Myriad Genetics' Ovarian Cancer Test Wins FDA Approval

Myriad Genetics' Ovarian Cancer Test Wins FDA Approval

Utah-based molecular diagnostics provider Myriad Genetics, Inc. has received the FDA approval for its well acclaimed molecular companion diagnostic test – BracAnalysis CDx.

Myriad Genetics' BracAnalysis CDx has become the first and only FDA-approved test to be permitted for use with AstraZeneca's  latest FDA-cleared ovarian cancer drug – LynParza – for the treatment of women with advanced ovarian cancer.

Myriad's BracAnalysis CDx is a highly accurate molecular companion diagnostic test that can detect the presence of BRCA1 and BRCA2 gene mutations by examining a patient's blood sample. Evidently, through clinical studies, it has been observed that BracAnalysis CDx can effectively recognize patients with BRCA mutations, who can then be treated with Lynparza.

Women with mutations resulting in defective BRCA genes are more likely to contract ovarian cancer. It is estimated that 10–15% of all ovarian cancer cases is associated with hereditary BRCA mutations.

Management at Myriad believes this FDA approval will open up new roads for personalized treatment of ovarian cancer patients who can potentially be treated with a new class of drugs like Lynparza.

At the European Society of Medical Oncology meeting, data presented by Myriad showed that its tumor BracAnalysis CDx can identify approximately 44% more ovarian cancer patients who are likely to respond to olaparib than conventional germline BRAC testing. This has significantly enhanced the potential market for olaparib and the significance of the BracAnalysis CDx test.

However, less than 25% of ovarian cancer patients know their germline BRCA status, the knowledge of which is crucial for treatment with Lynparza. This implies that Myriad's BracAnalysis test has significant untapped opportunity to capitalize on, going ahead.

Currently, Myriad is engaged in active partnership with several biopharmaceutical companies to further evaluate BRACAnalysis CDx as an investigational companion diagnostic for use with other PARP inhibitors and chemotherapeutic agents and for use in many other solid tumor types.

Myriad expects to get a revenue benefit in the second half of fiscal 2015 from BracAnalysis CDx, once Lynparza gets the FDA nod. We believe the aforementioned FDA go-ahead serves as a stepping-stone for the same.