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:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality ... Several trends in analytical testing are being attributed to new regulatory requirements for ...
(Date:10/11/2017)... ... October 11, 2017 , ... ComplianceOnline’s Medical Device Summit is ... and 8th June 2018 in San Francisco, CA. The Summit brings together current and ... distinguished CEOs, board directors and government officials from around the world to address key ...
(Date:10/11/2017)... ... 2017 , ... A new study published in Fertility and ... in vitro fertilization (IVF) transfer cycles. The multi-center matched cohort study ... comparing the results from the fresh and frozen transfer cohorts, the authors of ...
(Date:10/10/2017)... ... October 10, 2017 , ... Dr. Bob Harman, founder and CEO of ... Rotary Club. The event entitled “Stem Cells and Their Regenerative Powers,” ... Dr. Harman, DVM, MPVM was joined by two human doctors: Peter B. Hanson, ...
Breaking Biology Technology:
(Date:8/23/2017)... -- The general public,s help is being enlisted in what,s thought to be ... on the human body –and are believed to affect health.  ... The Microbiome Immunity Project is the largest study ... gut. The project's goal is to help advance scientific knowledge of the ... ...
(Date:6/30/2017)... , June 30, 2017 Today, ... developer and supplier of face and eye tracking ... Featured Product provider program. "Artificial ... innovative way to monitor a driver,s attentiveness levels ... from being able to detect fatigue and prevent ...
(Date:5/23/2017)... , May 23, 2017  Hunova, the first robotic gym for ... has been officially launched in Genoa, Italy . The ... and the USA . The technology was ... the market by the IIT spin-off Movendo Technology thanks to a 10 ... Multimedia News Release, please click: ...
Breaking Biology News(10 mins):