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Transforming infectious disease diagnostics with genomics
SUMMARY OF 1,000+ SAMPLES
Clinical Experience with the Karius Next-Generation Sequencing
Test in 1,000+ Patients
CLIA #: 05D2121236CAP #: 9497749
The Karius Test
SAMPLE PROCESSING METRICSOf the 1,036 samples tested, 54.7% were
from adult patients and 45.3% were from pediatric patients.
The sample acceptance rate in this cohort was 97.6% with a first
pass yield of 88.5% and total result yield of 97.7%.
Results were delivered the next day following sample receipt for
82.5% of patients.
SUMMARY OF THE FIRST 1,000+ KARIUS TESTS
CLINICAL APPLICATIONS OF THE KARIUS TESTThe most common clinical
scenarios (identified by ICD codes and clinical consultation) for
which the samples were submitted included patients who were
immunocompromised, complicated pneumonia, infective endocarditis
(including M. chimaera infections), and sepsis.
Tests for immunocompromised patients were commonly sent in the
setting of fever and neutropenia, following stem-cell transplant,
or when invasive fungal infection was suspected.
Samples for sepsis patients included culture-negative scenarios
where other diagnostics may have had poor sensitivity.
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 pneumonphila, and Mycobacterium tuberculosis
complex) and fungi (such as Histoplasma capsulatum, Coccidiodes
immitis, and Pneumocystis jirovecii).
Infectious diseases remain an important and significant cause of
morbidity and mortality for patients. Many infections, such as
culture- negative and deep-seated infections, can be diagnostically
challenging.
The Karius Test can non-invasively identify more than 1,000
pathogens (including bacteria, fungi, DNA viruses, and eukaryotes)
using next-gener-ation sequencing of cell-free pathogen DNA in
plasma.
The preferred sample type for the Karius Test is 5mL of whole
blood collected in a Plasma Preparation Tube (PPT) that is then
centrifuged and sent to the Karius CAP-accredited, CLIA-certified
laboratory via FedEx overnight service.
• Infectious diseases remain a significant cause of morbidity
and mortality• Many infections are culture-negative or
diagnostically challenging,
precluding early or targeted treatment• Current diagnostics are
limited by sensitivity, specificity, and requirement
for tissue specimens• Next-generation whole-genome sequencing of
cell-free plasma is a non-
invasive testing strategy that enables powerful clinical
insights in diagnostically challenging cases
• The Karius next-generation sequencing (NGS) assay identifies
microbial cell-free DNA (cfDNA) in plasma from bacteria, DNA
viruses, yeasts, mold, and protozoa
• Next day results* are reported from a single blood draw
processed at CAP-accredited and CLIA-licensed laboratory
The Karius® Test
Background RESULTSClinical Experience: First 1000+ commercial
samples
• The Karius® Test is a validated test1 for comprehensive
detection of pathogens via NGS of cell-free DNA from plasma2• NGS
testing can be useful in diagnostically challenging cases where
conventional diagnostics have limited sensitivity• The Karius® Test
has demonstrated utility in identifying causative pathogens in
endocarditis, pneumonia, and sepsis, as well as causes of
infections
in immunocompromised patients3,4
Number of pathogens detected:69% of cases reported 1 or 2
microbes
• Immunocompromised patients• Endocarditis/M. chimaera
infection• Pneumonia (complicated pneumonia) • Sepsis*Based on
interpretation of ICD codes where provided and clinical
consultations; inpatients only
Applications of the Karius ® TestSepsis: where current
diagnostics may have poor sensitivity Including culture-negative
sepsis, endocarditis and pneumoniaInfections in immunocompromised
patients: in the context of fever and neutropenia, stem-cell
transplant and invasive fungal infections where a wide breadth of
pathogens can cause infection
Top use cases* among first 1036 test samples
Notable bacteria reported:- Bartonella henselae- Coxiella
burnetti- Legionella pneumophila- Leptospira kirschneri-
Mycobacterium tuberculosis
Pathogens identified by the Karius® Test
Turn-around Time and Processing Metrics
261 unique pathogens detected by over 1036 tests
Notable fungi reported:- Aspergillus fumigatus- Coccidioides
immitis- Histoplasma capsulatum- Blastomyces dermatiditis-
Pneumocystis jirovecii
REFERENCES1. Blauwkamp TA, Thair S, Rosen MJ, Blair L, Lindner
MS, Vilfan ID et al. "Analytical and Clinical Validation of a
Microbial Cell-Free DNA Sequencing Test for Infectious Disease",
Under Review2. De Vlaminck I, Martin L, Kertesz M, Patel K,
Kowarsky M, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J,
Nicolls MR. Noninvasive monitoring of infection and rejection after
lung transplantation. Proceedings of the National Academy of
Sciences. 2015 Oct 27;112(43):13336-41.3. Hong DK, Blauwkamp TA,
Kertesz M, Bercovici S, Truong C, Banaei N. Liquid biopsy for
infectious diseases: Sequencing of cell-free plasma to detect
pathogen DNA in patients with invasive fungal disease, Diagn
Microbiol Infect Dis 2018; In press.
https://doi.org/10.1016/j.diagmicrobio.2018.06.0094. Abril MK,
Barnett AS, Wegermann K, Fountain E, Strand A, Heyman BM et al.
Diagnosis of Capnocytophaga canimorsus sepsis by whole-genome
next-generation sequencing. Open Forum Infect Dis 2016; 3:1-4.
Fever of Known Origins:Clinical Experience with the Karius®
Next-Generation Sequencing Test in 1000+ Patients
Asim A. Ahmed MD, David K. Hong MD, Sudeb C. Dalai MD, PhD,
Varsha Baichwal MS, Sumedha Sinha PhD, Desiree Hollemon MSN, MPH,
Timothy A. Blauwkamp PhD, Sivan Bercovici PhD, Mickey Kertesz
PhD
Karius, Inc., Redwood City, CAkariusdx.com
Case Highlights
Summary
https://doi.org/10.1016/j.diagmicrobio.2018.06.009
