The approval made BRACAnalysis CDx the only germline test to get the FDA’s nod as a companion diagnostic for treatment of HER2 negative high-risk early-stage breast cancer with Lynparza (olaparib).
Myriad Genetics started its collaboration with AstraZeneca on olaparib in 2007. (Credit: fernando zhiminaicela from Pixabay)
Genetic testing and precision medicine company Myriad Genetics has received approval from the US Food and Drug Administration (FDA) for its BRACAnalysis CDx test.
The approval has been given for use of BRACAnalysis CDx as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) HER2 negative, high-risk early-stage breast cancer who are eligible for treatment with Lynparza (olaparib), which is being commercialised by AstraZeneca and MSD.
The BRACAnalysis CDx test is developed to identify deleterious or suspected deleterious germline BRCA variants in patients with HER2 negative high-risk early breast cancer.
According to the company, the companion test can detect and interpret germline BRCA1 and BRCA2 variants.
The OlympiA trial led by the Breast International Group has shown a significant clinical improvement in patients with HER2 negative early-stage breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants, and high-risk clinicopathological factors.
Myriad Genetics chief operating officer Nicole Lambert said: “This most recent regulatory approval confirms the benefits of using biomarkers to help guide care for patients with breast cancer.
“Data from the OlympiA trial and numerous other clinical studies continue to demonstrate the power of BRACAnalysis CDx as an effective test for patients deciding on their best treatment options. More patients with breast cancer now potentially qualify for BRCA testing.”
Myriad Genetics started its collaboration with AstraZeneca on olaparib in 2007.
The company received FDA approval of BRACAnalysis CDx for patients with ovarian cancer. In December 2014, and for patients with HER2 negative metastatic breast cancer in January 2018.
In September last year, Myriad Genetics completed the sale of select operating assets and intellectual property (IP), including the Vectra test, held by its autoimmune business unit to Labcorp for $150m.