Clinical Data

Rapid, Non-invasive Detection of Infection Using Plasma-based Next-Generation Sequencing for Microbial Cell-free DNA in Individuals Testing Negative for SARS-CoV-2 in a Pandemic Setting

IDWeek 2020 | October 2020

Non-invasive Diagnosis of Whipple Endocarditis Using Next-Generation Sequencing for Microbial Cell-free DNA in Plasma

IDWeek 2020 | October 2020

Rapid, Non-invasive Detection of Invasive Mycoplasma hominis Infection using the Karius Test, A Next-Generation Sequencing Test for Microbial Cell-free DNA in Plasma

IDWeek 2020 | October 2020

Karius Cell-Free DNA Metagenomic Assay of Plasma Detects Pulmonary and Disseminated Trichosporon Infections in Patients with Hematological Malignancies

IDWeek 2020 | October 2020

Microbial Cell-Free DNA Sequencing for Evaluation of Response to Antibiotic Therapy in Patients with Relapsed or Refractory Leukemia

IDWeek 2020 | October 2020

Rapid, Non-invasive Detection of Legionella and Resolution of Species Diversity in Clinical Infections Using a Plasma-based Microbial Cell-free DNA Sequencing Test for Pathogen Identification

ASM Microbe 2020 | June 2020

Microbial Cell-free DNA Sequencing for Multiplexed Detection and Quantitation of Cytomegalovirus, Epstein-Barr Virus, and BK Virus

AMP 2019 | November 2019

Retrospective Case-Control Study of the Performance of the Karius Test, a Plasma Microbial Cell-Free DNA Next-Generation Sequencing Test, to Detect Invasive Mold Infections in Hematopoietic Cell Transplant Recipients with Pneumonia

IDWeek 2019 | October 2019

Next-Generation Sequencing Based Detection of Angiostrongylus cantonensis (AC) Using Microbial Cell-Free DNA Sequencing of Plasma in Atypical Cases of Rat Lungworm Meningitis Presenting with Ascending Paralysis.

IDWeek 2019 | October 2019

Plasma and Respiratory Specimen Metagenomic Sequencing for the Diagnosis of Severe Pneumonia in Mechanically-Ventilated Patients

IDWeek 2019 | October 2019

Detection of Bartonella Species in Culture-Negative Endocarditis Using the Karius Test, a Plasma Next-Generation Sequencing Test for Pathogen Detection

ASM Microbe 2019 | June 2019

Evaluation of the Karius^® Plasma Next Generation Sequencing Cell-free Pathogen DNA Test to Detect and Quantitate Cytomegalovirus, Epstein-Barr Virus, and BK Virus

ASM Microbe 2019 | June 2019

Plasma Microbial Cell-free DNA Sequencing (The Karius® Test) for the Diagnosis and Management of Infective Endocarditis

ISCVID 2019 | June 2019

Pathogen detection in post-mortem samples of children under five in a high HIV prevalence setting using the Karius Test, a quantitative cell-free plasma next-generation sequencing pathogen assay 

ECCMID 2019 | April 2019

Next Generation Sequencing of Microbial Cell-Free DNA for Rapid Noninvasive Diagnosis of Infectious Diseases in Immunocompromised Hosts

TCT 2019 | February 2019

Diagnosis and Genotyping of Coxiella burnetii Causing Endocarditis in a Patient with Prosthetic Pulmonary Valve Replacement Using Next-Generation Sequencing of Plasma

IDWeek 2018 | October 2018

Summary: The Karius Test enabled earlier diagnosis of Coxiella burnettii culture-negative endocarditis (Q Fever) leading to early targeted antimicrobial therapy.

Diagnosis of BCG Aortitis Aided by Plasma Metagenomic Sequencing

IDWeek 2018 | October 2018

Summary: The use of the Karius Test allowed for non-invasive diagnosis of BCG-associated endovascular infection in a patient much faster than AFB cultures and PCR.

