The FDA granted the Karius Test a breakthrough device designation 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, MD, the chief medical officer of Karius. “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” (Ann Am Thorac Soc 2023;20[3]:341-353).
Clinical data that support the use of the Karius Test in pneumonia for immunocompromised patients includes the results of the PICKUP study, in which results showed that the Karius Test increased the relative yield for detection of a probable cause for pneumonia by 40%. Additionally, the Karius Test identified clinically relevant non-pneumonia infections in 39% of subjects. New data from the PICKUP study on the cost-effectiveness of the Karius Test will be presented at the American Thoracic Society Annual Meeting 2024 International Conference.
“Recent data from several trials indicate that the Karius Test offers a speedy, accurate and sensitive diagnosis of infectious causes of pneumonia and related infections in immunocompromised patients. As such, it represents a major advance in the care of patients with hematologic cancers and those undergoing stem cell transplantation,” said Norman E. Sharpless, MD, the former director of the National Cancer Institute and acting commissioner of the FDA, and a member of the Karius board.
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide more effective diagnosis or treatment 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.
For more information, visit kariusdx.com.
From company press materials.
