Health Canada approves first near-patient DNA test for personalized medicine

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Spartan Bioscience’s rapid genetic test detects CYP2C19 mutations that impact the effectiveness of widely-used drugs such as Plavix®, Inderal®, Celexa®, and Losec®

Spartan RX: On-demand DNA testing

As a Canadian company, we are proud that our rapid DNA testing technology has the potential to improve healthcare for millions of Canadians.-Paul Lem, M.D., CEO of Spartan Bioscience

Spartan Bioscience announced today that Health Canada has approved the Spartan RX CYP2C19 System. It detects CYP2C19 genetic mutations in less than 60 minutes from a non-invasive cheek swab.

The Spartan RX CYP2C19 System is the first near-patient DNA test for personalized medicine that has been approved in Canada. Due to the system’s ease of use, Health Canada has determined that it may be used by healthcare professionals such as doctors, nurses, pharmacists, and laboratory technicians, in medical care sites and clinical laboratories.

Leading Canadian hospitals such as the University of Ottawa Heart Institute, Toronto General Hospital, St. Michael’s Hospital, and Sunnybrook Health Services Center are already using the system as part of a landmark 5,270-patient clinical trial called “TAILOR-PCI”. The trial is using Spartan Bioscience’s rapid genetic test to personalize antiplatelet drug therapy for heart attack patients with cardiac stents. Genetic carriers are being switched from Plavix® (clopidogrel) to alternative drugs that are not affected by CYP2C19 genetic mutations. Plavix® is one of the best-selling drugs in the world, with over $9 billion in revenues in 2009. The trial is sponsored by the Center for Individualized Medicine at Mayo Clinic in the United States.

Health Canada approval is the most recent regulatory approval for the Spartan RX CYP2C19 System. It adds to existing regulatory approvals such as FDA 510(k) clearance in the United States and CE IVD Mark in Europe.

“The Spartan RX CYP2C19 System helps doctors treat patients faster with the most effective drugs,” said Paul Lem, M.D., CEO of Spartan Bioscience. “As a Canadian company, we are proud that our rapid DNA testing technology has the potential to improve healthcare for millions of Canadians.”

About CYP2C19
The CYP2C19 enzyme metabolizes approximately 15 percent of all prescribed drugs, including important drug classes such as antiplatelet therapies, beta blockers, antidepressants, proton pump inhibitors, and anti-epileptics.(1) About 30% of Caucasians, and more than 50% of Asians and East Indians, carry CYP2C19 gene variants that reduce response to drugs metabolized by CYP2C19.(2,3,4,5) These include widely-used drugs such as Plavix®, Inderal®, Celexa®, and Losec®.

About Spartan Bioscience
Spartan Bioscience is the leader in on-demand DNA testing.(6) Spartan is bringing complete sample-to-result DNA testing systems to medicine. Spartan’s technology fully integrates DNA collection, extraction, and analysis, with an intuitive interface that is easy to operate. In the same way that mainframe computers gave way to personal computers, high-throughput DNA testing systems in central labs are giving way to decentralized devices. For the first time, healthcare providers and their patients can get DNA results on demand. For more information, please visit our website at: http://www.spartanbio.com.

The Spartan logo is a registered trademark of Spartan Bioscience Inc.
Plavix is a registered trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals
Inderal and Losec are registered trademarks of AstraZeneca
Celexa is a registered trademark of Forest Pharmaceuticals

1. dbSNP Short Genetic Variations. Reference SNP (refSNP) Cluster Report: rs12248560
2. Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–11.
3. Chen M et al. (2011). Atherosclerosis. 220(1):168–71.
4. Oh IY et al. (2012). Heart. 98(2):139–44.
5. Jose R et al. (2004). Fundamental & Clinical Pharmacology. 19(1): 101–105.
6. Roberts JD et al. (2012). Lancet. 379:1705–11.

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Kira Watson
Spartan Bioscience Inc.
+1 613-228-7756 Ext: 708
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