Evaluation of the Karius Plasma Next Generation Sequencing Cell-free Pathogen DNA Test to Determine the Etiology of Infection and Impact on Anti-Microbial Management in Patients with Severe Neutropenia and Fever

IDWeek 2018 | October 2018

Summary: The Karius Test can provide fast and accurate detection of pathogens and clinically relevant polymicrobial infections in febrile neutropenic patients which can inform treatment decisions.

Prediction of Bloodstream Infection Prior to Onset of Symptoms by Plasma Metagenomic Sequencing in Pediatric Patients with Relapsed or Refractory Malignancy (PREDSEQ)

IDWeek 2018 | October 2018

Summary: The Karius Test identified bloodstream infections prior to the onset of clinical symptoms in high-risk pediatric cancer patients.

Evaluation of the Karius Plasma Next-Generation Sequencing Test for Pathogen Detection in Pediatric Patients At Risk for Invasive Fungal Infection

ASM Microbe 2018 | June 2018

Summary: We demonstrate the first successful use of cell-free plasma NGS to non-invasively detect invasive fungal infections in immunocompromised pediatric patients.

Direct Detection and Quantification of Bacterial cell-free DNA in Patients with Bloodstream Infection (BSI) Using the Karius Plasma Next-Generation Sequencing (NGS) Test

IDWeek 2017 | October 2017

Summary: This prospective study of 75 patients demonstrated the utility of the Karius plasma NGS test for direct detection of pathogens in patients with BSI. Pathogen cfDNA signal in plasma remains positive longer than blood culture and combined with quantification, could be a useful means for diagnosing and monitoring infections, particularly in those with sterile blood cultures.

The DISCOVER Trial: Application of the Karius Plasma Next-Generation Sequencing Test for Pathogen Detection in Stem-Cell Transplant Patients

IDWeek 2017 | October 2017

Summary: This prospective study of 20 stem-cell transplant (SCT) patients showed that the Karius NGS plasma test had 100% concordance with CMV qPCR above the lower level of quantitation. Using NGS to monitor SCT patients for infection could permit earlier detection of pathogens including CMV, enabling earlier targeted therapy for this high-risk population.

The SEP-SEQ Trial - A Pilot Study Characterizing the Performance of a Novel Plasma Next-Generation Sequencing Assay to Detect Cell-Free Microbial DNA in Patients with Sepsis

ASM Microbe 2017 | June 2017

Summary: This prospective, observational pilot study evaluated the performance of a novel NGS plasma pathogen detection assay in patients presenting to the emergency department with sepsis.

Liquid Biopsy for Infectious Diseases: Application of a Next-Generation Sequencing Cell-Free Plasma Assay to Detect Invasive Fungal Infections

ASM Microbe 2017 | June 2017

Summary: The Karius NGS plasma-based assay is capable of non-invasive detection of cell-free pathogen DNA originating from deep infections. Fungi detected by our open-ended assay included Aspergillus and zygomycetes. This study demonstrates the utility of a non-invasive plasma assay in identifying a causal pathogen in cases of deep fungal infections, which is of particular interest in immunocompromised patients.

Performance of a Novel Plasma-Based Next-Generation Sequencing Assay in Patients with Bacteremia

IDWeek 2016 | October 2016

Summary: We demonstrate high concordance between a novel plasma NGS assay and blood culture in patients with and without bacteremia. In addition, the assay was able to identify pathogens in plasma corresponding to pathogens identified from culture of other body sites. These results highlight the increased sensitivity and versatility of this assay as an alternative diagnostic test in bacteremia, culture-negative, or diagnostically challenging infections.

Diagnosis of Culture-Negative Infections Using a Novel Plasma-Based Next-Generation Sequencing Assay

ASM Microbe 2016 | June 2016

Summary: We report two patients in whom the etiologic diagnosis for febrile illness was confirmed with the Karius Test. The first patient had an implantable cardiac defibrillator infection. Initial blood cultures were negative but culture of the explanted device yielded S. aureus, which was identified by NGS from a plasma specimen obtained prior to device removal. The second patient had extensive cutaneous disease, which on biopsy was thought to be consistent with leprosy. NGS of plasma, however, revealed high levels of Epstein-Barr virus, which was confirmed by quantitative PCR.