Hologic Gets CE Marks for Molecular Assays for Transplant Patients

Marlborough, Mass.-based Hologic has received CE marks for two new molecular tests, the Panther Fusion EBV Quant assay for Epstein-Barr virus and the Panther Fusion BKV Quant assay for BK virus.

The assays are intended to quantify the viral load of the respective viruses to help in managing solid organ transplants and hematopoietic stem cell transplant patients.

Epstein-Barr virus — also known as herpesvirus 4 — and BK virus are among the most common viral infections. Symptoms are generally mild to moderate, but the infections can be more serious for immunosuppressed patients who undergo transplants.

The EBV Quant assay analyzes blood and plasma samples, while the BKV Quant assay uses plasma and urine samples. Both tests run on the company’s Panther Fusion real-time polymerase chain reaction equipment.