NEW YORK – Infectious disease startup Karius announced on Tuesday that its Karius Test for infectious disease detection has received approval from the New York State Department of Health's Clinical Laboratory Evaluation Program.
The liquid biopsy test, which is intended for use with immunocompromised and recent transplant patients, is approved for use in all five pathogen categories: bacteriology, mycobacteriology, mycology, parasitology, and virology, Karius said in a statement.
The laboratory-developed test is commercially available from a CLIA-certified and CAP-accredited laboratory in Redwood City, California, where the company is based.
It uses microbial cell-free DNA to detect more than 1,400 bacteria, DNA viruses, fungi, and parasites, comparing fragments of DNA to its reference data resource of pathogen genomes and providing clinicians with the genus and species of the organism, in addition to quantitative information about the number of DNA fragments found in the plasma sample. That number can correlate to the severity of the infection.