Spartan Bioscience Announces Medical Device Registration of Rapid CYP2C19 Testing System in Singapore
Ottawa, Ontario (PRWEB) March 17, 2016 -- Spartan Bioscience today announced that its rapid CYP2C19 genetic testing system is registered with the Health Sciences Authority (HSA) of Singapore. This registration enables commercial sales in the country.
The Spartan RX CYP2C19 System provides CYP2C19 test results in less than 60 minutes from a non-invasive cheek swab. The automated system is indicated as an aid for doctors to determine therapeutic strategies for drugs metabolized by the CYP450 2C19 genetic pathway. These include some of the world’s most commonly prescribed drugs such as Plavix® (clopidogrel), Inderal® (propranolol), Celexa® (citalopram), Vfend® (voriconazole), and Losec® (omeprazole). The CYP2C19 test is particularly relevant to Singaporeans because the CYP2C19*2 mutation is carried by approximately 50% of Asians.(1,2)
Singapore HSA registration 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, CE IVD Mark in Europe, and Health Canada approval.
Spartan Bioscience also announced a partnership with Biomed Diagnostics of Singapore, which will distribute Spartan’s system and test kits in the Singaporean healthcare market.
“We are pleased and excited that the Spartan RX CYP2C19 System is registered in Singapore,” said Paul Lem, M.D., CEO of Spartan Bioscience. “Millions of Singaporeans carry CYP2C19 genetic mutations, and the Spartan RX CY2C19 System helps doctors treat them with the most effective drugs.”
About CYP2C19
The CYP2C19 enzyme metabolizes approximately 15 percent of all prescribed drugs(3), including important drug classes such as antiplatelet therapies, beta blockers, antidepressants, proton pump inhibitors, and anti-epileptics. About 30% of Caucasians, and more than 50% of Asians and Indians carry CYP2C19 gene variants that reduce response to drugs metabolized by CYP2C19.(1,2,4,5)
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. 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
Vfend is a registered trademark of Pfizer
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2. Oh IY et al. (2012). Heart. 98(2):139–44.
3. dbSNP Short Genetic Variations. Reference SNP (refSNP) Cluster Report: rs12248560
4. Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–11.
5. Jose R et al. (2004). Fundamental & Clinical Pharmacology. 19(1): 101–105.
6. Roberts JD et al. (2012). Lancet. 379:1705–11.
Kira Watson, Spartan Bioscience Inc., http://www.spartanbio.com, +1 (613) 228-7756 Ext: 708, [email protected]
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