Corporate Banner
Satellite Banner
Genotyping & Gene Expression
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Luminex Receives FDA and European Clearance for xTAG® CYP2C19 Kit

Published: Tuesday, September 24, 2013
Last Updated: Tuesday, September 24, 2013
Bookmark and Share
New cytochrome P450 2C19 assay helps physicians optimize individual patient care.

Luminex Corporation has announced that it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit.

This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

"Since cytochrome [CYP450] enzymes are responsible for metabolizing over half of all drugs on the market today, it is important for a physician to have valuable information to determine whether a patient's specific genotype may impact their drug response," said Patrick J. Balthrop, president and chief executive officer of Luminex.

Balthrop continued, "Our growing portfolio of pharmacogenetic assays include both FDA cleared and CE marked xTAG CYP2D6 and CYP2C19 assays demonstrating our commitment to offer testing laboratories regulatory cleared assays that are safe and effective for use as an aid in patient management decisions."

Cytochrome P450 2C19 (CYP2C19) is a clinically important gene that encodes a phase one drug metabolizing enzyme.

The CYP2C19 enzyme is responsible for metabolizing a variety of prodrugs and drugs used to treat a number of conditions such as ulcers, seizures, malaria and anxiety. It is also important in metabolizing drugs such as beta-blockers, anti-clotting agents and some antidepressants.

Genetic variations in the CYP2C19 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.

The FDA Adverse Events Reporting system (FAERS) estimated nearly 800,000 ADRs in the U.S. and Europe combined for the year 2011.

The incidence of serious and fatal ADRs has been rising with the increase in the number of medications prescribed.

An estimated $3.5 billion is spent on additional medical cost associated with ADRs annually and at least 40% of ambulatory ADRs may be preventable.

Luminex's xTAG CYP2C19 Kit is an IVD assay that analyzes a patient's CYP2C19 genotype from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples to aid clinicians in determining therapeutic strategy for therapeutics metabolized by the cytochrome P450 2C19 gene product.

The assay is run on the versatile Luminex® 100/200™ or MAGPIX® instruments.


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 2,900+ scientific posters on ePosters
  • More than 4,200+ 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 Technology Selected by Assurex Health
xTAG® Technology to aid in GeneSight® precision medicine test.
Saturday, March 21, 2015
Pioneering Human Protein Atlas Project Achieves a Major Milestone
Project leverages Luminex's xMAP® technology for biobank profiling research.
Thursday, March 20, 2014
Luminex Receives FDA and European Clearance for New Version of xTAG® CYP2D6 Kit
Luminex submits xTAG® CYP2C19 kit to FDA for review.
Tuesday, July 16, 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 and EMD Millipore Extend Their Global Supply and Distribution Agreement
This long-term agreement strengthens the partnership and facilitates development of life science and protein assays.
Thursday, May 30, 2013
Luminex Awarded $11 Million Contract by DTRA
Department of defense award accelerates development of Luminex bio-threat detection technology program.
Tuesday, August 14, 2012
Luminex Corporation Expands Life Science and Biodefense Groups
Two dedicated groups advance Luminex leadership in scientific research and public safety.
Thursday, April 26, 2012
Luminex and Partners HealthCare Announce Collaboration Agreement
Collaborative efforts aimed at translating biomarker discoveries into novel molecular diagnostic tests.
Wednesday, February 16, 2011
Luminex Corporation Launches New FDA Cleared Pharmacogenetic Diagnostic Test
xTAG® CYP2D6 kit can assist physicians in improving patient care by helping to determine a personalized therapeutic strategy.
Thursday, November 18, 2010
Luminex Corporation and ViroNovative Announce License Agreement for Human Metapneumovirus Rights
Luminex gains worldwide rights to use ViroNovative's human metapneumovirus intellectual property in the xTAG Respiratory Viral Panel.
Tuesday, July 15, 2008
Luminex Receives U.S. Food and Drug Administration Clearance for xTAG™ Respiratory Viral Panel
The Company has designed the test to simultaneously detect the most prevalent respiratory viruses.
Friday, January 04, 2008
Luminex Licenses Cystic Fibrosis Gene Patent from John Hopkins University
Luminex’s TAG-IT™ cystic fibrosis kits to include rights to university's proprietary genetic markers.
Tuesday, April 24, 2007
Luminex Hosts Planet xMAP Technology Symposium
The symposium includes presentations and workshops utilizing Luminex's xMAP® technology in clinical diagnostics and life sciences research.
Tuesday, April 25, 2006
Scientific News
Common Cell Transformed into Master Heart Cell
By genetically reprogramming the most common type of cell in mammalian connective tissue, researchers at the University of Wisconsin—Madison have generated master heart cells — primitive progenitors that form the developing heart.
Genetic Mutation that Prevents Diabetes Complications
The most significant complications of diabetes include diabetic retinal disease, or retinopathy, and diabetic kidney disease, or nephropathy. Both involve damaged capillaries.
Charting Kidney Cancer Metabolism
Changes in cell metabolism are increasingly recognized as an important way tumors develop and progress, yet these changes are hard to measure and interpret. A new tool designed by MSK scientists allows users to identify metabolic changes in kidney cancer tumors that may one day be targets for therapy.
Individuals' Medical Histories Predicted by their Noncoding Genomes
Researchers have found that analyzing mutations in regions of the genome that control genes can predict medical conditions such as hypertension, narcolepsy and heart problems.
'Molecular Movie' Opens Door to New Cancer Treatments
An international team of scientists led by the University of Liverpool has produced a 'structural movie' revealing the step-by-step creation of an important naturally occurring chemical in the body that plays a role in some cancers.
Custom Tuning Knobs to Turn Off Any Gene
Factory managers can improve productivity by telling workers to speed up, slow down or stop doing tangential tasks while assembling widgets. Unfortunately for synthetic biologists attempting to produce pharmaceuticals, microbes don’t respond to direction like human personnel.
Unique Mechanism for a High-Risk Leukemia
Researchers uncovered the aberrant mechanism underlying a notoriously treatment-resistant acute lymphoblastic leukemia subtype; findings offer lessons for understanding all cancers.
Genetically Mapping the Most Lethal E.Coli Strains
New approach could lead to fewer deaths, and new treatments.
The Spice of Life
Scientists discover important genetic source of human diversity.
Cytoskeleton Crew
Findings confirm sugar's role in helping cancers survive by changing cellular architecture.
SELECTBIO

Skyscraper Banner
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!