Clinical Data | Karius

Clinical Data

Publications

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Rossoff et al.

Non-invasive diagnosis of infection using plasma next-generation sequencing: A single center experience

Open Forum Infectious Diseases 2019 August, 6(8): ofz327. doi: 10.1093/ofid/ofz327.

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Blauwkamp et al.

Analytical and clinical validation of a microbial cell-free DNA sequencing test for infectious disease

Nature Microbiology 2019 April, 4(4):663-674. doi: 10.1038/s41564-018-0349-6.

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Farnaes et al.

Community acquired pneumonia in children: Cell free plasma sequencing for diagnosis and management

Diagnostic Microbiology and Infectious Disease 2019 June, 94(2):188-191. doi:  10.1016/j.diagmicrobio.2018.12.016.

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Armstrong et al.

Cell-free DNA next-generation sequencing successfully detects infectious pathogens in pediatric oncology and hematopoietic stem cell transplant patients at risk for invasive fungal disease

Pediatric Blood & Cancer 2019 July, 66(7). doi: 10.1002/pbc.27734. 

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Kondo et al. 

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

Open Forum Infectious Diseases 2019 June, 6(6): ofz242. doi: 10.1093/ofid/ofz242.

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Vudatha et al.

Rapid detection of bacille Calmette-Guérin-associated mycotic aortic aneurysm using novel cell-free DNA assay

Journal of Vascular Surgery Cases and Innovative Techniques 2019 June, 5(2):143-148. doi: 10.1016/j.jvscit.2018.11.006.

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Nomura et al.

Rapid detection of invasive Mycobacterium chimaera disease via a novel plasma-based next-generation sequencing test

BMC Infectious Diseases 2019 May, 19:371. doi: 10.1186/s12879-019-4001-8.

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Zhou et al.

Utility of Whole-Genome Next-Generation Sequencing of Plasma in Identifying Opportunistic Infections in HIV/AIDS

The Open AIDS Journal, 2019 February, Volume 13. doi: 10.2174/1874613601913010007.

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Fung et al.

Plasma Cell-free DNA Next-generation Sequencing to Diagnose and Monitor Infections in Allogeneic Hematopoietic Stem Cell Transplant Patients

Open Forum Infectious Diseases 2018 November, ofy301. doi: 10.1093/ofid/ofy301.

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Hong et al.

Liquid biopsy for infectious diseases: Sequencing of cell-free plasma to detect pathogen DNA in patients with invasive fungal disease

Diagnostic Microbiology and Infectious Disease 2018 November, 92 (3): 210-213. doi: 10.1016/j.diagmicrobio.2018.06.009.

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Abril et al.

Diagnosis of Capnocytophaga canimorsus Sepsis by Whole-Genome Next-Generation Sequencing

Open Forum Infectious Diseases 2016 Sep, 3(3):ofw144. doi: 10.1093/ofid/ofw144.

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De Vlaminck et al.

Noninvasive monitoring of infection and rejection after lung transplantation

PNAS 2015 October, 112(43):13336-13341. doi: 10.1073/pnas.1517494112.

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Abstracts

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

AMP 2019 | November 2019

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Advanced Quality Control System for Clinical Metagenomic Sequencing Assays

AMP 2019 | November 2019

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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

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Rickettsia typhi Detection in Clinical Infections by the Karius Test, a Plasma Microbial Cell-free DNA Next-Generation Sequencing Test

IDWeek 2019 | October 2019

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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

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Integrating Diagnostics of Tomorrow into Clinical Practice Today: One Infectious Disease Group’s 1st 90 Days Experience With the Karius® Test

IDWeek 2019 | October 2019

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

IDWeek 2019 | October 2019

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Improving the clinical specificity of the unbiased Karius test via literature mining

ASM Microbe 2019 | June 2019

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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

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Sequencing of Plasma Cell-Free DNA for Pathogen Detection in Prosthetic Joint Infections

ASM Microbe 2019 | June 2019

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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

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Next-generation Sequencing of Pathogen Cell-free DNA in Plasma (Karius Test) Reveals Nocardia Species Diversity in Clinical Infections

ASM Microbe 2019 | June 2019

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

ISCVID 2019 | June 2019

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Detection and quantification of Plasmodium falciparum and Plasmodium vivax in a human challenge model using the Karius test, a cell-free DNA sequencing pathogen assay 

ECCMID 2019 | April 2019

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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

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Retrospective Case-Control Study of the Performance of Cell-Free Plasma Sequencing to Detect Invasive Mold Infections in Hematopoietic Cell Transplant Recipients with Pneumonia

TCT 2019 | February 2019

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

TCT 2019 | February 2019

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Use of the Quantitative Karius®Plasma Next Generation Sequencing Cell-Free Pathogen DNA Test to Detect and Monitor Cytomegalovirus Infection in Allogeneic Stem-Cell Transplant Recipients

TCT 2019 | February 2019

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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.

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Direct Detection and Quantification of Bacterial Cell-free DNA in Patients with Infective Endocarditis Using the Karius Plasma Next Generation Sequencing Test

IDWeek 2018 | October 2018

Summary: The Karius Test, with its ability to detect and quantitate a wide breadth of pathogens, can be a useful diagnostic and monitoring tool for infective endocarditis, even in patients with culture-negative endocarditis.

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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.

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Plasma Next-Generation Sequencing for Pathogen Detection in Pediatric Patients at Risk for Invasive Fungal Infection

IDWeek 2018 | October 2018

Summary: The Karius Test can detect invasive fungal infections (IFI) directly from blood in high-risk pediatric immunocompromised patients and can identify non-fungal pathogens in individuals that have prolonged febrile neutropenia but do not meet criteria for proven or probably IFI.

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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.

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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.

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Streptococcus pneumoniae-related hemolytic uremic syndrome (pHUS) and the identification of matched cross-country serotypes by plasma next-generation sequencing (NGS)

IDWeek 2018 | October 2018

Summary: The Karius Test can detect culture-negative infections and has the potential to identify clusters of disease.

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Clinical Experience with the Karius Next-Generation Sequencing Test in 1,000+ Patients 

AGBT 2018 | September 2018

Summary: The Karius Test demonstrated clinical utility by identifying challenging infections in the patients tested. There were 261 unique pathogens identified in the 1,036 samples tested. A total of 554 patients had 1 microbe reported with 69% of these having 1 or 2 microbes reported. Test results included notable bacteria (such as Bartonella henselae, Legionella pneumophila, and Mycobacterium tuberculosis complex) and fungi (such as Histoplasma capsulatum, Coccidiodes immitis, and Pneumocystis jirovecii).

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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.

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Detection of Pathogen Cell-Free DNA in Maternal Plasma in Patients with Chorioamnionitis Using a Non-Invasive Next-Generation Sequencing Assay

SRI 2018 | March 2018

Summary: Subclinical intra-amniotic infection (IAI) has been linked to spontaneous preterm labor and complications such as neonatal sepsis. The Karius Test was used to show the detection of relevant pathogen cfDNA in maternal plasma during IAI for the first time. Next-generation sequencing may lead to the development of a specific assay to detect perinatal infections for targeted therapy: a non-invasive method to detect fetal exposure to pathogens.

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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.

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Performance of the Karius Plasma Next-Generation Sequencing Test in Determining the Etiologic Diagnosis of Febrile Neutropenia: Results from a Pilot Study

IDWeek 2017 | October 2017

Summary: This study enrolled 32 patients with neutropenic fever (NF) to compare the performance of the Karius plasma test to blood cultures, which often are unable to identify a pathogen in patients with NF. The Karius® Test detected all organisms found by blood culture, identified polymicrobial infections not detected by standard microbiologic testing, and identified a probable cause of NF more often than blood culture alone.

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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.

