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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
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