Hologic, Inc., based in Massachusetts, recently confirmed its European CE marking for two new molecular assays, Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay, according to a press release.
“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 health care providers can quantitate and monitor for their presence,” group president, International at Hologic, Jan Verstreken, said in the release. “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 addition is intended to transform its pathogen monitoring menu on the Panther Fusion system into assays that can identify the respective viruses that are meant to leverage existing diagnosis and management treatments relating to solid organ transplant patients and hematopoietic stem cell transplant patients.
The two representations consist of vitro nucleic acid amplification tests (NAAT) “that are run on the fully automated Panther Fusion system using real-time Polymerase Chain Reaction (PCR) technology,” a press release states. “The Panther Fusion EBV Quant is validated for use with whole blood and plasma samples.”
The Panther Fusion BKV Quant is proved to efficiently use human plasma and urine samples to match “viral levels that are accurately quantitated in transplant recipients to guide treatment decisions and monitor response to therapy,” the press release explains.
“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,” Verstreken said in the release.