Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that it has signed a commercialization plan with Pfizer Inc. The plan is under an existing companion diagnostic agreement, in which Myriad is pursuing U.S. Food and Drug Administration (FDA) approval for its BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s investigational PARP (poly ADP ribose polymerase) inhibitor, talazoparib.
Talazoparib and BRACAnalysis CDx currently are under FDA review, with New Drug Application and Supplementary Premarket Approval submissions based on results from the EMBRACA trial, which evaluated talazoparib versus physician’s choice chemotherapy in patients with germline (inherited) BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer
. Myriad anticipates a regulatory decision from the FDA by December 2018.
Under the commercialization plan, each company remains responsible for the commercialization of its respective product. However, the companies will collaborate on certain commercial activities intended to support the use of the BRACAnalysis CDx in identifying patients for potential treatment with talazoparib following FDA approval.
"We believe this commercial collaboration is another strong indication of Myriad’s global leadership in the field of companion diagnostics for PARP inhibitors and personalized medicine," said Lloyd Sanders, president of Myriad Oncology. "We are excited to be working with Pfizer and towards ensuring patients have access to this class of drugs."
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of 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. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located in Salt Lake City, UT.
Myriad focuses on discovering and commercializing molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties