Roche lung cancer Dx achieves Chinese approval

Roche's ($RHHBY) Ventana Medical Systems arm gained pivotal Chinese regulatory approval for a companion diagnostic that pairs with Pfizer's ($PFE) targeted lung cancer drug Xalkori.

That's a big win, to say the least. China's healthcare market is huge and continues to grow rapidly, despite a recent regulatory crackdown. And emerging economies offer major opportunities for diagnostic, device and drug companies alike. For Roche's diagnostic arm, it adds to the company's continued, rapid development and rollout of companion diagnostic tests.

Based on data involving 1,000 patients in China, the country's Food and Drug Administration approved the Ventana ALK immunohistochemistry assay. It's designed to screen for the anaplastic lymphoma kinase (ALK) fusion protein, whose targeting has helped shrink cancer tumors in patients positive for the gene. Pfizer's Xalkori is also OK'd in China to treat patients with locally advanced or metastatic ALK-positive non-small cell lung cancer, and the test can now be used in tandem to spot non-small cell lung cancer patients who are positive for ALK. During the trial, the test worked on par with an Abbott ($ABT) diagnostic that also goes with Xalkori.

The approval "allows us to offer our customers ALK diagnostic testing in non-small cell lung cancer--one of the most prevalent and deadly cancers in China--as part of our active pursuit of personalized healthcare initiatives through new innovative products," Fatt-Heng Wong, general manager of Roche Diagnostics China, said in a statement.

Roche's Ventana ALK IHC assay now has approval in 53 countries, the company notes. And while its applied science and diabetes products are slumping--the company may be looking to sell its glucose meter business--molecular diagnostics sales are rising steadily.

- read the release

Want more diagnostics coverage? Check out FierceDiagnostics, a weekly roundup of trends, analysis and need-to-know news across the industry. Subscribe

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.