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 require
'/>"/>

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

Page: 1 2

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:8/28/2014)... “This kit has an improved extraction efficiency and provides ... ppb,” said Mark Tess, PhD, Mycotoxin Product Manager for Charm ... and USDA-GIPSA inspection agencies that have a need to detect ... in a matter of minutes with nothing but our equipment ... and grain before accepting it, but they no longer have ...
(Date:8/28/2014)... The ability for organizations to attract top ... individuals to perform at the highest of levels, are ... to compete in this post–recession era. The pharmaceutical ... the sector increasingly focuses on the importance of employee-fit ... real results on the organization's development and the innovation ...
(Date:8/28/2014)... MENLO PARK, Calif. , Aug. 28, 2014 ... company focused on developing novel mid- to late-stage ... raised $7.0 million in its first round of ... AshHill Biomedical Investments and Hercules Bioventures with participation ... biotech entrepreneur and pharmaceutical executive, Dr. Larry ...
(Date:8/28/2014)... 2014 Earlier this month, a ... partnership with the U.S. Air Force on the performance ... indicated that this type of fuel made from mustard ... be important to America’s Eco friendly future. In fact, ... mandate to become independent of foreign oil over the ...
Breaking Biology Technology:Klein Hersh International Leads Philadelphia Area Life Science Industry in Company Culture 2Klein Hersh International Leads Philadelphia Area Life Science Industry in Company Culture 3Armetheon Completes $7.0 Million Series A Financing 2Armetheon Completes $7.0 Million Series A Financing 3Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 2Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 3Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 4Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 5
... 24, 2011 Amgen (Nasdaq: AMGN ) today ... full year financial results on Monday, Jan. 24, 2011 after ... followed by a conference call with the investment community at ... will be Kevin Sharer, chairman and chief executive officer, and ...
... (Nasdaq: CEPH ) will hold a public memorial service ... and CEO on February 1, 2011, at 6:00 p.m. at The ... Dr. Baldino founded Cephalon in 1987 and led the ... ten biotechnology companies in the world. He was a recognized pioneer ...
... a strategy-driven biotech and pharmaceutical product development company, announced ... the National Institutes of Health (NIH) Therapeutics for Rare ... and development partner. The RRD and ... development projects: Hereditary Inclusion Body Myopathy (HIBM), a rare ...
Cached Biology Technology:Amgen Announces Webcast of 2010 Fourth Quarter and Full Year Financial Results 2Cephalon to Hold Public Memorial Service to Celebrate the Life of Company Founder, Frank Baldino, Jr., Ph.D. 2RRD Selected as Development Partner for NIH Therapeutics for Rare and Neglected Diseases Program 2RRD Selected as Development Partner for NIH Therapeutics for Rare and Neglected Diseases Program 3
(Date:8/29/2014)... been known about what genetic changes transform wild animals ... of whom is a University of Montana assistant professor, ... the development of the brain and the nervous system ... published Aug. 28 in Science and gives ... http://www.sciencemag.org/ ., The domestication of animals and plants, ...
(Date:8/29/2014)... This news release is available in German . ... of chemical signals between organisms is considered the oldest ... social interactions between conspecifics, for example, the sexual attraction ... trigger social responses and to coordinate reproductive behavior in ... at the University of the Algarve in Faro, Portugal, ...
(Date:8/28/2014)... app called TX Invasives is now available from the ... Texas at Austin for identifying harmful non-native plant, insect ... in the United States cause about $137 billion in ... crops, clog waterways, kill native plants and more. , ... for reporting where invasive species occur, we,re more likely ...
Breaking Biology News(10 mins):New research reveals how wild rabbits were genetically transformed into tame rabbits 2New research reveals how wild rabbits were genetically transformed into tame rabbits 3Ready for mating at the right time 2Ready for mating at the right time 3Mobile app makes ID of harmful plants, insects in Texas a snap 2
... below are the selected highlights for the July 2012 issue ... The July issue is available online at www.genetics.org/content/current ... 2012, Copyright 2012. ISSUE HIGHLIGHTS , ... studies through the use of meta-analysis for structured populations , ...
... Researchers at the Translational Genomics Research Institute (TGen) have developed ... less costly, less invasive and more accurate way of diagnosing ... complication of diabetes, high blood pressure and a form of ... progressive deterioration of the kidney,s ability to filter waste from ...
... satellite imagery have been limited by weather. Clouds, in ... However, University of Iowa scientists have created a ... better estimate the concentration of pollutants, such as soot. ... block remote-sensing satellites, ability to detect, and thus calculate, ...
Cached Biology News:Genetics Society of America's Genetics journal highlights for July 2012 2Genetics Society of America's Genetics journal highlights for July 2012 3TGen method isolates biospecimens for treatment of kidney disease 2UI researchers develop technique to help pollution forecasters see past clouds 2
... Mouse anti-Yersinia pestis F1 antigen, Monoclonal ... ELISA: Use at an ... an assay dependent dilution. WB: Use ... molecular weight: 18 kDa. Not tested ...
Anti-Phospho-JKK/SEK1/MKK4 pAb Description: 100 g rabbit polyclonal antibody. Reacts with human/mouse/rat. Tested in WB. Research Focus: signal transduction Storage: -20C Shipping Tem...
... A - Fixation medium Reagent B - ... for fixing cells in suspension with Reagent ... Reagent B. This procedure gives antibodies access ... scatter characteristics of the cells intact. Specific ...
... formulated for covering tissue sections and cell preparations immunohistochemically stained ... , ... Application: Vision Mount ... that require an aqueous mounting medium, or those that do ...
Biology Products: