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REDWOOD CITY, Calif.--(BUSINESS WIRE)--Karius®, Inc., a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (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,” stated Brad Perkins, M.D., Chief Medical Officer of Karius. “As noted in the American Thoracic Society (ATS) Workshop Report for Immunocompromised Host Pneumonia: Definitions and Diagnostic Criteria,1 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.”. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these innovative medical devices

InnovationRx is your weekly digest of healthcare news. To get it in your inbox, subscribe here. A protein folding prediction in response to a small molecule generated by AlphaFold 3.Isomorphic LabsToday, Deepmind announced the launch of AlphaFold 3, the next generation of its AI software for structural biology, which has enabled thousands of researchers to predict the complicated chemical interactions involved with proteins. One major difference in the new iteration of the program: instead of just predicting protein folding, it predicts the interactions of other biological molecules as well including DNA, RNA and small molecules. The company published the accuracy of its predictions in the journal Nature.In addition to the new capabilities–which even includes the ability to make predictions based on epigenetic changes to DNA–the company has also launched AlphaFold Server, a web service that enables researchers to generate biochemical models without having to install the system itself from open source code, as was the case with previous iterations. Something else new is that AlphaFold now works with diffusion models – which are popularly known for being used by AI systems that generate images from text prompts – in place of some of its previous structural models.“The response to AlphaFold 2 was more than I could have ever imagined in terms of the kind of creativity and what the research community has done with it,” Deepmind research director John Jumper said at a press briefing