Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

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
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 2,600+ scientific posters on ePosters
  • More than 3,800+ 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 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 xTAG® CYP2C19 Kit
New cytochrome P450 2C19 assay helps physicians optimize individual patient care.
Tuesday, September 24, 2013
Luminex Announces Agenda for Planet xMAP USA Multiplexing Symposium
Keynote speakers include Dr. James Watson, Dr. Todd Golub and Ms. Linette Granen.
Wednesday, April 21, 2010
Luminex Receives 510(K) Clearance for new Cystic Fibrosis Test
New diagnostic test will be used in screening potential parents and to assist in screening newborns for genetic disease.
Friday, September 04, 2009
Luminex Corporation and Mingyuan Medicare Development Company Sign Distribution Agreement
The collaboration will introduce newborn screening products for genetic disorders in China and Hong Kong.
Friday, November 21, 2008
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 Corporation Places 5,000th Instrument
Luminex has recently delivered its 5,000th instrument to Beaumont Hospital in Royal Oak, Michigan.
Thursday, February 21, 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
New Gene Therapy for Vision Loss From a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
Five New Genetic Variants Linked to Brain Cancer Identified
The biggest ever study of DNA from people with glioma – the most common form of brain cancer – has discovered five new genetic variants associated with the disease.
Predictive Model for Breast Cancer Progression
Biomedical engineers have demonstrated a proof-of-principle technique that could give women and their oncologists more personalized information to help them choose options for treating breast cancer.
Fatty Liver Disease and Scarring Have Strong Genetic Component
Researchers say that hepatic fibrosis, which involves scarring of the liver that can result in dysfunction and, in severe cases, cirrhosis and cancer, may be as much a consequence of genetics as environmental factors.
Specific Variations in RNA Splicing Linked to Breast Cancer
Researchers have identified cellular changes that may play a role in converting normal breast cells into tumors. Targeting these changes could potentially lead to therapies for some forms of breast cancer.
Finding Links and Missing Genes
A catalogue of large-scale genetic changes around the world.
Scientists Test New Gene Therapy for Vision Loss from a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
Gene Expression: A Snapshot of Stem Cell Development
New genes found that regulate development of stem cells.
Assessing Cancer Patient Survival and Drug Sensitivity
RNA editing events another way to investigate biomarkers and therapy targets.
A Natural History of Neurons
Diverse mutations reveal lineage of brain cells.
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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos