Karius gets FDA breakthrough device designation for infectious disease test

Lung Virus Bacteria Social

Karius announced today that its Karius Test for the diagnosis and management of lung infections in immunocompromised patients has been granted breakthrough device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).

The Redwood City, CA-based Karius says that the liquid biopsy-based test helps diagnose pneumonia, endocarditis, invasive fungal disease, febrile neutropenia, and fever of unknown origin in immunocompromised patients.

“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 Dr. Brad Perkins, chief medical officer of Karius. 

Earlier this month, Karius raised $100 million in a series C financing round; the company said that it intended to use the funds to expand the number of hospitals using the Karius test, as well as to address the demand for access to the diagnostic beyond the hospital setting. The firm added that it planned to explore additional applications for its microbial cell-free DNA technology.

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