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 mainf
'/>"/>

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

Page: 1 2

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:1/15/2014)... (PRWEB) January 15, 2014 DTS Language ... its Online Web Portal for Life Science organizations who need ... specify the subject matter of their documents in advance with ... help reduce time-to-delivery of translations, often a critical factor in ...
(Date:1/15/2014)... TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they ... Russian pharmaceutical company, to develop and commercialize nemonoxacin (Taigexyn ... , Turkey and other members ... antibiotic for the treatment of bacterial infections including those ...
(Date:1/14/2014)... Communications, a leading provider of strategic communications services to corporations and ... the United States and Europe ... JD, is returning to the firm,s Washington, D.C. ... more than two years of service as Associate Commissioner for the ...
(Date:1/14/2014)... BETHESDA, Md. , Jan. 14, 2014  Organovo ... institutes from the National Institutes of Health (NIH) to ... more effective treatments to patients on a faster timeline. ... Translational Sciences (NCATS) and the National Eye Institute (NEI) ...
Breaking Biology Technology:DTS Improves Efficiency for Life Science Document Translations 2TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 2TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 3TaiGen Biotechnology Signed Exclusive License Agreement with R-Pharm for Nemonoxacin (Taigexyn(R)) 4Former FDA Associate Commissioner Returns To 3D Communications 2Organovo Announces Collaboration with National Institutes of Health 2Organovo Announces Collaboration with National Institutes of Health 3
... Jan. 26, 2012 Amgen (NASDAQ: AMGN ... today announced that the companies have entered into a ... a biotechnology company founded in Germany with its research ... Rockville, Md., for $11 per share in cash. The ...
... 2012 Sequenom, Inc. (NASDAQ: SQNM ) today ... shares of its common stock, including 1,950,000 shares sold pursuant ... to the underwriters. All of the shares were offered by ... share. The gross proceeds to Sequenom from this offering were ...
... Novartis Pharmaceuticals Corporation (NPC) and Sanford Wittels & Heisler, LLP, ... agreement to resolve the nationwide Wage and Hour class action ... the Southern District of New York.  NPC ... payment of up to 99 million dollars for eligible class ...
Cached Biology Technology:Amgen to Acquire Micromet 2Amgen to Acquire Micromet 3Amgen to Acquire Micromet 4Amgen to Acquire Micromet 5Amgen to Acquire Micromet 6Amgen to Acquire Micromet 7Amgen to Acquire Micromet 8Amgen to Acquire Micromet 9Sequenom Announces Exercise in Full of Over-Allotment Option and Completion of Public Offering of Common Stock 2Sequenom Announces Exercise in Full of Over-Allotment Option and Completion of Public Offering of Common Stock 3Plaintiff Sales Representatives and Novartis Pharmaceuticals Corporation Resolve Class Action Wage and Hour Claims 2Plaintiff Sales Representatives and Novartis Pharmaceuticals Corporation Resolve Class Action Wage and Hour Claims 3Plaintiff Sales Representatives and Novartis Pharmaceuticals Corporation Resolve Class Action Wage and Hour Claims 4
(Date:4/17/2014)... one per eight hundred births, Down syndrome - or ... of intellectual disability. It results from a chromosomal abnormality ... of chromosome 21 (1% of the human genome). A ... the Department of Genetic Medicine and Development at the ... Nature , shed light on how the extra ...
(Date:4/17/2014)... years ago, Katia Silvera , a postdoctoral scholar at ... a field trip in a mountainous area in central Panama ... before. , Unable to identify it, they contacted German Carnevali, ... to be an unnamed species. So Carnevali recently named it ... the genus name, comprising about 40 species in the world. ...
(Date:4/17/2014)... deforestation and fragmentation of forests in the Amazon ... forests, contributing to rapid and widespread forest loss ... researchers., The findings show that forests in the ... droughts coupled with forest fires lead to large-scale ... Jennifer Balch, assistant professor of geography, Penn State. ...
Breaking Biology News(10 mins):Trisomy 21: How an extra little chromosome throws the entire genome off balance 2Trisomy 21: How an extra little chromosome throws the entire genome off balance 3Orchid named after UC Riverside researcher 2Orchid named after UC Riverside researcher 3Drought and fire in the Amazon lead to sharp increases in forest tree mortality 2Drought and fire in the Amazon lead to sharp increases in forest tree mortality 3
... University of Illinois have developed a new, more accurate ... that results from changes in land use. The ... Biology , takes into account many factors not included ... is an urgent need to accurately assess whether particular ...
... delivering oxygen to our vital organs are obstructed by atherosclerosis ... attack or damage to a peripheral tissue such as the ... injury or destruction from a choked-off blood supply varies from ... whose circulatory system has the best back-up plan to provide ...
... A Montreal study finds heterotrophic bacteria counts, in ... the recommended limits specified by the United States Pharmacopeia ... today at the 110th General Meeting of the American ... the cleanest tap water a large number of urban ...
Cached Biology News:Researchers calculate the greenhouse gas value of ecosystems 2Researchers calculate the greenhouse gas value of ecosystems 3Study pinpoints new role of molecule in the health of body's back-up blood circulation 2Study pinpoints new role of molecule in the health of body's back-up blood circulation 3Study pinpoints new role of molecule in the health of body's back-up blood circulation 4Study finds high level of bacteria in bottled water in Canada 2
... allows the Thermo-Fast® 96 ... PCR plates to be ... PRISM® 3700 capillary sequencer. ... information on the software ...
... • Heat activated ,• ... room temperature ,• Excellent specificity allows ... and secondary structures ,• Leaves an ... chemically modified form of GeneChoice DNA Polymerase ...
... aqueous solution. Cleaves a-(1-3)- ... carbohydrates and glycoproteins. It is particularly efficient ... the pH must be neutral or above, ... Unit Definition: One unit will ...
This adapter allows the Thermo-Fast® 96 Semi-Skirted (AB-0900 and AB-0990) PCR plates to be used directly in the ABI PRISM® 3100 sequencer without the need for software changes....
Biology Products: