Clinical Evidence
In partnership with leading institutions, we’re building the evidence base to inform clinical decisions and support better patient outcomes.
Key Publications
Backed by 200+ peer-reviewed studies, Karius’ metagenomic sequencing tests demonstrate strong clinical validity and utility across patient populations, diagnostic applications, and care settings.
SEP-SEQ Study
Metagenomic sequencing was clinically validated in the SEP-SEQ Study, which enrolled 350 patients with suspected sepsis in the Emergency Department at Stanford University Hospital. The study demonstrated high agreement with standard diagnostics, increased pathogen detection compared to blood cultures and other microbiological tests, and potentially faster identification of the etiology of sepsis than the standard diagnostic workup.
PICKUP Study
The PICKUP Study is the first multi-center, prospective observational study designed to evaluate the clinical utility of the Karius Spectrum™ test in adults with hematologic malignancies or hematopoietic cell transplants and suspected pneumonia. The study enrolled 257 patients across ten leading U.S. medical centers and showed a 40% relative increase in the adjudicated cause of pneumonia when Karius Spectrum was added to the standard diagnostic workup.
Real-World Evidence Study
In a retrospective analysis of over 15,000 patients that were commercially tested with the Karius Spectrum™ test, plasma metagenomic sequencing demonstrated rapid turnaround time (median 26 hours), broad pathogen detection including diagnostically challenging organisms, and quantitative results that correlated with single-analyte qPCR. The findings highlight the test’s potential to support clinical decision-making and disease surveillance when paired with expert interpretation and diagnostic stewardship.
Clinical Data
Discover our comprehensive library of over 200 peer-reviewed publications from leading institutions, highlighting the clinical utility of the Karius Spectrum test across diverse patient populations and diagnostic applications. Visit our Clinical Data page to explore the full body of evidence.