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
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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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
The Genetic Roots of Adolescent Scoliosis
Scientists at the RIKEN Center for Integrative Medical Sciences in collaboration with Keio University in Japan have discovered a gene that is linked to susceptibility of Scoliosis.
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
How a Kernel Got Naked and Corn Became King
Ten thousand years ago, a golden grain got naked, brought people together and grew to become one of the top agricultural commodities on the planet.
New Tool For Investigating RNA Gone Awry
A new technology – called “Sticky-flares” – developed by nanomedicine experts at Northwestern University offers the first real-time method to track and observe the dynamics of RNA distribution as it is transported inside living cells.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
Oxitec ‘Self-Limiting Gene’ Offers Hope for Controlling Invasive Moth
A new pesticide-free and environmentally-friendly way to control insect pests has moved ahead with the publication of results showing that Oxitec diamondback moths (DBM) with a ‘self-limiting gene’ can dramatically reduce populations of DBM.
Teeth Reveal Lifetime Exposures to Metals, Toxins
Researchers have identified dental biomarkers to reveal links between early iron exposure and late life brain diseases.
Scientists Identify Schizophrenia’s “Rosetta Stone” Gene
Scientists have identified a critical function of what they believe to be schizophrenia’s “Rosetta Stone” gene that could hold the key to decoding the function of all genes involved in the disease.
Could a simple saliva test detect Alzheimer's?
Researchers have presented findings suggesting that a simple, non-invasive diagnostic for Alzheimer's could be within reach.
New Research Advances Genetic Studies in Wildlife Conservation
‘Next-gen’ DNA sequencing of non-invasively collected hair expands field of conservation genetics.
Skyscraper Banner

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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!