Clinical Data

Advanced Quality Control System for Clinical Metagenomic Sequencing Assays

AMP 2019 | November 2019

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

IDWeek 2019 | October 2019

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

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

ASM Microbe 2019 | June 2019

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

ASM Microbe 2019 | June 2019

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

ASM Microbe 2019 | June 2019

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

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

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

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.

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.

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.

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).

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.

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.

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.

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).

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.

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.