Karius Gains $100M and FDA Breakthrough Designation for Genomic Pneumonia Test

Karius Inc., a leading company in genomic diagnostics for infectious diseases, announced that its Karius Test has received the FDA's Breakthrough Device designation. This designation aims to facilitate the development and expedited review of the Karius Test, which is designed to diagnose pneumonia and other lung infections in immunocompromised patients.

The Karius Test is a blood-based genomic diagnostic tool that identifies over 1,000 pathogens from a single blood draw. This test is particularly significant for immunocompromised patients, such as those with hematologic cancers or undergoing stem cell transplantation, who are at high risk for severe infections. According to the American Thoracic Society's Workshop Report, these patients have a high morbidity and mortality rate from lung infections, highlighting the urgent need for improved diagnostic methods.

The FDA's Breakthrough Devices Program aims to expedite the development and review of medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The designation of the Karius Test under this program underscores its potential to significantly impact patient care by providing timely and accurate diagnoses.

Clinical data supporting the use of the Karius Test for pneumonia in immunocompromised patients includes the results of the PICKUP study. This study demonstrated that the Karius Test increased the detection of probable pneumonia causes by 40% and identified clinically relevant non-pneumonia infections in 39% of subjects. These findings support the test's utility in improving diagnostic accuracy and patient outcomes.

Karius Inc. utilizes metagenomics, next-generation sequencing, and artificial intelligence to advance the precision and speed of pathogen diagnosis. The Karius Test, performed in a CLIA-certified and CAP-accredited laboratory, is used in over 400 healthcare institutions across the United States, typically delivering results within a day of sample receipt. A study published in the Journal of Clinical Microbiology highlighted the test's capability by detecting 701 unique microbial taxa across 15,000 patients.

See also: Arguably, the World's First Real-time Pathogen Detection Device

The recent $100 million funding round for Karius will support the increased demand for the Karius Test and expand its accessibility to more healthcare providers. The company will present new data on the cost-effectiveness of the Karius Test at the American Thoracic Society Annual Meeting 2024 International Conference.

Topics: HealthTech