Karius Launches Multicenter Study to Evaluate the Diagnostic Value of the Karius Test for Pneumonia in Immunocompromised Patients
August 03, 2020
REDWOOD CITY, Calif., August 3, 2020 – Karius, the world leader in liquid biopsy for infectious diseases, announced today active enrollment in a multicenter, prospective study that will evaluate the diagnostic value of the Karius® Test for pneumonia in immunocompromised adult patients including those with hematological cancers. The Karius Test is a non-invasive blood test based on next-generation sequencing of microbial cell-free DNA that can rapidly detect over 1,000 bacteria, DNA viruses, fungi, and parasites. The test is currently being used by over 100 hospitals nationwide.
The “Pneumonia in the ImmunoCompromised – Use of the Karius Test for the Detection of Undiagnosed Pathogens” (PICKUP) study will compare the diagnostic yield of the Karius Test to standard testing methods used to diagnose infectious causes of pneumonia in immunocompromised patients including those with hematological cancers. Patients with suppressed immune systems are especially vulnerable to life-threatening pneumonias due to their decreased ability to fight infections. Standard methods to diagnose pneumonia can be invasive, time-consuming (requiring weeks to months for a result), and inconclusive, often failing to identify the pathogen causing the infection. The PICKUP study will investigate the additive diagnostic value of the Karius Test in the diagnosis of pneumonia in these patients and its impact on clinical decision-making in this specific population. In addition, the Karius Test will be used to serially monitor pathogen levels during treatment to examine the association between microbial load and pneumonia progression.
“The ability to diagnose invasive life-threatening infections in immunocompromised patients has been one of the most challenging areas in clinical infectious disease practice,” said Karius CEO, Mickey Kertesz. “We are enthusiastic to be collaborating with a number of leading cancer centers for this study and anticipate that the Karius Test will demonstrate a higher diagnostic yield than traditional invasive testing methods.”
“Often in pneumonia, the causative pathogen is unknown or can be challenging to diagnose despite extensive diagnostic testing,” said Dr. Stephen Bergin, Assistant Professor of Pulmonary and Critical Care Medicine at Duke University Health System and lead investigator for the PICKUP study. “Accurate and timely pathogen identification is particularly critical for immunocompromised patients who are susceptible to life-threatening infections from a much broader array of pathogens. We look forward to exploring the potential value of a non-invasive tool capable of rapidly diagnosing respiratory infections in this vulnerable population.”
Previous studies have demonstrated the ability of the Karius Test to overcome many of these limitations to diagnose the cause of pneumonia and enable targeted treatment. The study will include approximately 200 patients from up to 10 centers in the United States.
For more information consult: https://clinicaltrials.gov/ct2/show/NCT04047719
The organizations that are participating in this study include:
- Duke University Health (Lead study site);
- University of Pittsburgh Medical Center;
- Fred Hutchinson Cancer Research Center;
- The University of Texas MD Anderson Cancer Center;
- City of Hope;
- Tulane Cancer Center and Tulane Medical Center; and
- The University of California, San Francisco Medical Center
Karius is a life sciences company focused on generating genomic insights for infectious diseases with the Karius Test, a non-invasive blood test that helps clinicians make rapid, treatment decisions. By mapping each patient’s microbial landscape from a single blood draw, Karius moves closer to a vision of a world where infectious disease is no longer a major threat to human health.