Digene acquires rights to cystic fibrosis screening products

Asuragen, a newly formed molecular diagnostic company and formerly a division of Ambion, has received an up-front payment from Digene and will receive additional payments based on regulatory milestones. More specific financial details of the agreement were not disclosed.

Digene will have the exclusive rights to market and distribute Asuragen’s Signature cystic fibrosis (CF) products worldwide.

In addition, Asuragen will develop, also for Digene’s exclusive distribution, the next generation CF test which expands the mutation panel to include ethnic-specific mutations that can be adapted for use in carrier screening and may find additional utility for neonatal and newborn testing.

Digene will also have the first right of refusal on future genetic test products developed by Asuragen.

In April 2001, the American College of Medical Genetics and the American College of Obstetricians and Gynecologists issued statements and developed guidelines for population CF carrier screening. It was recommended that genetic screening for CF mutations should be offered to identify carriers among adults with a positive family history of CF, partners of individuals with CF, couples currently planning a pregnancy and couples seeking prenatal care.

“The expertise of Digene’s extensive sales force will greatly expand the reach of Asuragen’s Signature genetic testing products into the testing community, which will provide increased opportunities to affect patient care,” commented Matt Winkler, CEO of Asuragen.