AUSTIN, Texas, Nov. 17, 2010 /PRNewswire-FirstCall/ -- Luminex
Corporation (Nasdaq: LMNX), today announced that it has
commercially launched its first pharmacogenetic test, the xTAG®
CYP2D6 Kit, which recently received 510(k) clearance from the U.S.
Food and Drug Administration (FDA). The new test enables a
personalized medicine approach to help physicians manage patients
for whom they may prescribe certain drugs that are metabolized by
the enzyme cytochrome P450 2D6.
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"The xTAG CYP2D6 Kit will be an important tool in the
fast-growing field of personalized medicine," said Patrick J. Balthrop, president and CEO of
Luminex. "The first innovation in CYP2D6 diagnostics in five years,
it combines the power of multiplexing with the promise of
pharmacogenetics. The information it provides has significant
potential to help doctors improve care by assisting them in
determining the best therapeutic strategy for an individual
patient."
CYP2D6 is an enzyme that is involved in the metabolism of
approximately one quarter of all prescription drugs, including
betablockers, opiates, selective serotonin reuptake inhibitors
(SSRIs), tricylic antidepressants (TCAs), neuroleptics and
antiarrhythmics. People may carry a slow- or fast–acting form of
the enzyme while others have a non-functional version of the CYP2D6
gene, or allele, which can affect how an individual's body responds
to these therapies.
The xTAG CYP2D6 Kit helps identify individuals who possess both
common and rare CYP2D6 poor-metabolizer variants. Abnormal
metabolizers are more likely to experience adverse drug reactions
from medications acted upon by CYP2D6 and can be at increased risk
of dangerous drug-induced side effects, drug interactions and
therapeutic failure. These individuals may need to receive
alternative treatment doses and undergo drug level monitoring.
"The clinical utility of CYP2D6 genotyping is very important and
diverse, as the enzyme metabolizes nearly 25 percent of all
medications used across a myriad of medical disciplines. Combined
with 10 percent poor-metabolizer phenotype in the general
population, it dictates a critical need for the availability of
high quality CYP2D6 genotyping," said Kristen Reynolds, PhD, vice president of
Laboratory Operations, PGXL Laboratories. "The xTAG CYP2D6 assay
from Luminex provides our lab with a robust multiplex assay, which
allows for higher throughput, shorter turnaround times, and less
per-sample cost than previous CYP2D6 genotyping technologies."
The xTAG CYP2D6 Kit is the second test of its kind to be cleared
by FDA. It is a qualitative genotyping assay that can
simultaneously detect and identify a panel of single-nucleotide
polymorphism (SNP) variants found within the CYP2D6 gene. It also
identifies gene rearrangements associated with deletion and
duplication genotypes.
The xTAG CYP2D6 assay features a simple laboratory workflow and
provides accurate results in 8 hours. It is based on Luminex's
flexible xMAP® Technology and is designed to be used on the widely
distributed Luminex 200 system. It is uniquely suited for
laboratories that offer cytochrome P450 drug metabolism testing
services to physicians including psychiatrists, hospital
pharmacologists, oncologists and general practitioners, who may
treat patients with medical therapies that are metabolized all or
in part by CYP2D6.
The first in a line of CYP products Luminex is developing; the
xTAG CYP2D6 Kit is now commercially available from Luminex
Molecular Diagnostics and its distribution partner, Fisher
HealthCare.
The xTAG CYP2D6 Kit is not indicated for stand-alone diagnostic
purposes and is not intended to be used to predict drug response or
non-response.
For more information, call 512.219.8020, or visit
www.luminexcorp.com.
About Luminex Corporation
Luminex Corporation develops, manufactures and markets
proprietary biological testing technologies with applications
throughout the diagnostic and life sciences industries. The
Company's xMAP® multiplex solutions include an open-architecture,
multi-analyte technology platform that delivers fast, accurate and
cost-effective bioassay results to markets as diverse as
pharmaceutical drug discovery, clinical diagnostics and biomedical
research, including the genomics and proteomics markets. The
Company's xMAP technology is sold worldwide and is already in use
in leading clinical laboratories as well as major pharmaceutical,
diagnostic and biotechnology companies. Further information on
Luminex Corporation or xMAP can be obtained at
www.luminexcorp.com.
Luminex Investor Contact:
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Matt Scalo, Senior Director of
Investor Relations
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512.219.8020
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mscalo@luminexcorp.com
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Luminex Media Contacts:
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Mimi L. Torrington, Director of
Marketing Communications
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512.219.8020
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mtorrington@luminexcorp.com
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Brandon Brunson
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512.241.2234
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Brandon.Brunson@porternovelli.com
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SOURCE Luminex Corporation