The Vesta Bladder Risk Stratify Dx uses artificial intelligence to analyze routine pathology slides and assess patient risk.
Valar Labs announced that the US Food and Drug Administration (FDA) granted Breakthrough Device Designation to its Vesta Bladder Risk Stratify Dx, an AI-powered digital pathology prognostic test for bladder cancer.
The test applies proprietary AI foundation models to standard hematoxylin and eosin (H&E) stained pathology slides. These slides are produced as part of routine clinical care to generate risk assessments for patients.
“Vesta Bladder has been a breakthrough in biomarker driven oncology by serving a population of patients that previously had limited access to precision medicine,” says Anirudh Joshi, CEO of Valar Labs, in a release.
The majority of bladder cancer cases are diagnosed at the non-muscle-invasive stage. While these tumors are often treatable, their clinical behavior is varied. Some cases remain indolent while others progress to muscle-invasive disease. Currently, clinicians rely on features such as grade, stage, and tumor size to estimate risk, but these tools can leave uncertainty in treatment planning, according to the company.
“For decades, urologists have managed bladder cancer with prognostic tools that leave too many patients in the gray zone — Vesta Bladder Risk Stratify Dx gives clinicians the resolution they need to match treatment intensity to each patient’s true biological risk,” says Trevor Royce, MD, chief medical officer of Valar Labs, in a release.
The FDA Breakthrough Device Program is intended to expedite the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. Devices in the program receive prioritized interaction and review from the FDA to potentially speed up clearance and patient access.
The company’s technology also supports a portfolio of AI-powered lab developed tests for bladder, prostate, and pancreatic cancer. These tests are available through the company’s CLIA-certified and CAP-accredited laboratory.
