The test was granted FDA Breakthrough Device status for its potential to improve the diagnosis of lung infections in immunocompromised patients.

RT’s Three Key Takeaways:

  1. Karius Inc’s diagnostic test for lung infections in immunocompromised patients has received FDA Breakthrough Device designation, indicating its potential to improve diagnosis and management in this population.
  2. Clinical data from the PICKUP study demonstrate the test’s effectiveness in increasing the yield for detecting pneumonia and identifying clinically relevant non-pneumonia infections, addressing limitations of current diagnostic approaches.
  3. The test’s rapid, accurate, and sensitive diagnosis of infectious causes of pneumonia offers promise for improving care for patients with hematologic cancers and those undergoing stem cell transplantation, with further insights on cost-effectiveness to be unveiled at a forthcoming medical conference.

Karius Inc announced 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,” says Brad Perkins, MD, chief medical officer of Karius, in a release. “As noted in the American Thoracic Society (ATS) Workshop Report for Immunocompromised Host Pneumonia: Definitions and Diagnostic Criteria, 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

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%. Additionally, the Karius Test identified clinically relevant non-pneumonia infections in 39% of subjects. 

These additional data highlight the ATS Workshop Report observation that “the existing clinical definition of pneumonia is syndromic and lacks specificity,” 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,” says Norman E. Sharpless, MD, former director of the National Cancer Institute and acting commissioner of the FDA, and member of the Karius board, in a release

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.

Photo caption: Karius Test

Photo credit: Karius Inc