Navigation Links
First Point-of-Care DNA Test Submitted for FDA Clearance by Spartan Bioscience
Date:1/10/2013

Ottawa, Ontario (PRWEB) January 10, 2013

Spartan Bioscience, the leading point-of-care DNA testing company, today announced that it has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its Spartan RX CYP2C19 genetic test.

CYP2C19 is an enzyme that metabolizes commonly-prescribed drugs, including antiarrhythmics, proton pump inhibitors, antidepressants, and antiplatelet drugs. About 30% of Caucasians, 40% of Africans, and more than 50% of Asians and Indians carry CYP2C19 gene variants that reduce response to drugs metabolized by CYP2C19.(1,2,3,4)

“This is an important milestone in Spartan’s growth strategy,” said Paul Lem, M.D., CEO of Spartan Bioscience. “The United States is the world's largest market for genetic testing.”

About the Spartan RX CYP2C19
The Spartan RX CYP2C19 is the first point-of-care DNA test in medicine.(5) It identifies carriers of certain CYP2C19 genetic mutations in 1 hour. These mutations are carried by approximately 30 percent of the world’s population. Currently, genetic testing is performed in central labs and it takes up to seven days to get a test result back. The Spartan RX CYP2C19 has CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark. Spartan Bioscience is working towards FDA 510(k) clearance in the United States. For more information, please visit our website at: http://www.spartanbio.com/products/spartan-rx

About Spartan Bioscience
Spartan Bioscience is the leader in point-of-care DNA testing. The Spartan RX is the first complete sample-to-result, point-of-care DNA testing system in medicine. It is a fully integrated DNA collection, extraction and analysis platform, with an intuitive interface that is easy to operate—no laboratory training required. 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.

1. Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–11.
2. Chen M et al. (2011). Atherosclerosis. 220(1):168–71.
3. Oh IY et al. (2012). Heart. 98(2):139–44.
4. Jose R et al. (2004). Fundamental & Clinical Pharmacology. 19(1): 101–105.
5. Roberts JD et al. (2012). Lancet. 379: 1705–1711.

Read the full story at http://www.prweb.com/releases/2013/1/prweb10303744.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Bottom-up approach provides first characterization of pyroelectric nanomaterials
2. First Bedside DNA Test to be Distributed by Chirus in UK
3. First Maryland Hospital Offering 3D Mammograms? VA Maryland Health Care System
4. BioTechniques Announces the Publication of 'Transfection' – The First Issue of a New, Digital-Only Spotlight Series
5. Dallas-Fort Worth Fertility Associates Celebrates First Birth in North Texas from Advanced Trophectoderm Biopsy Screening Technology
6. First Warning Systems and Unicorp Biotech International Strategic Partner Letter of Intent Signed Breast Cancer Early Detection
7. First Suit Against Nobel Prize Organization Citing Defamation And Unfair Competition Practices Is Filed
8. Topokine Announces Dosing of First Subject in a Phase I Clinical Trial of XAF5 Gel for Local Reduction of Subcutaneous Fat
9. Karmanos Cancer Center first in Midwest to offer latest Molecular Breast Imaging
10. China Cord Blood Corporation Reports Financial Results for the Second Quarter and First Half of Fiscal 2013
11. First Effective Treatment For Traumatic Brain Injury Reported by Institute of Neurological Recovery, Even Years After Injury
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... ... May 03, 2016 , ... In a list published ... of the state’s 76 fastest-growing private companies; a small percentage of the state's 615,000+ ... organizations on the percent change in revenue from 2012 to 2015. , ...
(Date:5/3/2016)... ... May 03, 2016 , ... Kerafast Inc., ... materials from laboratories across the globe, today announced the availability of a Zika ... of research toward treatment and prevention measures for the Zika virus, the virus’s ...
(Date:5/3/2016)...  Dr. Thomas P. McHugh , an internationally ... Woodlands, Texas , now offers SculpSure, the new ... cells in just 25-minutes, leaving a slimmer figure for ... Americans report feeling bothered by excess weight and are ... a growing industry. This innovative new approach to non-invasive ...
(Date:5/2/2016)... YORK , May 2, 2016 ... announces that its technology partner Mannin Research Inc. will ... Ophthalmology (ARVO), which takes place from May 1-5, 2016 ... executives will be meeting with its vendors and research ... explore business development goals and other collaborative opportunities for ...
Breaking Biology Technology:
(Date:3/23/2016)... WAKEFIELD, Massachusetts , March 23, 2016 ... kombiniert im Interesse erhöhter Sicherheit Gesichts- und ... Xura, Inc. (NASDAQ: MESG ... heute bekannt, dass das Unternehmen mit SpeechPro ... insbesondere aus der Finanzdienstleistungsbranche, wird die Möglichkeit ...
(Date:3/21/2016)... 22, 2016 Unique technology ... for superior security   Xura, ... of secure digital communications services, today announced it is ... offer enterprise customers, particularly those in the Financial Services ... voice authentication within a mobile app, alongside, and in ...
(Date:3/15/2016)... York , March 15, 2016 ... market report published by Transparency Market Research "Digital Door Lock ... and Forecast 2015 - 2023," the global digital door lock ... 731.9 Mn in 2014 and is forecast to grow at ... Growth of micro, small and medium enterprises (MSMEs) across the ...
Breaking Biology News(10 mins):