Karius’ NGS test for infections shows high sensitivity in pilot study


Results of a pilot study announced Wednesday showed that a next-generation sequencing test for detecting infections showed a high degree of sensitivity in children with leukemia.

Redwood City, California-based Karius worked with the St. Jude Children’s Research Hospital in Memphis, Tennessee to conduct the pilot study, PREDSEQ, in 31 pediatric relapsed and refractory leukemia patients. In total, 11 bloodstream infections occurred in nine participants. Results of the study showed a 78 percent predictive sensitivity in the two days before the onset of infection and an 82 percent diagnostic sensitivity on the day of infection.

While NGS is better known for its use in oncology, Karius is developing the method for detecting bloodstream infections, and its Karius Test is currently able to detect more than 1,000 disease-causing pathogens, including protozoans, bacteria, fungi, nematodes and viruses, by looking for cell-free microbial DNA in patients’ plasma.

The current paradigm for infectious diseases is based on guesswork, which can limit the ability to treat them, CEO Mickey Kertesz said in a phone interview. “Lacking any specific information related to cause of infection, clinicians go for broad spectrum treatment, with own disadvantages,” he said. One way to think about an approach like Karius’s is as a “liquid biopsy” for infections.

Last August, the company raised $50 million in a Series A financing round co-led by Data Collective and Lightspeed Venture Partners. In a phone interview last month, CEO Mickey Kertesz said that its clients include about 50 healthcare systems across the country, though he declined to disclose which ones they were. However, ClinicalTrials.gov lists seven active or completed trials that the company is taking part in, with sites including Stanford University, Lurie Children’s Hospital – affiliated with the Northwestern University Feinberg School of Medicine – Duke University and Tribhuvan University in Nepal.

Karius’ competitors include the lab of Dr. Charles Chiu at the University of California San Francisco, as well as San Francisco-based IDbyDNA, Kertesz said. However, he said their focus is narrower, being placed on brain and respiratory infections, respectively.

Photo: spawns, Getty Images

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