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GenMark Dx Says Platform Selected for Use in Warfarin Clinical Trial

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This article has been updated from a previous version to reflect the fact that Iverson has not yet finalized its contract with GenMark.

GenMark Diagnostics said this week that its PCR-based eSensor warfarin sensitivity test panel has been selected for use in a clinical trial to assess the impact of genotype on the occurrence of adverse events during warfarin drug therapy.

The trial, named the "Warfarin Adverse Event Reduction for Adults Receiving Genetic Testing at Therapy Initiation," is sponsored by Iverson Genetic Diagnostics, was approved in July by the Centers for Medicare and Medicaid Services, which will reimburse patients for their test costs.

A spokesperson from Iverson, however, told PCR Insider that the company is still finalizing the contract with GenMark.

The specific CMS approval is for a clinical study under coverage with evidence development and will cover pharmacogenetic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness, Iverson said in July.

The study is being led by Elizabeth Ofili, chief of cardiology at Morehouse School of Medicine in Atlanta, Ga., and involves more than 7,000 patients from more than 50 sites nationwide.

The CMS hadn't traditionally reimbursed patients for warfaring testing, "but now there are several trials under way, and it's a step in the right direction," GenMark Founder and CSO Faiz Kayyem told PCR Insider this week.

Iverson CEO Dean Sproles said in a statement that the company selected GenMark's test, which runs on its eSensor XT-8 instrument system, "for its ability to provide accurate and reliable results" and its "fast processing and simple interpretation of patient results."

Genmark, formerly known as Osmetech before an IPO and name change this past spring, received 510(k) clearance for the eSensor test and XT-8 platform in 2008.

According to the company's website, the eSensor XT-8 workflow comprises extracting DNA from patient samples, amplifying target DNA using PCR, performing an exonuclease reaction to create single-stranded DNA, and performing multiplexed detection and analysis on the XT-8 instrument.

GenMark said that the system features a compact design and self-contained, disposable test cartridges, and is designed to support a broad range of molecular diagnostic tests.

Besides the test for warfarin, GenMark has also developed cystic fibrosis genotyping and thrombophilia risk tests for the platform.

Last month, GenMark said that its revenues for the second quarter — its first quarter since going public — grew 162 percent year over year driven by reagent and test revenues and stronger than expected placements of the XT-8 system.

It is unclear how many XT-8 systems GenMark would be used in the Iverson warfarin trial. Officials said that they could not disclose that information because of GenMark's status as a publicly traded company on Nasdaq.

However, Kayyem pointed out that GenMark has also benefitted from the XT-8 platform being selected for use last year in the Clarification of Optimal Anticoagulation through Genetics Trial, a warfarin sensitivity clinical trial sponsored by the National Heart, Lung, and Blood Institute of the National Institutes of Health.

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