The recent U.S. Food and Drug Administration (FDA) of olaparib (Lynparza) occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with BRCA mutations are more likely to get ovarian cancer, and it is estimated that 10% to 15% of all ovarian cancer is associated with these hereditary BRCA mutations.
The FDA evaluated the BRACAnalysis CDx’s safety and efficacy under the agency’s premarket approval pathway used for high-risk medical devices. Until now, Myriad Genetics had been marketing this test, although not specifically for use as a companion diagnostic, without FDA approval as a laboratory-developed test, which is a test that is designed, manufactured, and used in a single laboratory. The new test is approved as a companion diagnostic, specifically to identify patients with advanced ovarian cancer who may be candidates for treatment with olaparib.
“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an laboratory-developed test under a premarket approval application and is the first approval of an laboratory-developed test companion diagnostic. The use of companion diagnostics helps bring to market safe and effective treatments specific to a patient’s needs.”
The FDA’s approval of the BRACAnalysis CDx is based on data from the clinical study used to support approval of olaparib. Blood samples from clinical trial participants were tested to validate the test’s use for detecting BRCA mutations in this population.
BRACAnalysis CDx’s application was reviewed under the FDA’s priority review program for devices, which provides for priority review of devices that meet certain criteria, including that the devices are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and, if approved, would offer significant, clinically meaningful advantages compared to marketed