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GenMark Expects Launch of Automated Instrument to Greatly Expand Market for Its Multiplex Assays

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GenMark is anticipating that the launch of its new, sample-to-answer multiplex testing instrument later this year will allow it to pursue a greater share of the global molecular diagnostics market by targeting labs without the sample preparation capabilities necessary to use its current platform.

In a presentation at the JP Morgan Healthcare conference in San Francisco last week, GenMark's President and CEO Hany Massarany told investors that the company's current eSensor XT-8 system targets the "top 1,200 or so labs in the US … able to do sample extraction and amplification — the pre-analytical sample preparation required for molecular testing."

With the company's upcoming next-gen system, which it debuted as a prototype at last year's annual meeting of the Association for Molecular Pathology, Massarany said GenMark will be able to "decentralize and expand" that market "to 5,000-plus labs."

According to Massarany, the company received "very positive feedback from customers and investors" on the new system prototype at the AMP meeting.

GenMark's current XT-8 system allows multiplexing of up to 72 molecular targets on a single cartridge and relies on DNA hybridization and electrochemical detection on the company's eSensor cartridges to produce results.

The next-generation instrument will integrate preparation steps including extraction and amplification using digital microfluidics, as well as the company's electronic detection system, into a single end-to-end machine.

"The goal here is to address a significant unmet need for sample-to-answer testing in multiplex analysis," Massarany said in his presentation, which was webcast.

According to Massarany, GenMark is also planning to develop a "roadmap" of new assays alongside the next-gen platform.

Last year the company received approval from the US Food and Drug Administration for its respiratory virus panel, which covers 14 virus types and subtypes. The RSV assay joins three others — for cystic fibrosis, warfarin sensitivity, and risk of thrombophilia — that are FDA approved.

In addition, the company offers several other tests as research-use-only products, including two hepatitis C genotyping panels, a CYP2C19 test, and a 3A4/3A5 genotyping assay.

Last year, Massarany said the company was also working on a KRAS test, which it hoped to release by the end of 2012. He did not mention any progress on that assay in his JP Morgan presentation.

Massarany did say that the company's assay development plans, moving forward with the new automated system, will be focused initially on infectious diseases, but will also include work on low-plex, simpler tests covering disease areas for which testing options are currently limited in the type of labs that the company is targeting for the automated system.

Massarany said GenMark plans to combine these tests "to allow customers to do complex tests together with some simpler high-volume tests that they are already doing in their labs today."

In his presentation, Massarany said he thinks it is "pretty clear" that single-target testing "will soon be a thing of the past."

He cited GenMark's HCV genotyping assay and new RSV panel as examples of the advantages of multiplex testing.

For HCV genotyping, "we know now from early clinical studies that knowing a patient's genotype is important in stratifying them for the best therapy," he said. "And our multiplex test detects all relevant genotypes and subtypes on the same cartridge."

"The respiratory virus panel also provides very important information relevant for critically ill hospital patients with flu-like symptoms," he said. "It's very important to understand the virus that's causing the infection so that the right decisions can be made in treatment. Our panel provides all the relevant viral infections that clinicians want to know about in these cases."

Massarany argued that GenMark's detection technology differentiates it from other multiplex systems.

"Unlike optical detection technologies, we don't have to deal with light so we don’t have interference and background issues," he said.

"We can detect up to 72 targets at once based on the current configuration of the chip," he added, "while with optical, at three, four, five targets you start dealing with interference and background."

"We also don’t have complexities required for optical detection — no lasers, cameras, no washing or moving parts — so we have simplicity that lends itself to decentralizing this area of testing to smaller labs, and to driving costs down."

Massarany said GenMark had 255 systems installed by the end of the company's third quarter last year, and saw its annuity revenue per installed system grow to $90,000.

He cited the company's pursuit of larger customers with bigger testing volumes, as well as growth in its menu of tests, as drivers for this.

"Customers start with one test, like the system, and want to add more," he said.

Additionally, he said, the company has priced some "higher value products" like the RSV and hepatitis C genotyping assays "at a premium" compared to its earlier tests.

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