Karius Test Demonstrates Ability to Detect Pathogens from Cell-Free DNA Using Next-Generation Sequencing
New Data Showing Clinical Performance of First Commercially Available Microbial Cell-Free DNA Test Presented at ASM Microbe 2017
June 05, 2017
REDWOOD CITY, Calif. & NEW ORLEANS–(BUSINESS WIRE)–Karius, Inc., a life sciences company focused on conquering infectious
diseases, today announced new data from four studies presented at the
American Society for Microbiology’s Microbe 2017 conference in New
Orleans. Results demonstrate the broad pathogen detection capability of
the Karius Digital Culture™ test, and highlight its promise as an
advanced tool to aid in the rapid diagnosis of difficult-to-detect
infections, the monitoring of infections in high-risk patients, and in
reducing the need for invasive biopsies.
The Karius test uses next-generation sequencing to enable the broad and
rapid detection of more than 1,250 pathogens. Using a standard blood
draw, the Karius test identifies cell-free DNA fragments left by
bacteria, viruses, fungi, and other eukaryotic pathogens in a patient’s
bloodstream, even when living organisms are no longer detectable in the
blood. Karius is the first company to put microbial cell-free DNA
analysis tools into the hands of clinicians, making it commercially
available through its CAP-accredited and CLIA-certified laboratory
service.
“These four studies confirm the potential of the Karius technology
platform to identify pathogens directly from cell-free DNA,” said Mickey
Kertesz, Ph.D., chief executive officer, Karius, Inc. “We believe that
the Karius test will help clinicians reduce the overall time to
diagnosis, spare patients the pain and risks of invasive biopsies, and
lead to more precise and targeted treatment. We are working closely with
select healthcare systems and hospitals to integrate the Karius test
into clinical practice, and we look forward to bringing the test to
additional institutions through our expanded commercial launch in the
coming months.”
“Infectious diseases are a leading cause of death around the world, and
our current methods of testing can only detect a narrow range of
pathogens and may require invasive biopsies,” said Peter Chin-Hong,
M.D., professor and infectious disease specialist at the University of
California, San Francisco, and author of one of the studies. “In our
study of stem-cell transplant patients, this next-generation sequencing
approach showed a high correlation in the detection of cytomegalovirus
compared to standard methods, and also identified other underlying
infections earlier than traditional methods. This ability to identify
pathogens broadly and quickly, and monitor infection in high-risk
patients, holds the potential to allow doctors to develop precise and
effective treatment plans for patients.”
The studies presented at ASM Microbe 2017 demonstrate the potential of
the Karius test as a broad and rapid method for clinical diagnosis of
infectious disease:
- The
DISCOVER Trial: Application of a Novel Plasma Next-Generation
Sequencing Assay to Detect Cell-Free Microbial DNA in Stem-Cell
Transplant Patients: presented by Monica
Fung, M.D., University of California, San Francisco (UCSF) Patients
undergoing stem-cell transplantation are highly susceptible to
infections. The diagnosis of infections can be challenging in this
population, and frequent monitoring is often required for effective
patient care. This pilot study involved 10 stem-cell transplant
patients over the course of three months. The patients had blood drawn
at regular intervals after a stem-cell transplant was performed, and
these samples were then tested using the Karius test to monitor for
infections and help in the diagnosis of infections during fever
episodes. Results from the Karius test were then compared
to the results obtained by conventional tests. When compared to a
conventional cytomegalovirus test, the Karius test showed significant
correlation in detection of this virus. The Karius test was also able
to detect Staphylococcus aureus prior to blood culture and Chlamydia
trachomatis a full 30 days prior to diagnosis by a targeted assay. This
pilot study demonstrates the potential of the Karius test in
monitoring stem-cell transplants for the broad range of pathogens
known to infect these patients. - Liquid
Biopsy for Infectious Diseases: Application of a Next-Generation
Sequencing Cell-Free Plasma Assay to Detect Invasive Fungal Infections:
presented byDavid Hong, M.D., medical director, Karius,
Inc. This study included nine patients who were confirmed
to have deep fungal infections in the brain, heart, lung, and bone, as
diagnosed by a traditional invasive biopsy procedure. A small blood
sample was collected around the time of the initial biopsy and the
Karius test was performed. Results from the Karius test
were then compared to the clinical results from the invasive tissue
biopsy. Of the nine patients studied, the Karius test correctly
identified six invasive fungal infections without the need for
invasive biopsy. This included fungi such as Aspergillus and Rhizopus
that are often difficult-to-diagnose using traditional diagnostic
methods. This study provides initial evidence that
demonstrates the ability of the Karius test to replace invasive
biopsies with a standard blood draw, by using next-generation
sequencing to detect fungal DNA in the blood of patients with deep
infections. - 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: presented
by Simone Thair, Ph.D., Stanford University Medical Center Sepsis
is a leading cause of death and can be caused by a wide range of
potential pathogens. In over 40 percent of cases, a causative pathogen
is never identified. In this study, blood samples were taken from
patients presenting in the emergency department with sepsis and the
Karius test was performed. Results of the test were then compared to
initial blood cultures and subsequent microbial tests. In
this pilot study of 100 patients, the Karius test showed a high
correlation with standard microbiology methods (31 of 38 cases), and
in an additional 16 patients, the Karius test was the only test to
identify pathogens consistent with the clinical scenario. - Detection
of Nocardia cyriacigeorgica from a Deep Pulmonary Infection Using a
Novel Plasma-Based Next Generation Sequencing Assay: presented
by Monica Nayakwadi-Singer, M.D.,UCSF Benioff Children’s
Hospital Oakland This case report involved a seven-year old
female patient with a deep lung infection, as confirmed by a
percutaneous biopsy. Despite a diagnosis of Nocardia cyriacigeorgica
by culture and subsequent treatment, the patient worsened. The Karius
test was ordered to confirm the initial diagnosis and avoid a second
invasive lung biopsy. Within 48 hours of blood collection, the Karius
test confirmed the Nocardia cyriacigeorgica diagnosis and did
not detect other infections. The patient was treated accordingly and
clinically improved. This is the first reported detection
of an invasive Nocardia infection with a plasma
next-generation sequencing assay, which in this case, resulted in
avoiding an invasive diagnostic test.
About the Karius Digital Culture™ Test
The Karius Digital Culture™ test applies advanced sequencing and
analytics for the broad and rapid detection of microbial cell-free DNA
through a standard blood draw. Unlike conventional culture and panel
testing methods that test for a narrow range of pathogens, the Karius
test can detect more than 1,250 pathogens. Through Karius’
CAP-accredited and CLIA-certified laboratory service, the test empowers
doctors to diagnose infections, provide more targeted treatment, and
spare patients the pain and risks of invasive biopsies.
About Karius, Inc.
Karius is a life sciences company focused on conquering infectious
diseases through the innovative use of next-generation sequencing to
analyze microbial cell-free DNA. The company’s genomics platform
delivers unprecedented insight into the microbial landscape, providing
clinicians with a comprehensive test capable of identifying more than a
thousand pathogens directly from blood and helping industry accelerate
drug development. For more information visit kariusdx.com
and follow us on Twitter at @kariusdx.
Contacts
Karius, Inc.
Krysta Pellegrino, 650-255-6142
media@kariusdx.com
Jessica
Volchok, 310-849-7985
media@kariusdx.com
