Myriad Genetics, Inc., a leader in molecular diagnostics and personalized medicine, announced that it will submit its BRACAnalysis CDx test for approval by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in parallel with the PMDA review of AstraZeneca’s novel PARP inhibitor, olaparib.
BRACAnalysis CDx is the leading genetic test to identify patients who are likely to benefit from treatment with olaparib, which is a novel PARP inhibitor that targets tumor DNA repair pathway deficiencies to preferentially kill cancer cells.
"BRACAnalysis CDx launched precision medicine for ovarian cancer patients by identifying patients more likely to respond to PARP inhibitors," said Mark C. Capone, president and CEO, Myriad Genetics. "As a global leader in personalized medicine, Myriad is committed to providing the highest quality molecular tests in the fight against the world's most challenging diseases, including breast and ovarian cancers."
This announcement builds on a long-term companion diagnostic collaboration with AstraZeneca that began in 2007. In December 2014, the US Food and Drug Administration (FDA) approved BRACAnalysis CDx to identify ovarian cancer patients who may be appropriate for treatment with Lynparza (olaparib). It was the first time the FDA had approved a laboratory developed test (LDT) under the premarket approval application process.
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. It is approved for use as a companion diagnostic with AstraZeneca’s Lynparza (olaparib) for patients with advanced ovarian cancer in the United States and Europe.
Olaparib is the first in a class of drugs that act as inhibitors of poly(ADP)-ribose polymerase (PARP), which exploit tumor DNA repair pathway deficiencies to preferentially kill cancer cells. It is marketed in the United States and Europe under the brand name Lynparza for patients with advanced ovarian cancer.