Hologic Gains CE Mark for Two Devices

Hologic has gained CE mark certifications for two of its devices, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and the Novodiag RESP-4 molecular diagnostic test.

Both assays use nasopharyngeal swab samples to detect and differentiate four of the most prevalent respiratory viruses that can present with similar clinical symptoms, which are SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus.

“The ability to accurately differentiate between respiratory viruses with similar symptoms is essential if physicians are to ensure optimized care for each patient,” the company said.

Marlborough, Mass.-based Hologic is primarily focused on products for women’s health, including breast and skeletal health and GYN surgical health, with an emphasis on early detection and treatment.