FDA Awards Breakthrough Device Designation to the Karius Test

Karius Inc.’s Karius Test has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. The authorization allows the test to be used for diagnosiing and managing lung infections, including lower respiratory infections and pneumonia.
 
“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,” Karius Chief Medical Officer Brad Perkins, M.D., said. “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 FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effectively treating or diagnosing a life-threatening or irreversibly debilitating disease or condition. The program aims to expedite the development and review of these medical devices.
 
Clinical data that support the use of the Karius Test in pneumonia for immunocompromised patients includes the results of the PICKUP study, where results showed the Karius Test increased the relative yield for detection of a probable cause for pneumonia by 40%.² Additionally, the Karius Test identified clinically relevant non-pneumonia infections in 39% of subjects.² These additional data highlight the ATS Workshop Report observation that “the existing clinical definition of pneumonia is syndromic and lacks specificity,”¹ and support the value of approaches that are agnostic to both the pathogen and the site of infection like the Karius Test.
 
“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, M.D., former director of the National Cancer Institute, former acting FDA commissioner, and Karius board member.
 
Karius Inc. harnesses metagenomics, next-generation sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test is a Laboratory Developed Test performed in a CLIA-certified and CAP-accredited laboratory to perform high-complexity clinical laboratory testing. Used in more than 400 healthcare institutions across the United States, the test identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt. A landmark study in the Journal of Clinical Microbiology found the Karius Test detected 701 unique microbial taxa across a 15,000-patient cohort, making it the largest study of its kind.

References 
¹ Cheng et al, Annals of the American Thoracic Society, 2023
² Bergin SP, et al. Clinical Infectious Diseases. October 2023