US-based Hologic has secured a CE mark for its two new molecular assays, Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay, for use with transplant patients.
The new tests for Epstein – Barr virus and BK virus expand the Panther Fusion transplant pathogen monitoring portfolio of Hologic.
Hologic designed the assays to aid in the diagnosis and management of solid organ transplant and hematopoietic stem cell transplant patients by quantifying the viral load of the corresponding viruses.
The in vitro nucleic acid amplification tests (NAAT) are performed using real-time Polymerase Chain Reaction (PCR) technology based on the Panther Fusion system.
According to the firm, Panther Fusion EBV Quant has been tested on whole blood and plasma samples.
The human plasma and urine samples have been validated for use with the Panther Fusion BKV Quant.
Hologic said that when using quantitative NAATs for transplant patient diagnosis and management, plasma, whole blood, and urine specimens are significant biomarkers.
To guide treatment decisions and evaluate response to therapy, it is critical to correctly quantify viral levels in transplant patients, said the company.
Hologic International group president Jan Verstreken said: “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.”
Verstreken added: “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.”
