News From Transplant Week of April 14, 2002 / Vol. 3 No. 15

 

FDA OKs New Method for Measuring Immune Response of Transplant Recipients

 

Cylex,Inc., announced FDA approval of the Cylex™ Immune Cell Function Assay, a new technology designed to more easily measure the immune response of organ-transplant recipients taking anti-rejection medications.

"This clearance is not only a major milestone for the company but physicians now have a method that allows them to rapidly assess an individual patient's immune status at any point in time," said Cylex President Judith A. Britz.

The Cylex assay uses only a small amount of whole blood and results are available within 24 hours rather than several days, a spokesperson said.

Dr. Adriana Zeevi of the University of Pittsburgh, one of the medical centers that took part in the clinical trials, said "the Cylex Immune Cell Function Assay can be considered as an in vivo bio-assay for drug activity and should be used as an adjunct to drug level monitoring post-transplantation along with other clinical indicators."

Other sources: Cylex