Karius, Inc., a life sciences company transforming infectious disease diagnostics with genomics, announced today the results of an ongoing clinical study of adult patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
REDWOOD CITY, Calif. — Dec 13, 2018 — Karius, Inc., a life sciences company transforming infectious disease diagnostics with genomics, announced today the results of an ongoing clinical study of adult patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). The early findings showed that the Karius® Test, a non-invasive blood test that detects pathogen cell-free DNA in plasma, is an effective infectious disease diagnostic that can quickly and accurately detect infections early and potentially help guide therapy in these patients.
Allo-HSCT is a life-saving treatment for patients with high-risk leukemia. However, it increases the risk of infections, which can cause significant complications and death in this population [1]. Diagnosing infections in allo-HSCT patients is challenging due to their susceptibility to uncommon pathogens and atypical clinical presentations of disease. Current laboratory methods are also frequently unable to establish a clear diagnosis for an infection. [1,2]
Dr. Monica Fung, UCSF, first author of the study, says “We often struggle to make a diagnosis in patients with stem cell transplants. Their infections don’t manifest with the typical symptoms you see in healthy individuals. What is exciting about the Karius Test is its ability to test a really broad range of pathogens quickly.”
The publication describes three unique cases that highlight the benefits of a novel, non-invasive, rapid diagnostic tool for the management of patients at high risk of infections. These patients are enrolled in the DISCOVER (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time) study at UCSF. In these patients, the Karius Test had the potential to detect bacterial infections prior to initial symptoms or conventional tests.
Dr. Peter Chin-Hong and Dr. Aaron Logan from UCSF were lead authors of the study. Dr. Chin-Hong says: “The timing of a diagnosis for an infection in immunocompromised patients is very important, every minute matters. These findings show the utility of the test to quickly and accurately detect infections with a non-invasive method.”
One case showed that the Karius Test detected Chlamydia trachomatis 7 days prior to initial symptoms and 30 days prior to standard microbiologic diagnosis. In another case, the Karius Test detected Staphylococcus aureus even after the patient had been on antibiotics and before conventional microbiology tests identified an infection. These findings suggest the potential value of the Karius Test to help guide therapy and monitor treatment to help improve outcomes.
“This first look at the results from the DISCOVER trial shows the promise of the Karius Test in identifying pathogens in stem-cell transplant patients prior to conventional microbiology tests. This could lead to earlier targeted treatment in these high-risk patients,” says Dr. David Hong, VP of Medical Affairs and Clinical Development at Karius.
The study is available on the Open Forum Infectious Diseases Journal’s website at https://academic.oup.com/ofid/
- Wingard JR, Hsu J, Hiemenz JW. Hematopoietic Stem Cell Transplantation: An Overview of infection risks and epidemiology.
- Serody JS, Berrey MM, Albritton K, et al. Utility of obtaining blood cultures in febrile neutropenic patients undergoing bone marrow transplantation. Bone Marrow Transplant, 2000; 26: 533-8.
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About Karius, Inc.
Karius is a life sciences company focused on transforming infectious disease diagnostics with genomics and data through the innovative use of next-generation sequencing to analyze microbial cell-free DNA. The Karius laboratory is CLIA-certified and CAP-accredited to perform high-complexity clinical laboratory testing. The company’s genomics platform and clinically-curated pathogen database deliver deep insight into the microbial landscape, providing clinicians with a comprehensive, quantitative 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.
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