Myriad Genetics said today that it signed an expanded companion diagnostic agreement with AbbVie to use Tumor BRACAnalysis CDx™ as a companion diagnostic in support of AbbVie’s clinical-phase poly (ADP-ribose) polymerase or PARP inhibitor, veliparib.
Myriad said the collaboration builds upon previous agreements with AbbVie, under which Myriad is providing BRACAnalysis CDx testing to support several of AbbVie’s ongoing Phase III clinical studies of veliparib, including neo-adjuvant and metastatic breast cancer.
“Myriad’s goal is to provide best-in-class patient care, and we believe that Tumor BRACAnalysis CDx will help us deliver on this goal by identifying patients who may respond to breakthrough therapies currently in development,” Peter Meldrum, Myriad’s president and CEO, said in a statement.
Tumor BRACAnalysis CDx is a companion diagnostic designed for identifying both germline (hereditary) and somatic (tumor) cancer-causing mutations in the BRCA1 and BRCA2 genes. According to Myriad, Tumor BRACAnalysis CDx has been shown to identify up to 50% more patients with BRAC 1/2 mutations who may benefit from treatment with PARP inhibitors compared to conventional germline testing alone.
According to AbbVie’s pipeline web page, Veliparib is in Phase III trials for BRCA-deficient breast cancer, neoadjuvant treatment of triple negative breast cancer, and non-small cell lung cancer (NSCLC)—and in Phase II testing for brain metastasis and other cancers.
Myriad said it is actively collaborating with leading pharmaceutical companies to use Tumor BRACAnalysis CDx as a companion diagnostic with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents. Another pharma company partnering with Myriad is AstraZeneca, developer of the PARP inhibitor olaparib.
Last month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended olaparib be approved as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
In the U.S., testing via the Tumor BRACAnalysis CDx will be carried out at Myriad’s lab in Salt Lake City. In Europe, the CE-marked test will be performed at the company’s Munich laboratory, Myriad said last month.