Roche gains FDA sign-off on lung cancer companion Dx

Roche's ($RHHBY) surging diagnostics arm scored a major win this week, gaining FDA approval for what is being billed as the first companion diagnostic meant to detect a specific mutation connected to metastatic non-small cell lung cancer.

The company's Cobas EGFR mutation test is designed to detect certain epidermal growth factor receptor (EGFR) activating mutations. By doing so, it helps to identify patients who will benefit most from Tarceva, a first-line tablet treatment for patients shown to have the EGRF mutations. The drug, marketed by Astellas Pharma and Roche's Genentech, now has FDA approval as a first-line treatment, rather than only for patients for whom initial chemotherapy treatments haven't worked.

Stellar results from Roche's EURTAC study helped the companion diagnostic gain an FDA nod--a move that validates expanded Tarceva approval. That study focused on 174 patients from February 2007 to January 2011, and the Cobas test was used to help identify patients who had the EGFR mutation.

The approval, however, comes as companies such as Boehringer Ingelheim and Qiagen ($QGEN) focus on developing a drug/companion diagnostic for the lung cancer EGFR gene mutation. An FDA decision is expected in July.

Roche's molecular diagnostics arm continues to be a bright spot for the company. Its applied science arm and diabetes products are still in a slump--leading to cutbacks and reorganization--but its molecular diagnostics side is doing quite well. That area of Roche's business saw sales soar 7% in 2012. And while 2013 first quarter revenue grew at a slower rate, the sector is still going gangbusters for the company overall.

- read the release
- here's Reuters' take

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