New Diagnostic Test from Luminex - Analyst Blog

Luminex Corporation (LMNX), a developer of biological testing technologies, has commenced the commercial launch of its first pharmacogenetic test following its recent approval by the U.S. Food and Drug Administration (FDA). Pharmacogenetics is the study of genetic factors that influence an individual's response to drugs.

The test, dubbed the xTAG CYP2D6 Kit, has been designed to bring in the personalized medicine approach by helping physicians to identify and manage patients for whom they may prescribe therapies which are metabolized by the cytochrome P450 2D6 (CYP2D6) enzyme. The xTAG CYP2D6 Kit will be marketed throughout the U.S. through Luminex Molecular Diagnostics (“LMD”), a unit of the company's Assay segment.

The CYP2D6 enzyme is involved in the metabolism of many prescription drugs. A segment of the population may carry a slow-acting or fast-acting form of the enzyme while others could have a non-functional form, thereby affecting how individuals respond to treatments. People carrying a non-functional version of CYP2D6 are at high risk of adverse drug reactions when they take multiple therapies.

The xTAG CYP2D6 Kit helps physicians identify people who possess the CYP2D6 poor metabolizer variant and are at an elevated risk of adverse drug-induced side-effects and treatment failure. Physicians may prescribe alternative treatment doses and monitor drug levels for individuals with this genetic variant.

The xTAG CYP2D6 is the second test of its kind approved in the U.S. The test leverages Luminex's proprietary open-architecture xMAP technology and is intended to be used with the company's Luminex 200 analytical system. The test has been fine tuned to meet the requirement of laboratories which provide CYP2D6 metabolism testing services to physicians.

The xTAG CYP2D6 possesses the ability to simultaneously detect and identify a host of single-nucleotide polymorphism (SNP) variants found within the CYP2D6 gene. SNP is the most frequent genetic variation in people.The test provides accurate results in 8 hours.

Texas-based Luminex develops, manufactures and markets proprietary biological testing technologies, which have applications across the life sciences industry. Its xMAP technology enables fast, cost-effective and accurate conduct and analysis of biological tests (bioassays).

Luminex has an extensive product portfolio and a healthy pipeline. Moreover, the company continues to expand its xMAP technology-based installed instrument base and has a strong international presence.

However, Luminex operates in the highly competitive life sciences industry, characterized by rapid and continuous technological innovation. The company competes with Affymetrix (AFFX), Life Technologies (LIFE) and Sequenom (SQNM). Moreover, Luminex heavily depends on its partners to market its instruments and assays, a strategy that has inherent risks.

Moreover, Luminex is susceptible to regulatory delays and demand for research and diagnostics applications is expected to remain lackluster over the next few quarters given the soft macroeconomic backdrop.We currently have an Underperform rating on Luminex.

 
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