Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Luminex Receives FDA and European Clearance for New Version of xTAG® CYP2D6 Kit

Published: Tuesday, July 16, 2013
Last Updated: Tuesday, July 16, 2013
Bookmark and Share
Luminex submits xTAG® CYP2C19 kit to FDA for review.

Luminex Corporation has announced that it has received U.S. FDA and European clearance for a new version of xTAG CYP2D6 Kit.

Additionally the company has submitted xTAG 2C19 Kit to FDA for review. Luminex is advancing its pharmacogenetic initiative for improved patient care.

"Test results that inform a physician on how a patient may react to a particular therapeutic are vital to improving patient care," said Patrick J. Balthrop, president and chief executive officer of Luminex.

Balthrop continued, "Pharmacogenetics is a fast-growing field and our flexible technology provides laboratories unique options to address their needs. Attaining FDA and CE clearance for xTAG CYP2D6 Kit demonstrates Luminex's commitment to offering diagnostics that optimize patient outcomes and lower overall health-care costs."

Cytochrome P450 2D6 (CYP2D6) is a clinically important gene that encodes a phase one drug metabolizing enzyme. CYP2D6 metabolizes greater than 25% of the drugs in use today including cardiovascular drugs, anti-psychotics, anti-depressants, pain-medications, β-blockers, anti-emetics, antiarrhythmics and anti-cancer drugs.

Variations in the CYP2D6 gene can result in distinct drug metabolizing phenotypes leading to sub-optimal drug responses, such as drug toxicity, adverse drug reactions (ADRs), or inadequate therapeutic effect.

An estimated 2.2 million serious ADRs occur yearly resulting in 100,000 deaths at a cost of $136 billion in the United States alone.

xTAG CYP2D6 Kit is an IVD assay that analyzes a patient's CYP2D6 genotype from DNA extracted from a blood sample to aid physicians in determining therapeutic strategy for drugs metabolized by the cytochrome P450 2D6 gene product.

The assay is run on the flexible Luminex® 100/200™ instrument. This new version of the kit optimizes performance on the *17 allele and features an updated software algorithm that detects all 17 genotypes that the assay is cleared for, including deletion and duplication genotypes.

Luminex has also submitted xTAG CYP2C19 Kit for FDA and CE-clearance. The CYP2C19 enzyme is responsible for metabolizing a variety of prodrugs and drugs used to treat ulcers, seizures, malaria and anxiety. It is also partially responsible for metabolizing drugs such as beta-blockers and some antidepressants.

