FDA Clears First Rapid Urine Test for Serious Fungal Infection
What Happened
Researchers at Johns Hopkins Medicine published data supporting an FDA-cleared urine test that can help diagnose invasive aspergillosis, a potentially life-threatening fungal infection that mainly affects people with weakened immune systems. The test, cleared by the FDA in late 2025, directly detects Aspergillus antigens in urine and can deliver results within a few hours, offering a less invasive alternative to procedures such as bronchoscopy and tissue biopsy.
Key Takeaways
Earlier diagnosis could enable faster treatment and improve survival chances for high-risk patients. Researchers say the test is believed to be the first FDA-cleared rapid urine-based assay for invasive aspergillosis.