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Health Canada Approves Spartan's Rapid CYP2C19 Test for 'Near Patient' Use

NEW YORK (GenomeWeb) – Health Canada has approved Spartan Bioscience's non-invasive genetic test for determining within an hour whether a person has CYP2C19 genetic mutations.

According to the company, its Spartan RX CYP2C19 System is the "first near-patient DNA test for personalized medicine" approved by health authorities in Canada. The test gauges CYP2C19 mutations, associated with repose to the antiplatelet drug Plavix and a number of other medications, from a cheek swab.

With this approval, Spartan can market the test to doctors, nurses, pharmacists, and lab technicians as a tool to quickly learn patients' genotypes and make treatment decisions in acute care settings. The test is already being used by healthcare professionals at various Canadian hospitals, such as the University of Ottawa Heart Institute, Toronto General Hospital, St. Michael's Hospital, and Sunnybrook Health Service Center, as part of a 5,270-patient clinical trial called TAILOR-PCI.

In that study, being sponsored by the Mayo Clinic's Center for Individualized Medicine, researchers are using the rapid CYP2C19 test to personalize antiplatelet treatments for patients with cardiac stents and track long term outcomes of those with specific mutations.

Health Canada's approval for the test follows the US Food and Drug Administration's 510(k) clearance of the test in August last year. However, in the US, Spartan did not get a point-of-care claim for the rapid test.

"Unlike Spartan's FDA [clearance] in the US, Health Canada's approval allows for near-patient use by frontline healthcare workers such as doctors, nurses, and pharmacists," Spartan CEO Paul Lem told GenomeWeb Daily News in an email. "This means that our test may be performed in Canadian pharmacies and doctors' offices, in addition to hospitals and labs." The Spartan RX CYP2C19 System also has a CE-IVD mark in Europe.