Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with Lynparza – a breast cancer drug marketed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK).
Lynparza is a PARP inhibitor designed to target deficiencies in DNA damage response pathways. AstraZeneca and Merck are working to get the drug cleared in Japan to treat patients with BRCA-mutated metastatic breast cancer. Myriad’s Bracanalysis test is the first test approved in Japan for use with a PARP inhibitor, the company touted.
In the U.S., the FDA first approved Myriad’s diagnostic, marketed as Bracanalysis CDx, in Dec. of 2014 for patients with advanced ovarian cancer. Myriad snagged another indication earlier this year for patients with HER2-negative metastatic breast cancer.
The diagnostic test categorizes a patient’s DNA sequence variations in the BRCA1 and BRCA2 genes into five classes, according to Myriad: deleterious, suspected deleterious, variant of uncertain significance, favor polymorphism or polymorphism. Those results are sent to medical personnel to decide if the patient is eligible for treatment with a companion drug.
Myriad and AstraZeneca inked a partnership in 2007 to develop a companion diagnostic for Lynparza.
“Our long-standing collaboration with Myriad Genetics Inc. has now delivered an innovative companion diagnostic to breast cancer patients in Japan, demonstrating our shared ambition to target precision medicines to the right patients across the globe,” Dr. Ruth March, AstraZeneca’s senior VP & head of precision medicine & genomics, said in prepared remarks.
“Receiving regulatory approval in Japan is a major milestone for the company and reflects the high quality standards inherent in all of our laboratory tests,” Gary King, EVP of international operations, added. “As the only approved test in Japan, we will collaborate with our commercial partners to ensure patients with metastatic breast cancer have broad access to Bracanalysis and Lynparza, once it is approved.”
Myriad estimates there are 40,000 patients with metastatic disease in Japan that would be eligible for testing with its Bracanalysis system. The company plans to commercialize the test in an exclusive deal with SRL Inc., one of the largest lab service providers in Japan.
“Breast cancer doctors in Japan can offer BRACAnalysis to their patients with metastatic breast cancer to determine if the carry germline BRCA1 or BRCA2 gene mutations,” Dr. Johnathan Lancaster, gynecological oncologist & Myriad’s CMO, said. “Importantly, patients who are found to carry a BRCA mutation could soon be considered for treatment with Lynparza.”
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