EraGen Biosciences and Bayer announce agreements for new cystic fibrosis (CF) assay

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.

“Current advancements in genetic and molecular diagnostics are transforming the realm of clinical laboratory medicine,” stated Tony Bihl, President of Bayer HealthCare’s Diagnostics Division. “Today’s laboratories face mounting pressure to keep pace with escalating testing demands, while supporting the novel testing needs of the healthcare enterprise. Automated, genetic diagnostics assays, including Cystic Fibrosis, are vital for the laboratory to take advantage of clinical progress, while maintaining lab efficiencies and providing timely, reliable clinical information.”

“We are excited to partner with Bayer HealthCare on the commercial expansion of our MultiCode product line. Bayer HealthCare previously licensed EraGen’s technology for use in its FDA approved HIV, HCV, and Hepatitis B Versant® assays. These new agreements with Bayer HealthCare further validate our novel technology and acknowledge our ability to develop fast and effective molecular diagnostic products. Bayer HealthCare and EraGen--an emerging fast paced developer--are two companies bringing individual strengths together to better serve the clinical diagnostic market and improve patient outcomes,” said Dr. Irene Hrusovsky, President and CEO of EraGen Biosciences.

“This new Cystic Fibrosis assay is only the first of a wide range of disease-specific MultiCode tests to come. This is a great day for EraGen,” said Dr. James Prudent, Chief Scientific Officer, at EraGen.