Navigation Links
Spartan Bioscience Receives FDA Clearance for First Rapid DNA Test of Mutations Affecting Metabolism of Common Drugs

Ottawa, Ontario (PRWEB) August 27, 2013

Spartan Bioscience today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of the Spartan RX CYP2C19 System. It provides genetic results in less than 60 minutes from a non-invasive cheek swab.

The automated system is indicated as an aid for clinicians to determine therapeutic strategy 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), and Losec® (omeprazole).

The sample-to-result system identifies CYP2C19*2, *3, and *17 variations from a patient’s cheek swab. The system’s ease of use and on-demand processing capability enable hospitals to generate time-critical results.

"The Spartan RX CYP2C19 System helps doctors treat patients faster with the most effective drugs,” said Paul Lem, M.D., CEO of Spartan Bioscience. “FDA clearance is a significant achievement for Spartan Bioscience. There is a tremendous opportunity for rapid DNA testing in the United States.”

About CYP2C19

The CYP2C19 enzyme metabolizes approximately 15 percent of all prescribed drugs, including important drug classes such as anti-platelet therapies (clopidogrel), beta blockers (propranolol), anti-depressants (citalopram), proton pump inhibitors (omeprazole), and anti-epileptics (phenytoin).(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.(6) 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. Stop waiting days to weeks—get results on demand with Spartan. For more information, please visit our website at:

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.

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. First Point-of-Care DNA Test Submitted for FDA Clearance by Spartan Bioscience
2. Spartan Bioscience Announces 6,000-Patient Study of Personalized Medicine for Cardiac Stents
3. Seahorse Bioscience and the Cancer Research UK Beatson Institute Team Up Against Cancer
4. Pressure BioSciences, Inc. to Discuss Second Quarter 2013 Financial Results and Provide a Business Update
5. MD Biosciences Offers IL-23-Induced Psoriasis-Like Preclinical Model for Skin Inflammation
6. Sanguine BioSciences Announces Distribution Partnership with AMS Biotechnology
7. Sangamo BioSciences Announces Presentation At The 2013 Wedbush Life Sciences Management Access Conference
8. Flagship Biosciences Expands Digital Pathology with Pharmaceutical Biostatistics Services
9. Factor Bioscience Granted First U.S. Patent for RNA-Based Reprogramming Technology
10. Oxford University Press to publish BioScience journal starting in 2014
11. Neurocrine Biosciences Reports Second Quarter 2013 Results
Post Your Comments:
(Date:11/24/2015)... FAR HILLS, N.J. (PRWEB) , ... November 24, 2015 , ... ... University, as the recipient of the 2016 USGA Green Section Award. Presented annually since ... of golf through his or her work with turfgrass. , Clarke, of ...
(Date:11/24/2015)... ... November 24, 2015 , ... Copper is an essential ... bound to proteins, copper is also toxic to cells. With a $1.3 million ... (WPI) will conduct a systematic study of copper in the bacteria Pseudomonas aeruginosa ...
(Date:11/24/2015)... 24, 2015 --> ... report "Oligonucleotide Synthesis Market by Product & Services (Primer, ... Diagnostic, DNA, RNAi), End-User (Research, Pharmaceutical & Biotech, Diagnostic ... the market is expected to reach USD 1,918.6 Million ... a CAGR of 10.1% during the forecast period. ...
(Date:11/24/2015)... , November 24, 2015 ... recent market research report released by Transparency Market Research, ... expand at a CAGR of 17.5% during the period ... Testing Market - Global Industry Analysis, Size, Volume, Share, ... global non-invasive prenatal testing market to reach a valuation ...
Breaking Biology Technology:
(Date:11/19/2015)...  Although some 350 companies are actively involved in ... companies, according to Kalorama Information. These include Roche Diagnostics, Hologic, ... share of the 6.1 billion-dollar molecular testing market, according ... Molecular Diagnostic s .    ... by one company and only a handful of companies ...
(Date:11/18/2015)... , November 18, 2015 ... published a new market report titled  Gesture Recognition Market ... Forecast, 2015 - 2021. According to the report, the global gesture ... is anticipated to reach US$29.1 bn by 2021, at ... North America dominated the global ...
(Date:11/17/2015)... Paris , qui s,est tenu ... Paris , qui s,est tenu du 17 au ... l,innovation biométrique, a inventé le premier scanner couplé, qui ... même surface de balayage. Jusqu,ici, deux scanners étaient nécessaires, ... digitales. Désormais, un seul scanner est en mesure de ...
Breaking Biology News(10 mins):