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:9/30/2014)... 30, 2014 OriginOil Inc. (OTC/QB: OOIL), ... process to clean up large quantities of water, announced ... Eckelberry reported on the launch of the company's CLEAN-FRAC™ ... provided by partner STW Resources . , Immediately ... per day (bpd) and achieved a 99.8% reduction in ...
(Date:9/30/2014)... BALTIMORE and ROCKVILLE, Md., Sept. 30, 2014 /PRNewswire/ ... private-public partnership focusing on commercializing market-relevant biohealth innovations and ... Maryland , announced today that venture capitalist, ... as a strategic advisor. Dr. Fernandez will be a ... Gap Fund, which will provide up to $50 million ...
(Date:9/30/2014)... iLab Solutions announced the results of its ... focuses on core facility operations, growth and utilization as ... , In its 4th year running, a number of ... year-over-year decrease in the percentage of revenue that comes ... the constraints of this trend. When asked, “What are ...
(Date:9/30/2014)... The custom stainless steel fabrication company HOLLOWAY AMERICA ... Boston Area Chapter of ISPE (International Society for Pharmaceutical ... Wed., Oct. 1 at Gillette Stadium Clubhouse in Foxborough, ... ISPE Boston’s long history, with more than 375 exhibitors ... , HOLLOWAY AMERICA President David Simpson is looking forward ...
Breaking Biology Technology:OriginOil, Inc. Report to Shareholders: Blue Gold in West Texas 2Seasoned Life Sciences Venture Capitalist Tania Fernandez Joins BHI to Help Manage New BioHealth Gap Fund 2iLab Solutions Announces the Results of the 2014 Core Facility Benchmarking Study 2iLab Solutions Announces the Results of the 2014 Core Facility Benchmarking Study 3HOLLOWAY AMERICA to Exhibit at ISPE Boston Product Show 2014 2HOLLOWAY AMERICA to Exhibit at ISPE Boston Product Show 2014 3
... analysis results expected in Q3 2008 -, ... Therapeutics Inc.,(TSX:FXI) ("Fralex" or the "Company"), a ... today announced the,randomization of the 100th patient ... double-blind placebo-controlled randomized clinical trial,designed to assess ...
... Calif., March 10 AutoGenomics, a leader in,developing ... be among the leading healthcare and biotechnology companies ... that will be held at the,Boston Marriott Copley ... Executive Officer will present an overview of the,company, ...
... Nuclear Security Administration has awarded a $17 million cooperative ... Park to develop advanced simulations for commercial and defense ... center will focus on the behavior and reliability of ... of Excellence chosen by the NNSA. , About 35 ...
Cached Biology Technology:Fralex reaches 100th patient milestone in fibromyalgia study 2Fralex reaches 100th patient milestone in fibromyalgia study 3Purdue leads center to simulate behavior of micro-electromechanical systems 2Purdue leads center to simulate behavior of micro-electromechanical systems 3Purdue leads center to simulate behavior of micro-electromechanical systems 4
(Date:9/29/2014)... to a new Food and Brand Lab pilot study, ... participation in the National School Lunch Program (NSLP) by ... 16%! , Chefs Move to Schools (CMTS), an initiative ... schools in order to provide nutrition instruction to students ... , A CMTS event was held in an Upstate ...
(Date:9/29/2014)... team says recently identified radiation detection properties of a ... for homeland security and medical advances. , In a ... of Optics Letters , UT Arlington Physics Professor ... to fabricate transparent nanoscintillators by heating nanoparticles composed of ... formed. A scintillator refers to a material that ...
(Date:9/29/2014)... bad rap, and understandably so. The grain-of-rice-sized insects are ... of acres in the Western U.S. and Canada over ... belief, these pests may not be to blame for ... through the region. Instead, weather and topography play a ... these bark-boring beetles. , New research led by the ...
Breaking Biology News(10 mins):Chefs move to schools can increase school meal participation and vegetable intake among students 2UT Arlington researchers develop new transparent nanoscintillators for radiation detection 2UT Arlington researchers develop new transparent nanoscintillators for radiation detection 3Tree killers, yes, fire starters, no: Mountain pine beetles get a bad rap, study says 2Tree killers, yes, fire starters, no: Mountain pine beetles get a bad rap, study says 3Tree killers, yes, fire starters, no: Mountain pine beetles get a bad rap, study says 4
... both crop and ornamental plants. Each year, powdery mildew and ... intense research, little is known of the plant molecules that ... European research group lead by Ueli Grossniklaus, a plant geneticist ... Science shedding a new light on mildew susceptibility ...
... parent that takes their kid out for a walk knows ... that? Do kids and small adults walk differently from taller ... Peter Weyand from Southern Methodist University, USA, is fascinated by ... goes back to Max Kleiber,s work on resting metabolic rates ...
... are getting warmer. Conservative estimates suggest that tropical areas ... the end of this century. Does global warming spell ... at the Smithsonian Tropical Research Institute, and colleagues report ... million years ago rainforests prospered at temperatures that were ...
Cached Biology News:Fertility or powdery mildew resistance? 2Fertility or powdery mildew resistance? 3New equation calculates cost of walking for first time 2New equation calculates cost of walking for first time 3Tropical forest diversity increased during ancient global warming event 2
... is a dedicated fluorometer with ... kinds of assays in industrial ... clinical applications. Cell biology, immunology ... important application areas. Robot-friendly hardware ...
... design loaded with class-leading features, the 1400 Series will ... is safe and consistent every time you use it. ... Series reduces power consumption by as much as 50% ... the life of the cabinet. Multiply this savings ...
... The Magnetic Stand-96 is designed for ... microplates and 0.2 ml PCR plates with ... clear polyacryl base in a standard SBS ... extremely strong permanent magnets guarantees easy and ...
... designed to create the ideal environment for nucleic ... 99.9C) , Variable speed control (10 to ... it be for washing or hybridizing , ... inside the chamber, ,is situated above a touch ...
Biology Products: