Karius Reports the US FDA’s Breakthrough Device Designation for its Karius Test to Diagnose Infectious Disease
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
