Myriad Genetics ($MYGN) debuted its next-gen molecular diagnostic tool capable of analyzing 25 different genes associated with 8 major cancers. The Salt Lake City company is opting to launch the product with limited access at first, followed by an expanded rollout in the beginning of next year.
The myRisk Hereditary Cancer multi-gene diagnostic test has increased sensitivity to detect cancers including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma. Each test includes a genetic test result, a clinical risk and a healthcare management tool based on professional guidelines, according to the company. The average out-of-pocket cost for patients is less than $100, with about 97% of healthcare plans covering the test, according to a Myriad spokesperson. The cost is comparative to Myriad's BRACAnalysis, which only analyzes two genes.
"We estimate 250 healthcare providers from across the country will be involved with our early-access program," the representative told FierceMedicalDevices in an email. "The goal of this phase of the launch is to ensure that we are responsible and meeting out customers' expectations in terms of accuracy and turnaround time. Also, we want to make sure healthcare providers receive the appropriate training before using this new test."
Myriad is moving forward with BRAC test development even as it continues legal battles concerning other BRCA test issues. Myriad is fighting several suits against competitors Ambry Genetics and Gene by Gene regarding Myriad's patent on BRCA tests, as well as claims by Ambry that Myriad is monopolizing the sector. But the Supreme Court ruled in June that, despite a ban on gene patents, Myriad could hold on to its individual complementary DNA work, which includes its BRCA1 and BRCA2 genes related to breast and ovarian cancer.
Myriad is scheduled to present clinical validity data for the myRisk test at the annual meeting of The Collaborative Group of the Americas on Inherited Colorectal Cancer in October and the San Antonio Breast Cancer Symposium in December.
"We are excited to launch myRisk Hereditary Cancer, which is a significant scientific advancement in hereditary cancer testing for a range of clinically actionable cancers," Myriad President Mark Capone said in a statement. "MyRisk Hereditary Cancer will improve the quality of patient care by empowering healthcare providers with knowledge about their patients' risk of hereditary cancer and the appropriate medical management options available based on that risk."
- here's the release