Molecular diagnostic company Mesa Biotech Inc reported on Tuesday the receipt of the CE Mark in the European Union (EU) for its Accula RSV Test for the Respiratory syncytial virus (RSV), an RNA virus attributable to outbreaks of respiratory tract infections.

Effective immediately, the company's RSV test will be marketed by select distributors in the EU. The Accula RSV Test is pending US FDA clearance in the US.

The company's Accula System, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. The Accula RSV test is indicated for use with nasal swab collection and provides a more comfortable specimen collection experience for the patient including children.

According to the World Health Organization (WHO), the global burden of RSV-associated acute lower respiratory infection is estimated at 33 million annually, resulting in more than three million hospitalisations and almost 60,000 in-hospital deaths in children under five years of age.