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Hologic Obtains CE Mark for Molecular Epstein-Barr, BK Virus Assays

NEW YORK ─ Hologic announced Wednesday it has obtained CE marking for its Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay, expanding its transplant pathogen monitoring menu on the automated, real-time PCR Panther Fusion system.

The nucleic acid amplification tests quantify the viral load of the Epstein-Barr and BK viruses and are intended to aid in the diagnosis and management of solid organ transplant patients and hematopoietic stem cell transplant patients, the firm said.

The Panther Fusion EBV Quant is validated for use with whole blood and plasma samples, and the Panther Fusion BKV Quant is validated for use with human plasma and urine samples.

Hologic noted it is crucial that viral levels are accurately quantitated in transplant recipients to guide treatment decisions and monitor response to therapy.

"As both the Epstein-Barr virus and the BK virus are extremely common and mainly asymptomatic, it is important that healthcare providers can quantitate and monitor for their presence," Jan Verstreken, Hologic group president, international, said in a statement. "These assays, along with our Aptima CMV Quant assay that we launched in Europe last year, provide our laboratory partners with the tools they need to accurately assess transplant patient samples quickly and confidently."

The two tests are the first quantitative assays developed for the Panther Fusion system and the first Panther Fusion assays developed in the Hologic R&D facility in Liege, Belgium, which it acquired last year, Verstreken added.