Luminex Corporation licenses cystic fibrosis gene patent from John Hopkins

Luminex Corporation has announced that it has acquired a non-exclusive license from The Johns Hopkins University for the rights to use the university's patented cystic fibrosis genetic markers in the company's molecular diagnostic products sold in the United States.

Rights to use the genetic markers will be included with Tag-It(TM) cystic fibrosis products, which are available from Luminex's new division, Luminex Molecular Diagnostics (formerly Tm Bioscience), and extend to the company's distributors and end-user customers.

"These genetic markers from John Hopkins are an important element in advancing the diagnosis and monitoring of cystic fibrosis," said Jeremy Bridge-Cook, Vice President of Luminex Molecular Diagnostics. "We are pleased to be able to provide our customers and distributors with the rights to these markers as part of our Tag-It(TM) Cystic Fibrosis Kit."

Cystic fibrosis (CF) is the most common autosomal recessive disorder in the Caucasian population. It is a chronic disease that affects the lungs and digestive system and can be found in more than 30,000 children and adults in the United States and 70,000 children and adults worldwide.

The Tag-It(TM) Cystic Fibrosis Kit aids in newborn screening and confirmatory CF diagnostic testing in newborns and children and can determine CF carrier status in adults. The kit simultaneously screens for the 23 cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations and 4 variants (polymorphisms), as recommended by the American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG) in 2004. It also screens for 16 additional CFTR mutations prevalent in North America or the world.

The license from Johns Hopkins provides Tag-It(TM) CF Kit users and distributors rights to 4 mutations (549N, 551D, 553X, 559T) tested for in the kit and covers 2 mutations (553X and 551D) in the screening panel of 23 cystic fibrosis gene mutations recommended by ACMG and ACOG.

Performance testing has shown that the Tag-It(TM) CF Kit operates with 100 percent accuracy and greater than 99.9 percent reproducibility and precision. The kit is the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration (FDA) as an in vitro device for diagnostic use in the United States. It has also received CE mark certification and Health Canada clearance, allowing the test to be marketed for diagnostic purposes in the European Union and Canada.

Luminex Molecular Diagnostics was created in March 2007 when Luminex acquired Tm Bioscience of Toronto, Canada. This division of Luminex Corporation specializes in DNA-based research and diagnostics and is focused specifically on the design, development, manufacture and commercialization of nucleic-acid based testing products for genetic testing, personalized medicine and infectious disease.