Infectious diseases are the second leading cause of death worldwide, accounting for roughly 20% of all human deaths each year. Traditional diagnostics only detect a narrow range of pathogens and can require invasive biopsies. In response to this, Karius was founded in 2014 to improve patient outcomes by transforming infectious disease diagnosis through precision genomics.

The technology behind Karius was developed at the Quake Lab at Stanford University, by Dr Mickey Kertesz and colleagues, and refined for widespread use following a heartbreaking experience trying to help a young transplant patient battling an undiagnosed infection.

Karius has developed a next-generation sequencing test for microbial cell-free DNA that provides clinicians with a comprehensive test capable of identifying more than 1,250 pathogens directly from blood. Unlike conventional culture and panel testing methods that identify a narrow range of pathogens, the Karius test detects microbial cell-free DNA from a broad range of bacteria, fungi, DNA viruses, and eukaryotes (including protozoa) from one blood sample.

The Karius test has been commercially available since early last year and is now expanding to institutions nationwide. Karius has helped clinicians:

  • Accurately detect pathogens in diagnostically challenging or culture-negative infections, including sepsis, endocarditis, fever of unknown origin, and patients who have received antibiotic pre-treatment
  • Quickly identify deep-seated infections such as invasive fungal infections that might otherwise require invasive biopsies
  • Actively monitor immunocompromised patients susceptible to a broad range of pathogens, including stem-cell transplant recipients
  • Precisely target antimicrobial therapy in cases where blood cultures are negative, including febrile neutropenia and infections with fastidious organisms

 

Karius has several clinical trials and collaborations in progress and has presented data regarding the use of the Karius test across several applications:

  • Diagnosis of Bacteremia/Septicemia View Clinical Trial

  • SEP-SEQ Trial. Determining the Etiology of Sepsis View Clinical Trial
  • DISCOVER Trial. Diagnosis of Infection in Stem Cell Transplant Patients OVER Time View Clinical Trial
  • Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay View Clinical Trial
  • Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients View Clinical Trial

 

More information regarding Karius clinical data can be found at https://www.kariusdx.com/publications

The company also offers pathogen biomarker detection as a lab service to biopharma companies who use the Karius test to help accelerate their clinical trials.