Karius Test® Earns FDA Breakthrough Device Designation for Advancing Infectious Disease Diagnosis

Karius, a leader in genomic diagnostics for infectious diseases, has announced that its Karius Test® received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA).  

This designation covers its use in diagnosing and managing suspected lung infections, including lower respiratory infections and pneumonia, in immunocompromised patients.

The Karius Test is already available nationwide as a laboratory-developed test, and Karius is now seeking FDA marketing authorization specifically for lung infections in immunocompromised patients due to the critical need for improved diagnostic tools in this group. 

Lung infections pose significant risks of morbidity and mortality in immunocompromised individuals, as noted in the American Thoracic Society (ATS) Workshop Report on Immunocompromised Host Pneumonia. Advances in technology, such as the metagenomic sequencing utilized by the Karius Test, are essential for better diagnosing and treating these patients.

The Breakthrough Devices Program is designed to accelerate the development and review process for certain medical devices and device-led combination products that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. This program aims to expedite the development and review of these innovative medical devices.

Supporting the use of the Karius Test in pneumonia among immunocompromised patients, the PICKUP study found that the test improved the relative detection yield of a probable pneumonia cause by 40%. The test identified clinically relevant non-pneumonia infections in 39% of subjects.   

Recent trial data indicate that the Karius Test provides rapid, accurate, and sensitive diagnosis of infectious causes of pneumonia and related infections in immunocompromised patients, representing a significant advancement in the care of patients with hematologic cancers and those undergoing stem cell transplantation.

Source: https://www.businesswire.com/news/home/20240516554967/en/Karius-Test%C2%AE-Receives-FDA-Breakthrough-Device-Designation-to-Aid-in-the-Diagnosis-of-Infectious-Disease