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:
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.
Biopsy for Infectious Diseases: Application of a Next-Generation
Sequencing Cell-Free Plasma Assay to Detect Invasive Fungal Infections:
presented by David Hong, M.D., medical director, Karius,
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.
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.
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
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.