Luminex will be featuring the new xTAG CYP2D6 Kit at the American Association of Clinical Chemistry (AACC) Annual Meeting & Clinical Lab, July 30 - Aug. 1 in Houston, TX, Booth #4539. Visit the Luminex booth for more information on Luminex's pharmacogenetic portfolio.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Luminex to Acquire Nanosphere
Nanosphere to be acquired for $1.35 per share in an all cash transaction valued at approximately $58 million.
Monday, May 16, 2016
Luminex SYNCT Software Receives FDA Clearance, CE Mark
Company has announced that its SYNCT™ Software has received both U.S. FDA clearance and CE Marking for use with its ARIES® System and NxTAG® assays on the MAGPIX® System.
Friday, April 15, 2016
Luminex Receives CE-IVD Mark for ARIES System
The ARIES® System and ARIES®HSV 1&2 Assay previously received FDA clearance in October 2015 and were subsequently launched in the U.S. market.
Tuesday, March 22, 2016
Luminex, University of Sao Paulo Collaborate
Luminex Corporation has announced it is collaborating with the Laboratory of Molecular Evolution & Bioinformatics, Biomedical Sciences Institute, University of São Paulo, Brazil to validate a multi-analyte Zika virus assay developed by Luminex partner,GenArraytion, Inc.
Monday, February 29, 2016
Luminex Corporation Announces Collaboration with University of Sao Paulo
Company has announced collaboration to validate a multi analyte zika virus detection panel for detect multiple disease agent.
Friday, February 26, 2016
Luminex Corporation Receives Medical Device License
Company has announced that it has received medical device licenses from Health Canada's Therapeutic Products Directorate for ARIES System and ARIES HSV 1&2 Assay.
Tuesday, February 23, 2016
Luminex and Bio-Techne Extend and Expand Partnership
Company expands global distribution of award-winning multiplexing instrumentation.
Friday, October 23, 2015
Luminex Receives FDA Clearance
Company has received clearance for ARIES® System and ARIES® HSV 1&2 Assay.
Thursday, October 08, 2015
Luminex Receives FDA and European Clearance for xTAG® CYP2C19 Kit
New cytochrome P450 2C19 assay helps physicians optimize individual patient care.
Tuesday, September 24, 2013
Luminex Corporation Reports Second Quarter 2013 Results
Achieves milestone selling 10,000th multiplexing analyzer.
Tuesday, July 30, 2013
Merck and Luminex Corporation Enter Agreement
Collaboration to support patient selection for the clinical development of MK-8931, Merck’s lead investigational medicine for Alzheimer’s disease.
Thursday, July 04, 2013
Luminex Corporation Reports First Quarter 2013 Results
Gained FDA clearance for novel Gastrointestinal Pathogen Panel.
Thursday, May 02, 2013
Luminex Receives FDA Clearance for xTAG Gastrointestinal Pathogen Panel
xTAG® GPP simultaneously tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single molecular test.
Tuesday, April 23, 2013
Luminex Corporation Receives U.S. FDA Clearance for MAGPIX® Instrument
Innovative multiplexing instrument for clinical laboratories with simultaneous testing for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single molecular test.
Monday, April 15, 2013
Luminex Corporation Awarded $11 Million Contract by Defense Threat Reduction Agency (DTRA)
Department of Defense award accelerates development of Luminex bio-threat detection technology program.
Thursday, August 16, 2012
Scientific News
Loss Of Y Chromosome Increases Risk Of Alzheimer’s
Men with blood cells that do not carry the Y chromosome are at greater risk of being diagnosed with Alzheimer’s disease. This is in addition to an increased risk of death from other causes, including many cancers. These new findings by researchers at Uppsala University could lead to a simple test to identify those at risk of developing Alzheimer’s disease.
Making Virus Sensors Cheap and Simple
Researchers at The University of Texas at Austin demonstrated the ability to detect single viruses in a solution containing murine cytomegalovirus (MCMV).
Heart Defect Prediction Technology Could Lead to Earlier, More Informed Treatment
Experimental method uses genetics-guided biomechanics, patient-specific stem cells.
Biosensor Detects Molecules Linked to Cancer, Alzheimer's and Parkinson's
Novel biosensor has been proven capable of detecting molecules associated with neurodegenerative diseases and some types of cancer.
Big Data Can Save Lives
The sharing of genetic information from millions of cancer patients around the world could be key to revolutionising cancer prevention and care, according to a leading cancer expert from Queen's University Belfast.
Fast, Simple Test for Colitis
A minimally invasive screening for ulcerative colitis using emerging infrared technology could be a rapid and cost-effective method for detecting disease that eliminates the need for biopsies and intrusive testing of the human body.
Scans Reveal Babies of Mothers with Gestational Diabetes Have More Body Fat
Researchers at Imperial College London have found that the babies born to mothers with gestational diabetes have more body fat at two months of age compared to babies born to healthy mothers.
New Device Could Improve Cancer Detection
UBC researchers develop a microfluidic device to capture circulating tumor cells.
Plasma Biomarkers for Breast Cancer Diagnosis
Plasma lipidomics profiling identified lipid biomarkers in distinguishing early-stage breast cancer from benign lesions.
Newborn Screening Test Developed For Rare, Deadly Neurological Disorder
Scientists have developed a new dried blood spot screening test for Niemann-Pick type C, with goal to speed diagnosis and treatment.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!