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JP Morgan Healthcare Conference, Day 4: Cepheid, Fluidigm

SAN FRANCISCO (GenomeWeb News) – The JP Morgan Healthcare Conference wrapped up on Thursday with a handful of life science tools and molecular diagnostics companies presenting to investors, including Sequenom, which spoke about its goal to bill 25,000 MaterniT21 tests in 2012.

Below are capsules of presentations from two other companies that presented on the fourth day of the conference.

Cepheid

Calling Cepheid the market leader in molecular testing of Clostridium difficile and methicillin-resistant Staphylococcus aureus, a key launch for the firm in 2012 will be the introduction of a test for chlamydia and gonorrhea, CFO Andrew Miller said.

The test is currently in clinical trials with an anticipated launch date in Europe during the first half of the year, followed by its introduction in the US in the second half of the year. He added that a CLIA waiver for the test is anticipated in the mid-2013 to 2014 time frame.

In the US alone between 25 million and 30 million chlamydia/gonorrhea tests are performed annually with hospital testing, which would be Cepheid's main target, accounting for about 30 percent of the total volume. The test will be priced competitively with current tests that hospitals have to send out to labs for results, Miller said.

Further out, Cepheid plans to launch a test for HIV in 2013 or 2014. The company's molecular test for tuberculosis has the endorsement of the World Health Organization, and the HIV test would complement that test since many HIV patients also develop TB, Miller said.

Also during 2013 and 2014, the company expects to launch tests for human papillomavirus, hepatitis C, and others, as CE-marked tests.

Last week, Cepheid issued a Class III recall of its blood culture-based Xpert MRSA/SA BC test. During a breakout session, Miller said that the test is a "very, very low" revenue test for Cepheid and is not expected to have a material impact on 2012 results.

Cepheid's flagship nasal swab MRSA test is not affected by the recall.

The recall was generated after a specific group of customers got a high rate of indeterminate results on two specific lots. Cepheid has stopped shipping the test.

Miller said that the firm expects it will have to bring the test back to the US Food and Drug Administration for re-approval and anticipates putting the test back on the market by the end of the year.

Fluidigm

President and CEO Gajus Worthington said in his presentation that growth drivers for the coming year will be anchored by new product introductions.

While he declined to provide details, he said that the products will be in the areas of new assay content, new reagents, and single-cell genomic sample preparation. On the last point, the company has cited it as a key to continued uptake of the firm's instruments, and Worthington said Thursday that "single-cell genomics will be a big market, and Fluidigm will be a leader."

Beyond 2013, he said that Fluidigm is eyeing new market segments including cell culture, molecular diagnostics, and protein expression.

He added that the company is "quite interested" in acquisitions that would complement Fluidigm's portfolio and noted reagents and content companies that already participate in Fluidigm's existing workflows.

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