5AM Ventures’ Post

We’re thrilled to announce that the #KariusTest has been granted designation as a Breakthrough Device from the FDA for use in the diagnosis and management of immunocompromised patients with suspected lung infections, including lower respiratory infection and pneumonia. “The Karius Test is commercially available nationwide as a laboratory developed test. We are seeking FDA marketing authorization of the Karius Test for lung infections in immunocompromised patients because improved diagnostic tests are urgently needed for these patients,” said Brad Perkins, our Chief Medical Officer. As noted in the American Thoracic Society Workshop Report for Immunocompromised Host Pneumonia: Definitions and Diagnostic Criteria, lung infections have high morbidity and mortality in immunocompromised patients, which is why advances in technologies like metagenomic sequencing used for the Karius Test are vital in improving the diagnosis and treatment of these patients.” New data on the Karius Test and cost-effectiveness in pneumonia will be presented at #ATS2024. https://hubs.li/Q02xnTnm0 #FDA #pneumonia #infectiousdiseases #metagenomic #breakthroughdevice