Karius

Karius develops clinical metagenomic tests that help clinicians identify pathogens causing serious infections.

Founded

2014

Competitive Advantages

Karius differentiates on agnostic, quantitative detection of a broad pathogen set from a single minimally invasive sample rather than sequential pathogen-specific assays. The plasma test can surface microbial cell-free DNA shed from localized infections without tissue collection from the infected site, reporting within about a day compared with conventional methods that can take days to weeks, with optional genotypic bacterial resistance markers supporting targeted antimicrobial decisions.

The approach is supported by clinical studies including the multicenter PICKUP program in immunocompromised pneumonia, where addition of the test increased relative diagnostic yield, alongside FDA Breakthrough Device designation for lung-infection use and incorporation into endocarditis diagnostic criteria. A curated pathogen database refined on accumulating data, centralized high-complexity laboratory operations, and distribution through collaborators extend availability while preserving rapid turnaround.

Source: kariusdx.com

Market Outlook

Demand for rapid, comprehensive infection diagnostics is supported by rising rates of complicated and hospital-acquired infections in immunocompromised populations, the limits of conventional testing that leave many pneumonias undiagnosed, and pressure to curb broad-spectrum antibiotic use amid antimicrobial resistance. Metagenomic sequencing paired with machine-learning interpretation addresses these gaps by identifying causative pathogens sooner and informing narrower therapy.

Karius is expanding access beyond its hospital base through reference-laboratory distribution, joint education and field training, and continued evidence generation in high-risk cohorts. The company is also extending detection from DNA to RNA under government-supported programs and researching broader applications of microbial cell-free DNA, positioning plasma and respiratory metagenomics as adjuncts to standard workups.