Millions of Koreans carry CYP2C19 genetic mutations, and the Spartan RX CY2C19 System helps doctors treat them with the most effective drugs.-Paul Lem, M.D., CEO of Spartan Bioscience
Ottawa, Ontario (PRWEB) November 27, 2014
Spartan Bioscience today announced that it has received South Korean Ministry of Food and Drug Safety (MFDS) regulatory approval for its Spartan RX CYP2C19 System. The system provides genetic 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*2 mutation is carried by approximately 50% of Koreans.(1) Leading Korean institutions such as Chonnam National University Hospital, Chung-Ang University Hospital, and Konyang University College of Medicine are already using the Spartan RX CYP2C19 System as part of a landmark clinical trial called TAILOR-PCI. The 5,270-patient trial is sponsored by Mayo Clinic, and is investigating the effectiveness of personalized medicine for heart attack patients.
As part of its regulatory approval, the Spartan RX CYP2C19 System received a favorable new Health Technology Assessment (nHTA) by the National Evidence-based healthcare Collaborating Agency (NECA). The purpose of the assessment is to systematically review the scientific evidence regarding the safety and effectiveness of new products.
Korean MFDS 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, CE IVD Mark in Europe, and Health Canada approval.
The company also announced a partnership with Milestone Bio of Seoul, which will distribute Spartan’s system and test kits in the Korean healthcare market.
“We are pleased and excited that the Spartan RX CYP2C19 System has received Korean regulatory approval. This approval represents a major milestone for our international business,” said Paul Lem, M.D., CEO of Spartan Bioscience. “Millions of Koreans carry CYP2C19 genetic mutations, and the Spartan RX CY2C19 System helps doctors treat them with the most effective drugs.”
The CYP2C19 enzyme metabolizes approximately 15 percent of all prescribed drugs(2), 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.(1,3,4,5,6)
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.
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
1. Jeong YH et al. (2011). Circ Cardiovasc Interv. 4(6):585–594.
2. dbSNP Short Genetic Variations. Reference SNP (refSNP) Cluster Report: rs12248560
3. Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–11.
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.