Luminex Corporation Receives Health Canada Approval for its Comprehensive Genotyping Assay, xTAG® CYP2D6 Kit v3

AUSTIN, Texas, Jan. 28, 2015 /CNW/ -- Luminex Corporation (NASDAQ: LMNX) announced it has received a Health Canada Class 3 Device License approval for its comprehensive genotyping assay, xTAG® CYP2D6 Kit v3. Identification of patient CYP2D6 genotypes can help clinicians individualize drug treatment by selecting appropriate therapies.

Cytochrome P450 2D6 (CYP2D6) is a clinically important gene that encodes a drug-metabolizing enzyme. CYP2D6 metabolizes greater than 25% of the drugs in use today including some cardiovascular and anti-cancer drugs, anti-psychotics, anti-depressants, pain-medications, beta blockers, and antiarrhythmics.

Variations in the CYP2D6 gene can result in distinct drug metabolizing profiles leading to potentially sub-optimal drug responses, such as drug toxicity, adverse drug reactions (ADRs), or inadequate therapeutic effect. Approximately 1.6% of patients admitted to acute care hospitals in Canada experience a serious adverse drug reaction. With almost 2.5 million annual hospital admissions in Canada of the type studied, statistics suggest that an estimated 40,000 serious adverse drug reactions occur annually in Canadian acute care hospitals.¹

xTAG CYP2D6 Kit v3 is an in vitro diagnostic assay that analyzes a patient's CYP2D6 genotype from DNA extracted from a blood sample and is used 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.

Additionally, another pharmacogenetic assay by Luminex, xTAG CYP2C19 Kit v3, received Health Canada approval in 2014. The CYP2C19 enzyme is responsible for metabolizing a variety of drugs used to treat ulcers, seizures, malaria, anxiety, and some antidepressants.

More information on Luminex's pharmacogenetic products, xTAG CYP2D6 Kit v3 and xTAG CYP2C19 Kit v3, can be found at www.luminexcorp.com/CYP2D6, www.luminexcorp.com/CYP2C19.

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. Cadario B. New appreciation of serious adverse drug reactions. BCMJ (Internet). Cited 2014 December. Available from: http://www.bcmj.org/bc-centre-disease-control/new-appreciation-serious-adverse-drug-reactions.

Contacts

Luminex Corporate Contact:
Harriss Currie
Sr. Vice President, Finance and CFO
[e-mail]
512.219.8020

Luminex Media Contact:
Christine Valle
Sr. Manager, Global Marketing
[e-mail]
512.219.8020

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SOURCE Luminex Corporation

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