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Rapid Detection of Invasive Mycobacterium chimaera Infection by Using a Novel Plasma-Based Next-Generation Sequencing Assay

IDWeek 2017 | October 2017

Summary: This is the first reported detection of Mycobacterium chimaera (Mc), a member of the M. avium complex (MAC), using a plasma-based NGS assay. The Karius M. chimaera assay identified Mc approximately 15 days sooner than AFB culture positivity and 36 days sooner than speciation from AFB culture. Given widespread exposure to contaminated heater-cooler devices and the high case-fatality rate after infection, an urgent need exists for rapid, sensitive, noninvasive assays to detect Mc.

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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.

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Detection of Nocardia cyriacigeorgica from a Deep Pulmonary Infection Using a Novel Plasma-Based Next-Generation Sequencing Assay

ASM Microbe 2017 | June 2017

Summary: The diagnosis of deep life-threatening infections often requires invasive sampling of infected tissue for microbiologic diagnosis. However, such procedures are often avoided because of the risk of complications. We describe identification of Nocardia cyriacigeorgica causing a deep lung infection using a novel plasma-based next-generation sequencing (NGS) assay in a patient with chronic granulomatous disease (CGD).

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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.

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Detection of Pathogen DNA using a Novel Plasma-Based Next-Generation Sequencing Assay in Patients with Acute Respiratory Infection

IDWeek 2016 | October 2016

Summary: Determining the etiology of lower respiratory tract infection is challenging. Blood cultures are positive in only 5-14% of patients with pneumonia and it can be difficult to distinguish colonization from infection among organisms identified in sputum or endotracheal cultures. The Karius Test was able to detect both bacterial and viral causes of respiratory infection and may be useful in identifying the etiology of acute respiratory tract infections directly from blood.

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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.

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Diagnosis of Mycobacterium tuberculosis and Non-tuberculous Mycobacterium Infections Using a Novel Plasma-Based Next-Generation Sequencing Assay

ASM Microbe 2016 | June 2016

Summary: Mycobacterial infections can be difficult to diagnose by conventional culturing methods. This is the first demonstration of the use of a new NGS-based plasma assay to diagnose invasive mycobacterial disease. The high sensitivity and open-ended nature of this NGS assay are advantages that can aid in the diagnosis of deep infections with other fastidious organisms.

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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.

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Diagnosis of Capnocytophaga canimorsus Sepsis by a Novel Cell-free DNA Sequencing Assay

ASM Microbe 2016 | June 2016

Summary: We report the first use of an open-ended cell-free DNA NGS assay to identify the causal pathogen in a patient with sepsis within a clinically actionable timeframe. This technology has the potential to improve targeted therapy for patients with sepsis of unclear etiology.

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Case Reports

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Sepsis Case Reports

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Secondary Infections After Influenza

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Legionella pneumophila in a Renal Transplant Patient

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Invasive Fungal Infections in Immunocompromised Patients

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Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens (PICKUP)

Collaborator: Duke Clinical Research Institute | NCT04047719 

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Next Generation Pathogen Sequencing for Prediction of Adverse Events

Collaborator: St. Jude Children's Research Hospital | NCT03226158

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Detection of Dengue Virus in Plasma of Patients in Nepal

Collaborator: Tribhuvan University | NCT03620487

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Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections

Collaborator: Indiana University | NCT03846804

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Use of NGS Cell-free Pathogen Test for Identification of Low Risk Fever & Neutropenia in Pediatric Patients

Collaborator: Lucille Packard Children's Hospital | NCT03530072

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PREDSEQ Trial. Prediction of Adverse Events in Children and Adolescents With Cancer at High Risk of Infection

Collaborator: St. Jude Children's Research Hospital | NCT03226158

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Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients

Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago | NCT03262584

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Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay

Collaborator: Duke University | NCT02988414

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Determining the Etiology of Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Collaborator: Stanford University | NCT02912117

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DISCOVER Trial. Diagnosis of Infection in Stem Cell Transplant Patients OVER Time

Collaborator: University of California, San Francisco | NCT02804464

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SEP-SEQ Trial. Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay

Collaborator: Stanford University | NCT02730468

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