The cobas EBV is said to be the first quantitative in vitro diagnostic test for Epstein-Barr virus DNA in the US
Roche Diagnostics, Mannheim. (Credit: F. Hoffmann-La Roche Ltd.)
Roche has secured authorisation from the US Food and Drug Administration (FDA) for its cobas EBV quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA.
The authorisation enables healthcare professionals to use a quantitative in vitro diagnostic test, which is claimed to be the first of its kind, as a crucial tool to monitor transplant patients at risk for complications from infections or reactivations of EBV.
Epstein-Barr virus, a member of the herpes virus family, has been linked with a range of cancers in transplant patients such as post-transplant lymphoproliferative disorder (PTLD).
The cobas EBV is a PCR viral load test that runs on cobas 6800 and cobas 8800 systems
The cobas EBV is a polymerase chain reaction (PCR) viral load test, which runs on the fully automated and widely available cobas 6800 and cobas 8800 systems.
Roche’s test helps to provide results in international measures and allows laboratories from any place in the US to secure comparable results when measuring levels of EBV DNA.
With dual-target technology, the cobas EBV real-time PCR viral load test allows to deliver quantitative accuracy and protect against the risk of sequence variations that may be present in the Epstein-Barr virus.
According to the company, the cobas EBV test has coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL to 1E+08 IU/mL in EDTA plasma.
Serving as an alternative to lab-developed tests (LDTs) or assay specific reagents (ASR) combination, the test has the capacity to minimise variability and complexity in testing.
Earlier, the cobas EBV quantitative in vitro diagnostic test secured breakthrough device designation from the FDA.
The fully automated cobas 6800/8800 systems hold the capacity to deliver 96 results in around three hours.
The cobas 6800 system provides 384 results and the cobas 8800 system offers 1,056 results in an eight-hour shift, said the company.
Roche Diagnostics CEO Thomas Schinecker said: “Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients.
“The EBV test helps set a new standard of care for patients, as healthcare professionals now can act early in the management of this virus with best-in-class monitoring tools and can make more informed decisions when treating patients.”
In May this year, Roche secured EUA status from the FDA for its new Elecsys Anti-SARS-CoV-2 antibody test.