This month, Japan’s Ministry of Health, Labour and Welfare approved the BRACAnalysis® Diagnostic System, also known as the “BRACAnalysis” genetic test, to be used to test which breast cancer patients may benefit most from additional and more specialized treatment. The test, created by U.S. based Myraid, may help deliver necessary treatment options to women who were before over looked.
The recent approval by the Japanese MHLW will now allow physicians to use the test to determine which women with breast cancer have Hereditary Breast and Ovarian Cancer (HBOC) syndrome and qualify for additional medical management. This detection would make patients eligible to receive additional treatment, such as surgery. This is the only test approved in Japan of its type.
Myriad was founded in 1991 and was one of the first genomics companies. In 1994, Myriad published the discovery of the BRCA1 gene in the journal Science, a major step forward in cancer care. A year later, Myriad published the discovery of BRCA2 gene. It was then the company launched its first commercial product, the BRACAnalysis. Myriad was the exclusive provider of these test from 1996 up until 2013 when the supreme court invalidated Myriad's patent on these two genes.
Most cases of breast and ovarian cancers are not related to genetic cause, but for those that are, having these genes can increase one’s risk of eventually developing these cancer. The genes BRACA1 and BRACA 2 can increase this risk by up t0 65 percent percent.
The test were made famous by Angelina Jolie when she went public in 2013 with her decision to undergo a preventative double mastectomy and later an operation to remove her ovaries and fallopian tubes, to lower her risk of developing breast and ovarian cancer.
The test will help deliver treatment to patients who most need it.(Photo by Noam Galai/Getty Images)
The tests have already been approved for use in the U.S. Earlier this year, BRACAnalysis was approved in Japan as a companion diagnostic for Lynparza in women with ovarian cancer, and in 2018 as a companion diagnostic for Lynparza in patients with metastatic inoperable or recurrent breast cancer, a press release read.
BRACAnalysis differ from typical popular genetic testing in that they have to be administered by a doctor. Although at-home tests can detect medical risk, according to Myriad spokesman Ron Rogers, the tests are completely different.
“We’ve sort of lumped those kind of tests into a category that’s called “recreational genomics,” explained Rogers. “Twenty-three and me and Ancestry.com are in that category. Those are sort of fun tests to get back but you wouldn’t want to make any sort of clinical decisions based on those tests.”
The BRACAnalysis Diagnostic System are now available for use in Japan and Myriad has partnered with SRL Inc to commercialize the product.
