Qiagen TB test gains Chinese regulatory approval

Qiagen ($QGEN) won Chinese regulatory approval for a next-generation tuberculosis test and expects a commercial rollout there in the early part of 2014.

GenomeWeb reported on the news concerning the company's QuantiFeron-TB Gold blood test, which came out during Qiagen's recent analyst day meeting. Qiagen has billed the test as being on track to become its largest product, according to the article.

Qiagen snatched up the technology with its 2011 purchase of Australia's Cellestis. It's had U.S. FDA approval since 2005, and the company has billed the diagnostic as cutting-edge and a big advance for tuberculosis screening, the story noted.

So why is China a big deal? In addition to being the world's most populous nation with a surging, rapidly developing healthcare market, it also offers a profoundly large patient pool that needs the tests. According to GenomeWeb, China is the globe's second biggest market for active TB.

Qiagen is targeting further growth in companion diagnostics partnerships. The company inked its third such deal recently with Eli Lilly ($LLY) to develop a molecular diagnostic test that would screen for ideal patients for one of Lilly's cancer drugs under development. Their ongoing relationship spurred a companion test for colon cancer drug Erbitux, which Lilly co-developed with Bristol-Myers Squibb ($BMY).

As well, Qiagen is developing companion diagnostic tests for companies including Boehringer Ingelheim, Bayer, Pfizer ($PFE) and Amgen ($AMGN).

- read the GenomeWeb story (reg. req.)

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