AUSTIN, Texas, Sept. 23, 2013
/PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today
announced 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.
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"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. "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 2011.1
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 preventable.2
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
www.luminexcorp.com/2C19.
About Luminex Corporation:
Luminex is
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. Luminex is 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 on Luminex
Corporation and the latest advances in multiplexing using
award winning technology, please
visit http://www.luminexcorp.com/.
Sources:
1. FAERS Domestic and Foreign Reports by Year. FDA. (internet).
2012 June 30; cited 2013 June 24. Available from:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070441.htm
2. Medication Safety Basics. CDC (Internet). Cited 2013 June 24.
Available from: http://www.cdc.gov/medicationsafety/basics.html
Contacts:
Luminex Investor Contact
Harriss Currie, 512.219.8020
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
Luminex Media Contact
Mimi Torrington, 512.219.8020
Director of Marketing Communications
mtorrington@luminexcorp.com
SOURCE Luminex Corporation