GenMark Diagnostics expects regulatory approval for its respiratory virus panel before the end of 2012 and plans to release a more comprehensive genotyping assay for hepatitis C by the third quarter of this year, as the company looks to expand its menu of array-based diagnostics, CEO Hany Massarany said recently.
While the company is still considering its schedule for additional diagnostics, it also hopes to file for regulatory approval for its CYP2C19 and to release a planned KRAS genotyping assay before the year is out, followed by other undisclosed tests, Massarany said.
As GenMark broadens its menu of tests, which run on the company's eSensor XT-8 system, it expects increased revenue from reagent sales, and has already seen a steady rise in reagent annuities per analyzer over the last year.
During an earnings call last month recapping GenMark's fourth-quarter 2011 earnings, Massarany said the company's recent submission to the US Food and Drug Administration for its respiratory virus panel is making good progress, but explained that GenMark is "still verifying the schedule for [additional] important assays in the context of other menu priorities," suggesting that timelines for the firm's CYP2C19 and KRAS projects might be somewhat delayed from earlier estimates.
GenMark submitted its RVP for FDA 510(k) clearance in December 2011. In the Q4 call, Massarany said the company is still working with the FDA to complete the approval process and expects to receive approval before this year's flu season.
He also said customers using the research-use-only version of the test have been providing "very positive feedback about [its] performance and ease of use."
Massarany said GenMark expects the assay to drive significant revenue in 2012, especially towards the end of the year as flu season progresses. When the RVP is cleared it will be the fourth clinical test in the company's US menu joining tests for cystic fibrosis genotyping, thrombophilia risk, and warfarin sensitivity.
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.
GenMark previously reported that it planned to submit its CYP2C19 genotyping test for FDA clearance in the first half of 2012. The current RUO assay interrogates 11 alleles to identify patients most likely to respond safely to the anticoagulant Plavix (clopidogrel) (BAN 12/15/2011).
Massarany said during the earnings call that the CYP2C19 RUO product has demonstrated "excellent performance and strong acceptance by customers." He said GenMark now plans to begin clinical trials to support an FDA submission during the "back half of 2012."
Regarding the firm's planned KRAS test, Massarany said GenMark is "completing final stages of development" to bring the assay to market later this year. He also said the company is planning to seek regulatory approval for the KRAS assay through an "equivalence study … where you can demonstrate equivalence with an FDA-approved test and thereby gain approval as long as you are prepared to be limited to the same claims."
Massarany suggested GenMark is also considering additional thus-far unnamed assays. "We are reviewing business cases for other new assays in addition to the timing for the KRAS test, and will advise of these when appropriate," he said.
In the meantime, the company will be working to develop and release a more comprehensive version of its existing hepatitis C genotyping assay later this year, Massarany said.
He did not detail whether this would complement or replace the company's current HCV genotyping test, but said that customers have been impressed with the current assay in terms of "sensitivity, specificity, and especially workflow and turnaround time."
GenMark plans to release the newer HCV product by the third quarter of this year as an RUO test, Massarany said. The assay will allow more comprehensive subtyping by interrogating additional sections of the virus, as well as testing directly from blood and plasma, he explained.
Massarany reiterated that the HCV genotyping market is valued at $50 million in the US and $100 million globally. "We believe this franchise will be a significant contributor to our revenue in the future," he said. The company is not planning to submit the more comprehensive HCV for FDA approval this year.
Finally, Massarany said that the company is on track to show a prototype of its sample-to-answer "next-gen" system — an update of the eSensor XT-8 instrument incorporating sample preparation, amplification, and other pre-analytical steps — later this year, and to launch the platform in late 2013.
"With technical feasibility complete, and system development underway, we are very optimistic about showing the system later this year as we prepare for a late 2013 launch," he said.
GenMark's total revenue for the three months ended Dec. 31 rose 150 percent to $2.0 million from $805,000 a year ago, due to strong sales to existing and new customers, expanding both the number of systems in the field and the number of tests sold, Massarany and CFO Paul Ross said during the call.
More specifically, Massarany said that the company placed 26 systems in Q4, bringing its installed base to 167. He noted the 26 placements put the firm "well ahead of [its] original forecast of 15 to20."
Full-year revenue increased 92 percent from $2.6 million in 2010 to over $5 million in 2011, Ross said. The company reported a net loss of $5.4 million compared to a net loss of $3.5 million a year ago.
GenMark finished the quarter with more than $30 million in cash and investments, he said.
Ross said the company intends to continue investing cash in broadening GenMark's product menu, including investing "heavily" in the NextGen platform.
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