Karius Test® Receives FDA Breakthrough Device Designation to Aid in the Diagnosis of Infectious Disease

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 avai