NEW YORK (GenomeWeb) – Myriad Genetics today announced it has received approval from the US Food and Drug Administration for BRACAnalysis CDx as a companion diagnostic for AstraZeneca's Lynparza (olaparib), a new drug for advanced ovarian cancer associated with BRCA genes.
BRACAnalysis CDx is an in vitro diagnostic assay that detects genetic defects in the BRCA1/2 genes using genomic DNA obtained from whole blood samples from patients with ovarian cancer. In clinical studies, the test was proven to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The test is for professional use only and is to be performed at Myriad Genetic Laboratories in Salt Lake City.
The FDA also announced the concurrent approval of Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
The FDA's approval of the companion diagnostic is based on data from the clinical study used to support approval of the new drug. Blood samples from clinical trial participants were tested to validate the test's use for detecting BRCA mutations in this population. The agency evaluated BRACAnalysis CDx's safety and efficacy under its premarket approval pathway used for high-risk medical devices. Until now, Myriad, a clinical laboratory, had been marketing this test without FDA approval as a laboratory developed test, although not specifically for use as a companion diagnostic.
"The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement. He added that the BRACAnalysis CDx is the agency's "first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic."
Salt Lake City-based Myriad said in a statement that BRACAnalysis CDx represents the culmination of a multi-year scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer. Myriad said it is also collaborating with several other pharmaceutical companies to evaluate the companion diagnostic for use with other PARP inhibitors and chemotherapy drugs.
In October, Myriad opened a European laboratory in Munich to offer BRACAnalysis CDx.