Biopharmaceutical company Tesaro has signed a companion diagnostic agreement with molecular diagnostic company Myriad Genetics to get a genetic mutation test done in support of its niraparib clinical trials.
As part of the collaboration, Myriad will employ its genetic test called BRACAnalysis as a companion diagnostic on the patients enrolling in two separate Phase III clinical studies with niraparib, which is a new orally active poly (ADP-ribose) polymerase, or PARP, inhibitor.
BRACAnalysis helps in confirming the presence of a BRCA1 or BRCA2 gene mutations that are responsible for the occurrence of majority of hereditary breast and ovarian cancers.
It has been observed that the people with a mutation in either BRCA1 or BRCA2 gene have nearly 87% risk associated with the development of breast cancer, and up to 44% risk is due to the development of the ovarian cancer by 70 years of age.
Myriad Genetics president and CEO Peter Meldrum said, "We believe this agreement reinforces BRACAnalysis as the gold standard companion diagnostic test for this exciting new class of therapeutics."
Out of the two studies, patient enrollment for one Phase III study in platinum sensitive, high grade serous ovarian cancer patients is scheduled in mid-2013, while Phase III study in metastatic breast cancer patients who have germline BRCA mutations will start enrolling in second half of 2013.