Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
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 3,200+ scientific posters on ePosters
  • More Than 4,700+ 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 Receives CE-IVD Mark
Company has announced that it has received CE-IVD mark for ARIES® Flu A/B & RSV Assay.
Thursday, June 02, 2016
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 Corporation Begins Clinical Trials for ARIES™ GBS Assay
Company expects its FDA submission for the ARIES platform in the summer of 2015.
Tuesday, June 09, 2015
Luminex Corporation Reports First Quarter 2015 Results
Company announces financial and operating highlights.
Tuesday, May 12, 2015
Luminex Corporation Provides Updates on ARIES® Clinical Trials
Clinical trials initiated for ARIES® Clostridium difficile assay.
Friday, May 01, 2015
Luminex Begins Clinical Trials for ARIES® System and ARIES® HSV 1&2 Assay
Company plans to seek both FDA clearance and CE IVD marking this year.
Tuesday, March 31, 2015
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
Scientific News
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Some Women With PCOS May Have Adrenal Disorder
Researchers at NIH have found that a subgroup of women with PCOS, a leading cause of infertility, may produce excess adrenal hormones.
Alzheimer's Genetics Point To New Research Direction
A University of Adelaide analysis of genetic mutations which cause early-onset Alzheimer’s disease suggests a new focus for research into the causes of the disease.
Penn State, TB Alliance, and GSK Partner To Discover New Treatments For TB
A new collaboration between TB Alliance, GSK, and scientists in the Eberly College of Science seeks to find new small molecules that can be used to create antibiotics in the fight against tuberculosis (TB).
Manufactured Stem Cells To Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Faster Detection of Pathogens in the Lungs
Thanks to new molecular-based methods, mycobacterial pathogens that cause pulmonary infections or tuberculosis can now be detected much more quickly.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Scroll Up
Scroll Down
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!