Navigation Links
First Point-of-Care DNA Test Submitted for FDA Clearance by Spartan Bioscience

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:

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:

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

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:
(Date:10/8/2015)... Oct. 8, 2015 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: ... focused on the development of autologous cell therapies, today announced ... meetings taking place in the month of October: ... Forum RepliCel will be presenting at the annual ... the Mesa to be held October 7-9 in ...
(Date:10/8/2015)... TORONTO, CANADA (PRWEB) , ... October 08, 2015 ... ... it has entered into an exclusive license agreement to develop and commercialize intellectual ... expands upon the original agreement from February 2009, and affords exclusive worldwide rights ...
(Date:10/7/2015)... ... 07, 2015 , ... Neil Riordan, PhD to Discuss Medicinal Effects of Mesenchymal ... Mar-a-Lago from 3:50 pm to 4:30 pm. , Dr. Riordan is one of the ... He is the Co-Founder and Chief Science Officer of the Riordan-McKenna Institute ...
(Date:10/7/2015)...   PDI , a leader in infection prevention ... key challenges across various healthcare settings, as well as ... This tool is part of a larger effort to ... efficiencies and lower healthcare-associated infections. ... of how to use the right product, in the ...
Breaking Biology Technology:
... JOLLA, Calif., Oct. 20, 2011 Regulus Therapeutics ... development of innovative medicines targeting microRNAs, and collaborators at ... Center today announced the publication of new pre-clinical research ... et al., Nature , October 20, 2011). ...
... cell carcinomas are amongst the most frequent cancers in ... like many other human cancers, contain particular cancer cells, ... potential that sustain tumor growth. Little is known about ... High level of VEGF expression in skin cancer ...
... Researchers at Purdue University and the National Institute of ... enough to fit on a computer chip that converts ... that might have applications in more advanced sensors, communications ... very high rates, corresponding to hundreds of billions of ...
Cached Biology Technology:
(Date:10/9/2015)... 09 2015 ... the "Samsung Galaxy S6 Fingerprint Sensor ... their offering. --> ) ... "Samsung Galaxy S6 Fingerprint Sensor - Reverse ... --> Research and Markets ( ...
(Date:10/8/2015)... Oct. 8, 2015 Synaptics Inc. (NASDAQ: ... solutions, announced today that it will report financial ... on Thursday, October 22, 2015, after the close ... conference call for analysts and investors at 2:00 ... may discuss forward-looking information. ...
(Date:10/8/2015)... SALT LAKE CITY , 8. Oktober ... (OTCQX: TRCK), ein global tätiges Unternehmen des ... man einem Vertrag mit der Gefängnisbehörde Virginias ... in dessen Rahmen elektronische Überwachungsdienste für alle ... Derek Cassell , Präsident für ...
Breaking Biology News(10 mins):
... popular with consumers who like the convenience and ... table grapes fresh and increase shelf life, scientists ... alternatives to conventional packing methods. Researchers from the ... ARS) have developed and tested an effective new ...
... OHLoblolly pine bark is the primary component of nursery ... shortage of the widely used organic material is prompting ... recent study by James E. Altland and Charles Krause ... Agricultural Research and Development Center was designed to determine ...
... within patient records or detailed in newspaper clippings can ... the discovery of trends that were previously overlooked, according ... interactive maps and graphs, combined with word search interfaces, ... the spread of Swine flu," said Frank Hardisty, research ...
Cached Biology News:
Human IL-19 MAb (Clone 152112)...
geminin, DNA replication inhibitor...
Cytidine 5'-Triphosphate, Sodium (CTP), 1 g. Category: Nucleotides & Enzymes & Biochemicals, Nucleotides, Additional Nucleotide Products....
Human IL-17D Affinity Purified Polyclonal Ab...
Biology Products: