" "
Satellite Banner
Genomics
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 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 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
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.
Could the Food we Eat Affect Our Genes?
Almost all of our genes may be influenced by the food we eat, according to new research.
Neanderthal DNA Influences Human Disease Risk
Large-scale, evolutionary analysis compares genetic data alongside electronic health records.
Improving Regenerative Medicine
Lab-created stem cells may lack key characteristics, UCLA research finds.
Tick Genome Reveals Secrets of a Successful Bloodsucker
NIH has announced that decipher the genome of the blacklegged tick which could lead to new tick control methods.
"Dark Side" of the Transcriptome
New approach to quantifying gene "read-outs" reveals important variations in protein synthesis and has implications for understanding neurodegenerative diseases.
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.
New Source of Mutations in Cancer
Recently, a new mutation signature found in cancer cells was suspected to have been created by a family of enzymes found in human cells called the APOBEC3 family.
Advancing Synthetic Biology
Living systems rely on a dizzying variety of chemical reactions essential to development and survival. Most of these involve a specialized class of protein molecules — the enzymes.
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
2,900+ 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!