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