Blood test for lung infections granted breakthrough device designation
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Key takeaways:
- The manufacturer of the Karius Test is seeking to market it for diagnosing lung infections in immunocompromised patients.
- The test successfully identified clinically relevant non-pneumonia infections in 39% of patients.
The FDA has granted breakthrough device designation for a blood test to aid in diagnosing pneumonia and suspected lung infections in immunocompromised patients, according to a press release from the manufacturer.
Previously, the Karius Test — which is a non-invasive blood test — was shown to detect pathogens including more than 1,000 clinically relevant bacteria, DNA viruses, fungi and parasites, and identify them quicker than conventional tests.
One 2019 study demonstrated that the test had a sensitivity of 93.7% (95% CI, 84.5-98.2) compared with blood culture and a sensitivity of 92.9% (95% CI, 88.1-96.1) compared with a composite reference standard.
“The Karius Test is commercially available nationwide as a laboratory developed test,” Brad Perkins, MD, chief medical officer of Karius, said in a press release. “We are seeking FDA marketing authorization of the Karius Test for lung infections in immunocompromised patients because improved diagnostic tests are urgently needed for these patients.”
He added that lung infections have high morbidity and mortality in immunocompromised patients, making technologies like metagenomic sequencing — which is used for the Karius Test — vital for diagnosing and treating these patients.
The designation comes after data from the PICKUP study, a multicenter, prospective, observational study, showed that adding the Karius Test to the diagnostic workup for identifying pneumonia causative pathogens improved diagnostic yield over the standard of care alone.
The study assessed 257 adult patients across 10 U.S. medical centers, including Duke University Health, the University of California, San Francisco, Medical Center and Weill Cornell Medicine, comparing the Karius Test with standard of care testing for identifying pneumonia in patients with hematologic malignancies or those who have undergone hematopoietic cell transplantation.
Overall, PICKUP data showed that the Karius Test increased the relative yield for detection of a probable cause for pneumonia by 40% and was able to successfully identify clinically relevant non-pneumonia infections in 39% of patients.
Karius said that additional data from PICKUP on the cost-effectiveness of the Karius Test will be presented at a conference later this year.
References:
- Karius. PICKUP: Pneumonia in the ImmunoCompromised: Use of the Karius Test for the Detection of Undiagnosed Pathogens. https://kariusdx.com/pickup-study. Accessed May 16, 2025.
- Karius Test receives FDA breakthrough device designation to aid in the diagnosis of infectious disease. https://kariusdx.com/resources/press-releases/karius-test-r-receives-fda-breakthrough-device-designation-to-aid-in-the-diagnosis-of-infectious-disease. Published May 16, 2024. Accessed May 16, 2024.
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