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Spartan Bioscience's CE-Marked CYP2C19 Test Will Also Be Submitted to the FDA

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Originally published Dec. 20.

Spartan Bioscience has garnered a CE IVD Mark in the European Union for its Spartan RX CYP2C19 point-of-care Plavix pharmacogenetics test, the company announced this week.

According to the firm, this certification will allow it to commercially distribute the test in Europe and in countries in the Middle East, Africa, Latin America, and Asia-Pacific that recognize the CE Mark. The test aims to help cardiologists identify patients who have CYP2C19*2 mutations, which have been shown in published studies to impair heart patients' ability to metabolize Bristol-Myers Squibb's antiplatelet drug Plavix.

The inability to metabolize Plavix is particularly risky for CYP2C19*2 carriers undergoing stent procedures, as they have a 42 percent higher risk of death, stroke, or heart attack in the first year after having gotten a cardiac stent compared to non-carriers of the allele.

"Since the CYP2C19*2 mutation is found in up to 30 percent of the world's population, it is imperative for labs around the world to have a point-of-care test that can help identify this mutation," said Spartan Bioscience CEO Larry D'Andrea in a statement. "With the CE IVD Mark certification, European clinicians and cardiologists can now use the proven Spartan RX CYP2C19 to determine their treatment strategy at the onset of heart attacks."

D'Andrea noted that the company validated the accuracy and reliability of the Spartan RX CYP2C19 point-of-care system ahead of getting the CE Mark, and is continuing to study the test for a potential regulatory filing with the US Food and Drug Administration by the third quarter of 2011.

In August, Spartan Bioscience said that its point-of-care CYP2C19 test was being used by researchers at the University of Ottawa Heart Institute as part of a prospective, randomized-controlled trial to gauge CYP2C19 mutations that may impair cardiac patients' response to Plavix. (PGx Reporter 08/11/10).

The study, called Rapid Gene, is investigating whether treatment with Effient, developed by Eli Lilly and Daiichi Sankyo, can reduce cardiac adverse events for CYP2C19*2 carriers who would not respond to Plavix. Data from the Rapid Gene trial will be part of Spartan's submission to regulatory authorities for marketing approval in the US.

Effient and Plavix are competing antiplatelet agents in a market that exceeded $9 billion last year, dominated by Plavix. The race to capture the population most likely to benefit is heating up as Plavix is set to lose patent protection in 2012, and genetic tests are coming to market claiming to distinguish responders from non-responders.

In the University of Ottawa study, "nurses are performing the sample-to-result test at point-of-care in the cardiac catheterization lab," D'Andrea told PGx Reporter this week. "Early results from the trial indicate the system continues to provide excellent accuracy and reliability."

Spartan Bioscience describes its RX CYP2C19 test as "a non-invasive and easy-to-use DNA testing system" that yields genotype results in one hour. This is a significant improvement over clinical tests performed at centralized laboratories, which can have turnaround times of up to seven days.

These lengthy turnaround times limit the clinical utility of existing CYP2C19 tests, since "complications for CYP2C19*2 carriers occur in the first 24 to 48 hours," Spartan Bioscience noted in a statement, citing data from published literature. A point-of-care test is expected to aid cardiologists in determining the right anti-clotting treatment strategy at the time of a patient's heart attack.

Given that the anti-clotting drug market is estimated to reach $12 billion by 2021, there is also a race among diagnostic players to move tests from centralized clinical labs closer to patient care, where rapid access to genetic data can impact patient outcomes.

As such, Nanosphere is also developing an investigational point-of-care CYP219 test on the Verigene platform that is being used by the Center for Thrombosis Research at Sinai Hospital of Baltimore in a study to identify which patients are at risk for a cardiac event after coronary stenting.

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