The US FDA has granted BDD to Karius Test for the diagnosis of immunocompromised patients with possible lung infections such as lower respiratory infection & pneumonia
The test was being compared with SoC under the PICKUP study among adults (n=257) having hematologic malignancies or who underwent hematopoietic cell transplantation with suspected pneumonia
The study demonstrated that the Karius Test increased the pneumonia causes identification by 40%. It also detected non-pneumonia infections in 39% of individuals, supporting the ATS Workshop Report’s observation that current pneumonia definitions lack specificity and highlighting the test’s value in identifying infections regardless of pathogen or site
Ref: Karius | Image: Karius
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