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JP Morgan Healthcare Conference: MDx Firms See Major Launches in '10-'11

SAN FRANCISCO (GenomeWeb News) - Several molecular diagnostic firms are looking to unveil new assays and instrument systems that could greatly expand their market presence, company executives told investors at the JP Morgan Healthcare Conference held here this week.

Qiagen, which currently has a molecular diagnostic assay portfolio of around 120 tests, is planning to launch new instruments over the next couple of years targeting the entire molecular diagnostics market, from point of care to high-throughput labs.

The firm will soon be rolling out in Europe its QIAensemble high-throughput system, which will have assays for human papillomavirus, chlamydia, gonorrhea, and others. Qiagen hopes that following a 2010 launch in Europe, the system will make its way to the US market in 2012, according to a presentation given by CEO Peer Schatz on Wednesday.

The firm also is targeting the pharmacogenomics market with the launch of the QIAsymphony platform in Europe this year followed by the US in 2011. Schatz said that the company has more than 15 partnerships with pharmaceutical firms to develop pharmacogenomic or companion diagnostic assays. Among those partners are Amgen, Eli Lilly, Merck, ImClone, Boehringer Ingelheim, and Bristol-Myers Squibb.

He said Qiagen intends to file pre-market applications for its KRAS test, for which it has partnered with Amgen, and its EGFR test, in the next two years. Other PGx assays are planned for 2011 to 2014.

Schatz said that when the QIAsymphony is launched it will mark the largest molecular diagnostic offering in the world.

While the firm recently raised its profile in the personalized diagnostics field through its acquisition of DxS, Schatz told GenomeWeb Daily News that Qiagen already does around $50 million in business in the field, and has many partnerships with pharma firms that have not been publicly disclosed.

Also on the way from Qiagen is a point-of-care, portable molecular diagnostics instrument capable of running eight samples at a time. The small machine weighs only half a pound and can run on 3 AA batteries. Schatz said that the instrument would first be deployed in applied markets, with acute care and mobile care being key markets as well. In addition, he said that developing tests for healthcare-associated infections for the instrument are an option.

The instrument was acquired along with its maker, Germany's ESE, a privately held developer and manufacturer of UV and fluorescence optical measurement devices, for $19 million in cash this week.

Overall, the next 12 to 18 months are going to be a "big submission window" as far as regulatory filings go, Schatz told GWDN.

Cepheid

Another firm that is looking to broaden its assay menu is Cepheid, which has been known primarily for its portfolio of HAI tests. John Bishop, the firm's CEO, told investors today that the company's 2010 milestones include the clearance and launch of six tests, two of which — one for flu, and one for VanA, an antimicrobial resistance gene most commonly associated with vancomycin-resistant enterococci — have already been cleared for marketing.

The firm has introductions planned for an MRSA/SA nasal test, a Flu A/B panel, a C. difficile/Epi test, and is targeting the European release of a chlamydia/gonorrhea test this year.

Unlike Qiagen, Bishop believes the company's strategy of trying to serve the market with one scalable platform from low- to high-throughput is an advantage. According to Bishop, labs want to consolidate on a few platforms with a wide menu offered for those systems.

He also said that the firm's newest platform, the Infinity 48, is one or two generations ahead of competitors.

Also new for Cepheid is a development program for a microRNA-based test for lung cancer. Bishop believes that it is possible that the potential test, which he hopes will be based on multiple markers, will eliminate the need for biopsies, as the key marker in development has been detected in serum in both early- and late-stage lung cancers.

Gen-Probe

Gen-Probe will launch its new molecular diagnostics instrument, called Panther, this year, President and CEO Carl Hull said at the conference on Wednesday. The new system will target low-to-mid-volume labs. It will be fully automated, have a smaller footprint, and offer random access testing of qualitative and quantitative assays, which Hull said will enable molecular diagnostic testing capabilities not currently available on its Tigris system.

Assays that run on Panther initially will be similar to the ones on Tigris for chlamydia and gonorrhea. There also are plans for a human papillomavirus assay and its Progensa PCA3 assay to help physicians identify men at risk of increased risk of prostate cancer.

Among the firm's 2010 priorities is to launch Panther in Europe, with a US launch planned for four or five quarters later. Gen-Probe also plans to file for FDA clearance of its Aptima HPV for the Tigris system and an Aptima trichomonas assay for identifying the STD trichomoniasis. It also will continue developing Panther for blood screening, with funding for that project coming from its partner Novartis.

Hull also fired a shot across the bow of other molecular diagnostic firms, saying that the firm's Tigris system has attracted "imitators," and saying that companies "need to be mindful" of Gen-Probe's patent estate. He suggested that the company could license IP to some parties, but would not comment on whether the firm would be pursuing legal action against any competitors in the near future.

Celera

Celera CEO Kathy Ordonez told investors that the company is in the midst of hiring 23 new sales representatives to detail its genetic tests. Thus far, it has hired 17 of those reps.

The firm is trying to expand the market for its KIF6 test, which tests for cardiovascular risk and statin benefit and is currently offered through Celera's Berkeley Heart Labs business. Among those efforts is a collaboration with Medco to study the ability of KIF6 testing to help in getting patients to take their statins. Earlier this week, the firm also licensed rights to the University of California, San Francisco to develop an in-house test for the gene.

Ordonez also said that the firm is discussing with the US Food and Drug Administration the filing of a pre-market approval application for the KIF6 test. The company expects to submit that application in the second half of 2010.

Luminex

Luminex President and CEO Patrick Balthrop noted that the firm expects full-year 2009 revenues of between $119 million and $121 million, revised from its projected revenue guidance in November of between $118 and $126 million.

He also told investors that the firm is aiming to introduce several new products in 2010, including its RVP Fast testing panel, which has been launched in Europe but will be filed for clearance in the US soon. Its test pipeline includes ag/bio and gastrointestinal panels that the firm hopes to launch in 2010.

Luminex also intends to launch its MagPix instrument platform in the second half of the year, expanding the firm's reach into the low-throughput market, said Balthrop. In late 2008, Luminex launched its FlexMAP 3D, a higher-throughput, higher-cost system aimed at larger labs.

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