Spartan Bioscience Achieves ISO 13485 Certification for Manufacturing of Rapid DNA Testing System

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Important step toward bringing rapid DNA testing to doctors and patients

Spartan RX: Point-of-care DNA testing

Spartan Bioscience, the leader in on-demand DNA testing, today announced that it has achieved ISO 13485 certification for its quality management system. ISO 13485 is an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices.

ISO certification is often considered a first step toward complying with FDA regulatory requirements for a device to be cleared for use in the clinic. Spartan Bioscience is working towards FDA 510(k) clearance in the United States for the Spartan RX CYP2C19—a rapid sample-to-result DNA testing system. The system has already received CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark.

This ISO 13485 certification covers Spartan Bioscience’s R&D and manufacturing facilities in Ottawa, Canada. The achievement of ISO certification offers customers and suppliers an additional level of confidence in the quality and reliability of Spartan Bioscience’s products, as well as the company's commitment to continuous improvement.

“Achieving ISO 13485 certification is a major milestone for Spartan,” said Paul Lem, M.D., CEO of Spartan Bioscience. “It is an important step toward bringing rapid DNA testing to doctors and patients.”

About CYP2C19

The CYP2C19 enzyme metabolizes approximately 15 percent of all prescribed drugs, including important drug classes such as anti-platelet therapies, beta blockers, anti-depressants, proton pump inhibitors, and anti-epileptics.(1) About 30 percent of Caucasians, 40 percent of Africans, and more than 50 percent of Asians and Indians carry CYP2C19 gene variants that reduce response to drugs metabolized by CYP2C19.(2,3,4,5) The CYP2C19*2 and *3 variants account for the majority of reduced drug metabolism. The CYP2C19*17 variant is associated with increased drug metabolism.

About Spartan Bioscience

Spartan Bioscience is the leader in on-demand DNA testing. 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. 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.

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.

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Paul Lem, M.D.
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