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

REDWOOD CITY, Calif., May 16, 2024Karius®, 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.

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 that 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, MD; former Director of the National Cancer Institute and Acting Commissioner of the Food and Drug Administration, and member of the Karius board.

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.

To learn more about Karius Test diagnostic applications for infectious disease, including pneumonia, endocarditis, invasive fungal disease, febrile neutropenia, and fever of unknown origin, visit us at kariusdx.com.

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

About Karius
Karius Inc., a global leader in genomic diagnostics for infectious diseases, harnesses metagenomics, next-generation sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis.

Karius Test® is a Laboratory Developed Test (LDT) performed in a CLIA-certified and CAP-accredited laboratory to perform high-complexity clinical laboratory testing. The Karius Test®, used in over 400 healthcare institutions across the United States, 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 that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification.

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