About
Karius is transforming infectious disease diagnostics by combining clinical metagenomics, artificial intelligence, and next-generation sequencing into CLIA-certified, CAP-accredited laboratory tests. The platform detects microbial cell-free DNA (mcfDNA) circulating in the bloodstream or present in bronchoalveolar lavage fluid, enabling clinicians to identify pathogens behind deep-seated, systemic, or pulmonary infections—even when conventional testing fails. Karius Spectrum™ is a blood-based plasma metagenomic sequencing test that can identify over 1,000 clinically relevant fungi, bacteria, DNA viruses, and parasites from a single sample. It is designed for patients with difficult-to-diagnose systemic infections, including immunocompromised individuals. Karius Focus™ | BAL is a bronchoalveolar lavage fluid-based test targeting over 500 respiratory pathogens associated with pneumonia and other lung infections, with particular utility in immunocompromised patients. Underpinning both tests is a proprietary AI engine featuring advanced machine learning algorithms that analyze complex genomic data in real time, continuously refined by a growing proprietary reference genome database. Karius collaborates with leading institutions such as Mayo Clinic Laboratories to expand access and validate clinical utility. The platform is ideal for infectious disease specialists, hospitalists, pulmonologists, and oncologists managing critically ill or immunocompromised patients.
Key Features
- Microbial Cell-Free DNA (mcfDNA) Detection: Detects microbial DNA circulating in blood or lung fluid to identify active pathogens without requiring invasive tissue samples or pathogen culture.
- Karius Spectrum™ – Broad Systemic Pathogen Detection: A blood-based plasma metagenomic sequencing test capable of identifying over 1,000 fungi, bacteria, DNA viruses, and parasites in a single test run.
- Karius Focus™ | BAL – Targeted Lung Infection Testing: A bronchoalveolar lavage fluid test designed to detect and classify over 500 respiratory pathogens associated with pneumonia and lung infections.
- AI-Powered Genomic Analysis: Proprietary machine learning algorithms analyze complex genomic datasets in real time, with a continuously updated reference genome database for improved accuracy.
- CLIA & CAP Accredited Laboratory: All tests are processed in a laboratory certified under CLIA '88 and accredited by the College of American Pathologists, ensuring high-complexity clinical testing standards.
Use Cases
- Diagnosing difficult-to-identify systemic infections in hospitalized patients when blood cultures and conventional tests are negative
- Identifying pulmonary pathogens in immunocompromised patients (e.g., transplant recipients, cancer patients) with suspected pneumonia
- Rapid broad-spectrum pathogen screening to guide antibiotic or antifungal therapy decisions in the ICU
- Detecting rare or atypical organisms—such as endemic fungi or unusual parasites—that standard labs are not equipped to identify
- Supporting infectious disease research and clinical studies requiring comprehensive pathogen profiling from patient samples
Pros
- Unmatched Pathogen Coverage: A single test can screen for over 1,000 pathogens simultaneously, dramatically reducing the time and number of tests needed compared to conventional methods.
- Valuable for Immunocompromised Patients: Particularly effective for patients who cannot mount a detectable immune response, where conventional cultures and serology often fail.
- AI-Enhanced Real-Time Results: Machine learning-driven analysis accelerates result turnaround and improves detection sensitivity, enabling faster clinical decision-making.
- Clinically Validated & Institutionally Backed: Partnerships with Mayo Clinic Laboratories and peer-reviewed publications lend strong clinical credibility to the platform.
Cons
- Restricted to Clinical Settings: Karius tests require physician ordering and specialized sample collection, making them inaccessible for direct consumer or routine outpatient use.
- High Cost of Testing: As an advanced NGS-based clinical lab test, costs may be significant and insurance coverage can vary, potentially limiting broad adoption.
- Limited to DNA-Based Pathogens: The mcfDNA approach may not reliably detect RNA viruses or pathogens with very low circulating DNA levels, leaving some diagnostic gaps.
Frequently Asked Questions
What is the Karius Spectrum test?
Karius Spectrum™ is a blood-based plasma metagenomic sequencing test that analyzes microbial cell-free DNA to detect over 1,000 pathogens—including bacteria, fungi, DNA viruses, and parasites—from a single blood draw.
What is the Karius Focus | BAL test?
Karius Focus™ | BAL is a metagenomic sequencing test performed on bronchoalveolar lavage (BAL) fluid. It is designed to detect and classify over 500 pathogens associated with pneumonia and other pulmonary infections, especially in immunocompromised patients.
How does microbial cell-free DNA (mcfDNA) testing work?
When a pathogen is active in the body, fragments of its DNA circulate in the bloodstream or body fluids. Karius collects these fragments, sequences them using NGS, and compares them against a proprietary reference genome database using AI to identify what pathogens are present.
Who should use Karius testing?
Karius tests are intended for use by healthcare providers—such as infectious disease specialists, pulmonologists, and oncologists—managing critically ill or immunocompromised patients where conventional diagnostic methods have been inconclusive.
Is Karius laboratory certified for clinical use?
Yes. The Karius laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) and accredited by the College of American Pathologists (CAP) for high-complexity clinical laboratory testing.
