Diagnostic tests provider Myriad Genetics has included a commercialisation plan into its ongoing companion diagnostic agreement with pharmaceutical giant Pfizer.
As part of the existing arrangement, Myriad is seeking the US Food and Drug Administration (FDA) approval for its BRACAnalysis CDx device as a companion diagnostic for Pfizer’s talazoparib therapy.
Under the new plan, each company will be responsible for the commercialisation of its respective product.
However, the companies will partner on select commercial activities associated with the use of BRACAnalysis CDx to detect patients for potential treatment with talazoparib, following the FDA approval.
Myriad Oncology president Lloyd Sanders said: “We believe this commercial collaboration is another strong indication of Myriad’s global leadership in the field of companion diagnostics for PARP inhibitors and personalised medicine.
“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 designed to qualitatively detect and classify variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes.
For the testing, the device uses genomic DNA extracted from whole blood specimens collected in EDTA.
Talazoparib is an investigational, poly ADP ribose polymerase (PARP) inhibitor being developed for the treatment of various cancer types characterised by DNA damage repair (DDR) deficiencies.
Currently, both BRACAnalysis CDx and talazoparib are under the FDA review and a regulatory decision is expected by December this year.
The supplementary premarket approval and new drug application filings of the products are based on data obtained during the EMBRACA clinical trial in patients with germline (inherited) BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.