Spartan Bioscience Announces Medical Device Registration of Rapid CYP2C19 Testing System in Saudi Arabia

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Sample-to-result system provides CYP2C19 test results in 60 minutes.

Spartan RX CYP2C19 System

We are excited to make personalized medicine a reality in Saudi Arabia.-Paul Lem, M.D., CEO of Spartan Bioscience

Spartan Bioscience today announced that its rapid CYP2C19 testing system is listed in the Medical Device National Registry (MDNR) of the Kingdom of Saudi Arabia (KSA). This registration enables commercial sales in the KSA.

The Spartan RX CYP2C19 System provides CYP2C19 test results in less than 60 minutes from a non-invasive cheek swab. It helps doctors determine therapeutic strategies for drugs metabolized by the CYP450 2C19 genetic pathway, which include anti-platelet therapies, beta blockers and proton pump inhibitors. The sample-to-result system has received FDA 510(k) clearance and Mayo Clinic is using it in a landmark 6,000-patient clinical trial called TAILOR-PCI.

“We are excited to make personalized medicine a reality in Saudi Arabia,” said Paul Lem, M.D., CEO of Spartan Bioscience.

About CYP2C19
The CYP2C19 enzyme metabolizes approximately 15 percent of all prescribed drugs(1), including important drug classes such as anti-platelet therapies, beta blockers, anti-depressants, proton pump inhibitors, and anti-epileptics. About 30% of Caucasians, 30% of Saudi Arabians, and more than 50% of Asians and Indians carry CYP2C19 gene variants that reduce response to drugs metabolized by CYP2C19.(2,3,4,5,6)

About Spartan Bioscience
Spartan Bioscience is the leader in on-demand DNA testing.(7) 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. Goldstein JA et al. (1997). Pharmacogenetics. 7(1): 59–64.
4. Chen M et al. (2011). Atherosclerosis. 220(1):168–71.
5. Oh IY et al. (2012). Heart. 98(2):139–44.
6. Jose R et al. (2004). Fundamental & Clinical Pharmacology. 19(1): 101–105.
7. Roberts JD et al. (2012). Lancet. 379:1705–11.

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Kira Watson
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