Lab21 launches cytomegalovirus test for blood transfusions
This article was originally published in Clinica
Executive Summary
Lab21 has launched a test for cytomegalovirus (CMV) in human serum and plasma. The enzyme immunoassay, now available worldwide excluding the US, is intended to screen donated blood for the virus, minimising the risk of transmission. It is "significantly more sensitive than other CMV assays that are currently commercially available", Cambridge, UK-based Lab21 claims. CMV, from the herpes family of viruses, generally causes very few symptoms or none at all. However, it can lead to significant health problems in immunocompromised people, such as HIV patients or transplant recipients, and foetuses. The company CE marked the diagnostic on November 13, and plans to seek US FDA 510(k) approval "in due course", a spokesperson told Clinica.