New Urine Test for Bladder Cancer Earns FDA Breakthrough Status

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A new urine-based test for bladder cancer just received a major boost from the U.S. Food and Drug Administration (FDA).

On June 30, 2025, biotech company TOBY, Inc. announced that its TOBY Test has been granted breakthrough device designation by the FDA. This special status is reserved for medical technologies that offer patients a more effective or less invasive option compared with current standards.

“This designation validates the potential of our one-step urine test to detect bladder cancer at its most treatable stage,” Matthew Laskowski, chief executive officer of TOBY, said in a statement. “We now have a unique opportunity to work more closely with the FDA, accelerate our clinical development, and make early, accessible and affordable cancer screening a reality.”

Bladder cancer is the sixth most common cancer in the United States and is known for its high recurrence rate. Traditionally, patients are monitored using cystoscopy — a procedure where doctors insert a camera through the urethra to check the bladder. While effective, cystoscopy is invasive, uncomfortable and expensive.

TOBY’s new test offers a low-cost, noninvasive alternative. It works by analyzing volatile organic compounds (VOCs) found in a single urine sample. Using advanced tools like gas chromatography-mass spectrometry and artificial intelligence (AI), the test generates a real-time cancer risk score for each patient.

Receiving breakthrough device designation means TOBY’s test will benefit from faster FDA review and more frequent communication with the agency during the approval process. This could help bring the test to patients sooner.

In addition to bladder cancer, TOBY is planning future clinical studies to explore the use of its technology for detecting other types of cancer. The hope is that this innovative platform will one day support large-scale cancer screening using a simple urine sample.

“This milestone is a leap forward not only for TOBY but for the patients and clinicians we aim to serve,” Laskowski stated. “We founded TOBY to uncover what conventional methods often miss. With FDA’s support, we’re one step closer to making early cancer detection effortless and accessible for everyone.”