Hologic (HOLX) Granted European CE Mark for Molecular Assays

Hologic, Inc. (Nasdaq: HOLX) announced it has received CE marking for two new molecular assays, Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay, expanding its transplant pathogen monitoring menu on the Panther Fusion system. The assays quantify the viral load of the respective viruses and are intended to aid the diagnosis and management of solid organ transplant patients and hematopoietic stem cell transplant patients.

The assays are in vitro nucleic acid amplification tests (NAAT) that are run on the fully automated Panther Fusion system using real-time Polymerase Chain Reaction (PCR) technology. The Panther Fusion EBV Quant is validated for use with whole blood and plasma samples. The Panther Fusion BKV Quant is validated for use with human plasma and urine samples. Plasma, whole blood and urine specimens are important biomarkers when using quantitative NAATs for diagnosis and management of transplant patients. It is crucial that viral levels are accurately quantitated in transplant recipients to guide treatment decisions and monitor response to therapy.1,2

“Immunocompromised patients are vulnerable to a range of infections. As both the Epstein-Barr virus (EBV) and the BK virus (BKV) are extremely common and mainly asymptomatic, it is important that healthcare providers can quantitate and monitor for their presence,” said Jan Verstreken, Group President, International at Hologic. “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.”

“These two assays represent two firsts for us. They are the first quantitative assays developed for the Panther Fusion system, further expanding our existing portfolio of diagnostic and viral load tests. They are also the first Panther Fusion assays developed in our R&D facility in Liege, Belgium, which we acquired last year,” concluded Verstreken.

For more information on the Aptima and Panther Fusion assays, visit www.hologic.com.

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