BRACAnalysis CDx test
On October 18, 2017, Myriad Genetics (MYGN) announced the U.S. Food and Drug Administration’s (or FDA) acceptance of its supplementary premarket approval (or sPMA) application for BRACAnalysis CDx, a DNA sequencing companion diagnostic test to be used with AstraZeneca’s (AZN) Lynparza (olaparib). This test will help in identifying HER2-negative metastatic breast cancer patients who have BRCA mutations and stand to benefit from poly ADP ribose polymerase (or PARP) inhibitor therapy. The company expects approval for this test by the third quarter of fiscal 2018.
If approved, the BRACAnalysis CDx test is expected to be the first and only FDA approved companion diagnostic test for this indication. AstraZeneca has already managed to demonstrate a 42% reduction in risk of disease progression or death in BRCA-mutated, HER2-negative metastatic breast cancer with Lynparza as compared to standard therapy in the OlympiAD trial. Thus, on approval, BRACAnalysis CDx could benefit up to 125,000 patients almost immediately, while 60,000 patients will continue to qualify for this companion diagnostic test on a yearly basis. Notably, Myriad Genetics makes up about 0.59% of the iShares S&P Small-Cap 600 Value ETF’s (IJS) total portfolio holdings.
Companion diagnostics market opportunity
The above diagram shows that Myriad Genetics is targeting the companion diagnostics for DNA-damaging agents market that is estimated to account for global spending of $6.0 billion from 2016 to 2020. Companion diagnostic tests are expected to benefit around 1.4 million people in the US, the EU6, and Canada by 2020.
On June 22, 2017, the FDA approved Thermo Fisher Scientific’s (TMO) next-generation sequencing (NGS) test, a companion diagnostic test that can be used with three FDA-approved therapies in non-small cell lung cancer (or NSCLC) indications. On June 1, 2017, Roche Holdings (RHHBY) also announced FDA approval for a companion diagnostic test to identify anaplastic lymphoma kinase (or ALK) positive NSCLC patients who can be treated with Novartis’s ZYKADIA.
In the next article, we’ll discuss approved indications of BRACAnalysis CDx Test in greater detail.