Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG® CYP2C19 Kit

Luminex Corporation Receives FDA and European Clearance for a New Personalized
                 Medicine Genotyping Assay, xTAG® CYP2C19 Kit

New Cytochrome P450 2C19 Assay Helps Physicians Optimize Individual Patient

PR Newswire

AUSTIN, Texas, Sept. 23, 2013

AUSTIN,Texas, Sept. 23, 2013 /PRNewswire/ --Luminex Corporation(NASDAQ:
LMNX) today announced it has received U.S.FDAand 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," saidPatrick J. Balthrop, president and chief
executive officer of Luminex. "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

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.^1 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

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.

More information on xTAG CYP2C19 Kit v3 can be found at

AboutLuminex Corporation:
Luminexis committed to applying its passion for innovation toward creating
breakthrough solutions to improve health and advance science. The company is
transforming global healthcare and life-science research through the
development, manufacturing and marketing of proprietary instruments and assays
utilizing xMAP® open-architecture multi-analyte platform,MultiCode®real-time
polymerase chain reaction (PCR), and multiplex PCR-based technologies, that
deliver cost-effective rapid results to clinicians and researchers.Luminex's
technology is commercially available worldwide and in use in leading clinical
laboratories, as well as major pharmaceutical, diagnostic, biotechnology and
life-science companies. Luminexis meeting the needs of customers in markets
as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical
research including genomic and proteomic research, personalized medicine,
biodefense research and food safety. For further information onLuminex
Corporationand the latest advances in multiplexing using award winning
technology, please visit


1. FAERS Domestic and Foreign Reports by Year. FDA. (internet). 2012 June 30;
cited 2013 June 24. Available from:

2. Medication Safety Basics. CDC (Internet). Cited 2013 June 24. Available


Luminex Investor Contact
Harriss Currie, 512.219.8020
Sr. Vice President of Finance and CFO

Luminex Media Contact
Mimi Torrington, 512.219.8020
Director of Marketing Communications

SOURCE Luminex Corporation

Press spacebar to pause and continue. Press esc to stop.