Myriad Genetics, Salt Lake City, has submitted a supplementary premarket approval application to FDA for its myChoice companion diagnostic to help identify women with advanced ovarian cancer who are potential candidates for maintenance therapy with Lynparza (olaparib) in combination with bevacizumab. Myriad’s filing is based on positive results from the Phase 3 Paola-1 trial of Lynparza published in December 2019.1 Lynparza is marketed by AstraZeneca, Cambridge, UK, and Merck, Kenilworth, NJ.

“This regulatory submission represents another important milestone for the myChoice companion diagnostic,” says Nicole Lambert, president of Myriad oncology and women’s health. “Our goal is to improve patient care through precision medicine and ensure that women with advanced ovarian cancer have access to targeted therapies.”

Myriad’s myChoice companion diagnostic is the most comprehensive homologous recombination deficiency test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice companion diagnostic comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions).

For more information, visit Myriad Genetics.


1. Ray-Coquard I, Pautier P, Pignata S, et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416–2428; doi: 10.1056/NEJMoa1911361.