Karius snares FDA breakthrough tag for genomic infectious disease blood test

After picking up $100 million in venture capital cash earlier this month, Karius is adding another feather to its cap with a breakthrough designation from the FDA.

The company’s DNA-based blood test for infectious diseases, designed to detect more than 1,000 pathogens from a single sample, is getting a boost at the agency toward helping manage immunocompromised patients suspected of threatening lung conditions.

The Karius Test has been commercially available since 2017 as a lab-developed test, and the company has said it is currently being employed at about 400 nationwide locations—largely at cancer centers, where patients may have heightened risks of respiratory infections and pneumonia from bacteria, fungi, parasites and viruses.

Karius has estimated that about 60% of deaths among people with cancer can be attributed to infections instead of the malignancy itself.

A future FDA approval or clearance will help the former Fierce 15 winner increase its reach to an even broader range of health systems and patients, according to Karius’ chief medical officer, Brad Perkins, M.D.

“The Karius Test marks the first of its kind metagenomics infectious disease test to receive recognition from the Breakthrough Device Designation program,” Perkins told Fierce Medtech.

“The specific regulatory pathway is something we are very much looking forward to discussing with the agency,” he added. “We'll work with them collaboratively to identify a clear path forward to integrate our technology into routine patient care.”

The company’s clinical study has shown that the Karius blood test was able to identify the probable cause of pneumonia in 12% of patients after all standard efforts had failed. It also found that antimicrobial therapies could have been optimized, with some being steered away from unnecessary uses, in 81% of those cases.

“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,” Karius board member Ned Sharpless, M.D., former director of the National Cancer Institute, said in a statement.