EraGen Biosciences, a rapidly growing molecular diagnostics company and Bayer HealthCare LLC, Diagnostics Division, announced today that EraGen has licensed its patented MultiCode-PLx® System to Bayer HealthCare in an exclusive worldwide agreement for Cystic Fibrosis. Bayer HealthCare will provide laboratories with a rapid, easy-to-use Cystic Fibrosis assay capable of being automated for mutation carrier screening, as well as for neonatal and newborn testing.
The agreement also provides Bayer HealthCare with additional rights enabling Bayer HealthCare to expand its presence in the genetics-based diagnostics testing market with a number of assays for other disease states.
Cystic Fibrosis and the Importance of Genetic Codes
Understanding variations in the human genetic code is vital to the development of new medical diagnostic and therapeutic products. Genetic tests look for abnormalities in a person’s genes. According to the Cystic Fibrosis Foundation, Cystic Fibrosis is a genetic disease affecting about 30,000 children and adults in the United States with more than 1,000 new cases each year. It affects some 60,000 individuals worldwide.
Cystic Fibrosis is the most common inherited (autosomal recessive) disease in the Caucasian population. The disease is characterized by the body’s production of abnormally thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections. These thick secretions also obstruct the pancreas, preventing digestive enzymes from reaching the intestines to help break down and absorb food. Additional complications later in life include diabetes and osteoporosis. The median life expectancy of those individuals diagnosed with Cystic Fibrosis is the early-30’s.
If a child inherits a defective gene from only one parent, the child will be an asymptomatic carrier of the disease gene. More than 10 million Americans, one in every 31, are asymptomatic carriers of the defective gene, according to the American College of Obstetricians and Gynecologists. If the child inherits two defective genes (one from each parent), then the child will have Cystic Fibrosis.
EraGen’s MultiCode-PLx platform is an extremely cost-effective, high throughput genotyping system that simultaneously tests for predetermined mutations of the gene associated with Cystic Fibrosis, the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Leveraging isobases, the test substantially reduces the time for cystic fibrosis multi-mutation analysis when compared to other testing systems currently available. The MultiCode-PLx System allows Bayer HealthCare’ customers to enhance their level of Cystic Fibrosis clinical testing by reducing errors, providing faster turn around times and decreasing labor requirements.