FoundationOne Liquid CDx test as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens, including (1) to identify mutations in BRCA1 and BRCA2 genes in patients with ovarian cancer eligible for treatment with rucaparib (Rubraca); (2) to identify ALK rearrangements in patients with NSCLC eligible for treatment with alectinib (Alecensa); (3) to identify mutations in the PIK3CA gene in patients with breast cancer eligible for treatment with alpelisib (Piqray); and (4) to identify mutations in BRCA1, BRCA2, and ATM genes in patients with metastatic castration-resistant prostate cancer (mCRPC) eligible for treatment with olaparib (Lynparza).3
Read more in Advances in Liquid Biopsy from CLP.—Laurie Bonner
Laurie Bonner is chief editor of Clinical Lab Products.
1. US Food and Drug Administration. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test [press release]. August 7, 2020. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test.
2. US Food and Drug Administration. FDA approves liquid biopsy next-generation sequencing companion diagnostic test [press release]. August 16, 2020; updated September 15, 2020. Available at https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test.
3. US Food and Drug Administration. FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers [press release]. Updated November 9, 2020. Available at https://www.fda.gov/drugs/fda-approves-liquid-biopsy-ngs-companion-diagnostic-test-multiple-cancers-and-biomarkers.