Personalized medicine molecular diagnostics firm Myriad Genetics has secured approval from the US Food and Drug Administration (FDA) for its BRACAnalysis CDx companion diagnostic test to identify patients with HER2-negative metastatic breast cancer (mBC).
The approval allows BRACAnalysis CDx to be used as companion diagnostic for Pfizer’s poly ADP ribose polymerase (PARP) inhibitor Talzenna (talazoparib).
Talzenna is used to treat adult patients with deleterious or suspected deleterious germline (inherited) BRCA-mutated HER2-negative locally advanced or mBC.
Myriad Oncology president Lloyd Sanders said: “We congratulate Pfizer on obtaining FDA approval of TALZENNA for certain patients living with metastatic breast cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test.
“We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test.”
The FDA approvals are based on data from the Embraca study, which assessed Talzenna against physician’s choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or mBC.
BRACAnalysis CDx is an in vitro diagnostic device, which will be used to qualitatively detect and classify variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA.
Polymerase chain reaction (PCR) and Sanger sequencing are used to identify single nucleotide variants and small insertions and deletions (indels). Multiplex PCR will help in detecting BRCA1 and BRCA2.
According to the company, the assay is for professional use only and is to be carried out only at Myriad Genetic Laboratories.
Myriad Genetics chief medical officer Johnathan Lancaster said: “Myriad’s BRACAnalysis CDx test was shown in the EMBRACA trial to accurately identify certain patients with a germline BRCA-mutation who may benefit from TALZENNA.
“It is important for patients to know their BRACAnalysis CDx results so they can fully understand their treatment options.”
Myriad Genetics is engaged in the discovery and commercialization of molecular diagnostic tests to determine the risk of developing disease, diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties.