Myriad Genetics said today that its BRACAnalysis Diagnostic System has won a third regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) that will allow physicians to determine which women with breast cancer are at risk of having Hereditary Breast and Ovarian Cancer (HBOC) syndrome—and thus eligible for treatment with Lynparza (olaparib).
BRACAnalysis is designed to classify a patient’s clinically significant variants in the germline BRCA1 and BRCA2 genes. Variants are classified into one of the five categories; “Deleterious,” “Suspected Deleterious,” “Variant of Uncertain Significance,” “Favor Polymorphism,” or “Polymorphism.”
Once classification is completed, BRACAnalysis test results are sent to medical personnel in Japan for determining the eligibility of patients for treatment with Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor that is co-marketed by AstraZeneca and Merck & Co.
MHLW’s latest approval decision allows physicians to use BRACAnalysis to test for BRCA mutations in women with breast cancer who meet the genetic testing guidelines defined by the Japanese Organization of Hereditary Breast and Ovarian Cancer (JOHBOC).
Patients who test positive for a deleterious BRCA mutation will be eligible to receive some form of advanced medical management, such as prophylactic surgery or targeted therapies.
In the U.S., the FDA has approved BRACAnalysis as a companion diagnostic for Lynparza and Pfizer’s marketed PARP inhibitor Talzenna (talazoparib) in breast cancer. The agency has also authorized BRACAnalysis as a CDx for Lynparza and Clovis Oncology’s Rubraca (rucaparib) in ovarian cancer.
In Japan, MHLW first authorized BRACAnalysis in March 2018 as a companion diagnostic for Lynparza in patients with metastatic inoperable or recurrent breast cancer. In February of this year, BRACAnalysis was approved as a companion diagnostic for Lynparza in women with ovarian cancer.
Results are sent to medical personnel in Japan for determining the eligibility of patients for treatment with Lynparza.
“The approval of BRACAnalysis for HBOC risk assessment in Japan is further validation of the quality and utility of our pioneering genetic test,” Gary A. King, executive vice president of International Operations for Myriad, said in a statement. “We look forward to working with our commercial partners in Japan to ensure that BRACAnalysis is available to patients.”
Myriad has signed an exclusive partnership with SRL, a subsidiary of Miraca Group, to commercialize BRACAnalysis in Japan. SRL carries out nearly 400 million tests per year, covering a variety of testing services that include general/emergency testing, esoteric/research testing, companion diagnostics tests, and genomic analysis.