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CareDx HLA Typing Dx Receives CE Mark

NEW YORK (GenomeWeb) – Molecular diagnostics developer CareDx announced today that its real time human leukocyte antigen (HLA) typing diagnostic Olerup QType has received CE marking.

Olerup QType provides tissue typing laboratories with real-time HLA typing of donors and recipients of organ transplants. The test can be performed within one hour, which the company claims is faster than any other similar product currently available, and can be performed on the Roche LightCycler and Applied Biosystems' platforms.

"We are excited to announce this milestone of broad commercialization of Olerup QType," CareDx CEO Peter Maag said in a statement. "Between the CE mark and launch on both PCR platforms, HLA laboratories across the world will have access to the fastest typing solution. With 50 percent of transplant labs worldwide using Olerup products today, we will continue to utilize our current relationships to provide this innovative solution."

On a call with analysts following the release of CareDx's fourth quarter earnings report in March, Maag said the firm anticipated receiving CE marking for the Olerup QType as well as revenues from Olerup testing done on both the Roche and Applied Biosystems platforms in the first half of 2018.