Myriad Genetics ($MYGN) won FDA approval for its companion diagnostic test for AstraZeneca's ($AZN) ovarian cancer drug Lynparza, giving the company a boost as it recoups from its latest patent battle loss and helping it gain ground in a fast-growing market.
The company's BRACAnalysis test looks at mutations in BRCA1 and BRCA2 genes in blood samples to identity which patients are the right fit for Lynparza, and it is the first companion diagnostic approved for use with a PARP inhibitor, a first-in-its-class drug that targets cancer cells and leaves a patient's normal cells undamaged. Less than 25% of ovarian cancer patients know their germline BRCA status, which plays a critical role in deciding whether or not a patient should be treated with Lynparza, said Mark Capone, president of Myriad Genetic Laboratories, in a statement.
"Myriad is excited to offer the first and only FDA-approved companion diagnostic for Lynparza, which we believe opens a new door in personalized medicine and represents a big step forward in tailoring treatment for women with ovarian cancer," Capone said.
The FDA reviewed BRACAnalysis under its premarket approval pathway, an accelerated program for high-risk medical devices that treat or diagnose serious diseases or conditions and that have no market precedent, and used data from a clinical study of Lynparza to grant approval for Myriad's companion test.
The regulatory signoff comes at a pivotal moment for Myriad, as it tries to regroup after losing an appeal over its breast cancer DNA tests. Earlier this week, the Salt Lake City, UT-based company suffered a stinging setback in its attempt to keep rival breast cancer diagnostics off the market when a U.S. appeals court ruled that its patents for the products were not eligible for legal protection, clearing the way for competitors. Myraid said it was disappointed in the court's ruling but is staying mum about a potential appeal.
Meanwhile, the company continues to forge ahead with companion diagnostics and beef up its cancer test portfolio. In November, Myriad signed an expanded deal with AbbVie ($ABBV) to use its Tumor BRACAnalysis alongside the drugmaker's veliparib to help detect breast cancer. The company competes with big names like Qiagen ($QGEN) and Foundation Medicine ($FMI), which are hard at work on rival companion diagnostic products.
Myriad is also "actively collaborating" with several biopharmaceutical companies to evaluate its BRACAnalysis companion diagnostic test for use with other cancer drugs, Capone said in a statement.
"Our scientific excellence, reputation for high quality and regulatory experience are key reasons why Myriad is fast becoming the partner of choice for many biopharmaceutical companies seeking to co-develop companion diagnostic tests," he said. "We hope to expand our collaborations and further diversify our product portfolio."
- read Myriad's statement
- here's the FDA announcement