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GenMark Expects to File Respiratory Virus, CYP2C19 Tests with FDA in 2012

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By Justin Petrone

Two additional GenMark Diagnostics test panels may be available for clinical use in the US next year, CEO Hany Massarany said last week.

Massarany said that the Carlsbad, Calif.-based molecular-diagnostics firm is on track to submit its respiratory virus panel to the US Food and Drug Administration for 510(k) clearance before the end of the year. The panel allows users to test samples for the presence of 21 upper respiratory viruses.

GenMark is "currently completing the final phase of our expanded clinical trial" and expects regulatory clearance "before next year's flu season," he said. "We expect significant revenue growth from RVP [sales] in 2012."

Additionally, the firm could submit its CYP2C19 genotyping test for FDA clearance in the first half of 2012. The assay, which is currently available for research use only, interrogates 11 alleles to identify patients most likely to respond safely to the anticoagulant Plavix (clopidogrel).

Massarany commented on the new tests during the company's third-quarter conference call, during which he noted that total revenue spiked 92 percent year over year.

If the two new assays are cleared, GenMark will have five clinical tests on the US market. The company's menu currently comprises a cystic fibrosis genotyping test, a thrombophilia-risk test, and a warfarin-sensitivity test.

All of the panels run on GenMark's eSensor XT-8 System, which relies on DNA hybridization and electrochemical detection on the company's eSensor cartridges to produce results.

The two new tests will face competition. Rivals for the respiratory virus panel could include Tessarae's Affymetrix-manufactured RPM-Flu array, which received Emergency Use Authorization during last year's flu season. The EUA has since expired.

Another potential rival is Quest Diagnostics' Simplexa Influenza A H1N1 test, which received 510(k) clearance last year but requires its own platform to run the test. Idaho Technology also offers a PCR-based respiratory virus panel that runs on its FilmArray system.

Meantime, the 2C19 assay could see competition from Vista, Calif.-based Autogenomics' FDA-cleared Infiniti CYP2C19 assay, which runs on the firm's BioFilmChip microarray. Another rival could be Roche's Affymetrix-manufactured AmpliChip CYP450 test.

During the call, Massarany also discussed GenMark's hepatitis C genotyping test, recently launched for research use only. He said that the firm also hopes to bring to market next year a "series of tests" that genotype HCV for subtypes linked to drug response. He noted the firm hopes these assays will "round out" the company's HCV franchise in a market valued at $50 million in the US and $100 million globally.

Massarany added that GenMark is also moving ahead with plans to introduce a KRAS mutation test for research use in 2012, for which it may seek premarket approval next year.

Financials

Total revenue for the three months ended Sept. 30 rose 92 percent to $1.3 million from $684,000 a year ago. The top-line growth was driven by product revenue, made up exclusively by reagent sales, which grew 84 percent to $1.2 million from $656,000 a year ago.

During the call, Chief Financial Officer Paul Ross said that the company placed 22 systems in Q3, bringing its installed base to 141. Massarany noted that GenMark installed 59 systems over the past 12 months and expects to place more than 20 additional units by the end of the year.

Massarany also said that GenMark has benefited from investments in sales and marketing activities. The company currently employs 11 sales people and "expects these numbers to increase" in 2012, he said.

GenMark's licensing and other revenues, which include instrument sales, increased to $110,000 from $28,000 a year ago. The company attributed the rise to higher partnering contract revenue.

R&D spending increased 12 percent to $1.9 million from $1.7 million a year ago. Ross attributed the rise to increased spending on the HCV genotyping test and respiratory viral panel.

SG&A costs rose 32 percent to $3.7 million from $2.8 million a year ago.

For the quarter, GenMark's net loss climbed to $6.3 million from $4.9 million during the year-ago period.

The company finished the quarter with $31 million in cash and cash equivalents and $5 million in short-term investments. In June, it raised around $31.7 million in net proceeds from a follow-on equity offering.

Massarany said that the company's automated next-generation eSensor system has been the "major beneficiary" of the funding. GenMark has "completed a technology assessment for integrating sample preparation steps including extraction and amplification with our eSensor detection system on a single sample-to-answer cartridge," he said.

Massarany added that the firm is finalizing deals with development partners and plans to launch the system in late 2013 (BAN 8/9/2011).


Have topics you'd like to see covered in BioArray News? Contact the editor at jpetrone [at] genomeweb [.] com

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