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Novacyt Gets CE Marks for BK, Epstein-Barr Tests

NEW YORK (GenomeWeb) — French diagnostics firm Novacyt announced today that it has received CE marking for its Genesig BK virus (BKV) and Epstein-Barr virus (EBV) diagnostic kits, which are designed for use in post-transplantation and immunosuppressed patients.

BKV is a polyomavirus that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic cell transplantation. EBV is a gamma herpesvirus that has been associated with a range of cancers such as post-transplant lymphoproliferative disorder.

The newly launched RT-PCR-based kits run on the Roche LightCycler 48 instrument. The BKV kit detects viral DNA in blood plasma and urine, while the EBV kit uses blood plasma or whole blood.

Novacyt, which launched a molecular diagnostic for Zika infection in 2017, said it is currently developing a cytomegalovirus infection test for use in post-transplant patients that is expected to launch next year. Earlier this month, the firm disclosed that it plans to divest its Novaprep cytology and clinical laboratory operations in order to focus on in vitro diagnostic product development and its diagnostic reagent businesses.