When 58-year-old leukemia patient Maria Torres spiked a fever and began struggling to breathe last winter, doctors at Johns Hopkins Hospital rushed to find the cause. Within hours, a new urine test flagged a dangerous fungal infection—giving her care team the answer they needed before her condition worsened. This test, developed by researchers in Baltimore and now FDA-cleared, is changing how doctors diagnose invasive aspergillosis, a stealthy infection that can kill up to half of high-risk patients.
Invasive aspergillosis, caused by a common mold called Aspergillus, rarely harms healthy people. But for those with weakened immune systems—like cancer patients, organ transplant recipients, or people in intensive care—it can be deadly. For years, diagnosis meant invasive procedures like lung biopsies or bronchoscopies, or waiting days for blood test results. Now, a simple urine test can deliver answers in hours.
Developed by Dr. Sean X. Zhang and his team at Johns Hopkins Medicine, the test detects unique proteins shed by the fungus in urine. In one study, it correctly identified 92% of confirmed cases—46 out of 50—using stored samples. In real-world hospital testing, it caught 86% of positive cases and ruled out 90% of negative ones. The test was validated using 290 samples collected over 13 years from patients in the U.S. and Belgium, and analyzed in labs across three American cities: Baltimore, Pittsburgh, and Raleigh.
What makes this breakthrough so vital is timing. "Having an early diagnosis is critical; it can initiate appropriate and timely treatment to help prevent disease progression and increase the odds of survival," says Dr. Zhang, who leads the Medical Mycology Laboratory at Johns Hopkins. In one recent hospital study, nearly half of the 210 patients suspected of having the infection lacked a clear diagnosis. But among those unconfirmed cases, about 1 in 4 tested positive—suggesting the urine test may catch infections that other methods miss.
The FDA cleared the test in late 2025 for use in adults, and it’s now being integrated into clinical care at major medical centers. It’s not meant to replace imaging or other tests, but to work alongside them—offering faster clarity when every hour counts. For patients with blood cancers or recovering from transplants, that speed could mean the difference between life and death.
As fungal infections become more common in vulnerable populations, tools like this offer real hope. The team in Baltimore is already exploring ways to adapt the technology for other hard-to-diagnose infections. For now, they’re focused on getting this test into more hospitals—where it can do the most good, one urine sample at a time.