Luminex's New Cystic Fibrosis Test - Analyst Blog

Luminex Corporation (LMNX), a developer of biological testing technologies, has commenced the commercial launch of its new cystic fibrosis (a genetic disorder) diagnostic test dubbed “xTAG Cystic Fibrosis 60 Kit v2” following its recent approval by the U.S. Food and Drug Administration (FDA). The product will be marketed throughout the U.S. through Luminex Molecular Diagnostics (LMD), a unit of the company’s Assay segment.

Cystic fibrosis, which afflicts roughly 30,000 people in the U.S., is an inherited disease of the mucus glands. The condition affects many body systems, including progressive damages to the lungs and complications in the digestive system. Early prognosis of cystic fibrosis is vital as it reduces the patient’s therapeutic needs, lowers medical complications and increases life expectancy.

The xTAG test kit, which is one of the cystic fibrosis tests developed by Luminex, is the most comprehensive and flexible test approved by the FDA for this condition. It has been designed for use by the physicians in confirmatory diagnostic testing in newborns and children and screening of parents to detect whether they are potential carriers of cystic fibrosis-causing gene mutations.

The novel test can simultaneously screen up to 60 cystic fibrosis-causing genetic mutations from a single blood sample in about an hour. Besides it offers the physicians the flexibility to choose the type of mutations for testing.

Texas-based Luminex develops, manufactures and markets proprietary biological testing technologies, which has applications across the life sciences industry. Its proprietary open-architecture 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, which are expected to support growth, moving forward. The company continues to expand its xMAP technology-based installed instrument base. Luminex is also spending heavily on assay developments, with some exciting assay products (including NeoPlex 4 and RVP FAST) currently awaiting FDA clearance.

Moreover, Luminex has a strong international presence, which is helping it to broaden product range and customer base. However, it operates in the highly competitive life sciences industry, characterized by rapid and continuous technological innovation. We are currently Neutral on Luminex.
 
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