Navigation Links
Spartan Bioscience Receives FDA Clearance for First Rapid DNA Test of Mutations Affecting Metabolism of Common Drugs
Date:8/27/2013

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: 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.

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 http://www.prweb.com/releases/2013/8/prweb11049756.htm.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... , March 27, 2017 DarioHealth Corp. ... mobile health and big data solutions, today announced that ... insurance coverage option for U.S. consumers who want to ... DarioHealth has signed strategic alliance agreements with partners ... insurance coverage benefits, and if approved, will supply and ...
(Date:3/24/2017)... BEIJING , March 24, 2017 Sinovac Biotech Ltd. ... products in China , today announced that its ... the expiration date of the plan from March 27, 2017 to ... proposal. About Sinovac Biotech Ltd. ... Sinovac Biotech Ltd. is ...
(Date:3/23/2017)... ... ... proud to announce it has become the premiere team-building cooking event company in San Diego. ... such as Illumina, HP and Qualcomm, and is ranked #1 in its category on Trip ... its new team building format, a way for teams to not only interact with one ...
(Date:3/23/2017)...  BioPharmX Corporation (NYSE MKT: BPMX), a specialty ... today reported financial results for the quarter and ... an update on the company,s clinical development efforts ... are pleased to report that last year was ... Anja Krammer. "We achieved key clinical milestones and ...
Breaking Biology Technology:
(Date:3/27/2017)... March 27, 2017  Catholic Health Services (CHS) ... Systems Society (HIMSS) Analytics for achieving Stage 6 ... sm . In addition, CHS previously earned a ... using an electronic medical record (EMR). ... level of EMR usage in an outpatient setting.  ...
(Date:3/24/2017)... The Controller General of Immigration from Maldives Mr. ... have received the prestigious international IAIR Award for the most innovative ... ... Maldives Immigration ... Algeen (small picture on the right) have received the IAIR award for ...
(Date:3/24/2017)... , Mar 24, 2017 Research and ... Access System Market Analysis & Trends - Industry Forecast to 2025" ... ... to grow at a CAGR of around 15.1% over the next ... This industry report analyzes the market estimates and forecasts for all ...
Breaking Biology News(10 mins):