Valar Labs’ Vesta Bladder Risk Stratify Dx has secured breakthrough device designation from the US Food and Drug Administration (FDA), becoming the first artificial intelligence (AI)-based digital pathology prognostic test in bladder cancer to receive the tag.
The California-based company’s Vesta Bladder Risk Stratify Dx applies artificial intelligence (AI) models to standard haematoxylin and eosin (H&E) stained pathology slides to generate a risk assessment for bladder cancer patients. It is hoped that these risk scores can help inform treatment decisions.
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Valar’s Vesta platform, the underlying technology of which also powers laboratory developed tests (LDTs) in prostate and pancreatic cancer, is designed to support clinicians at key decision points across the cancer care continuum, the company stated, from initial risk assessment through treatment selection. This is achieved by extracting predictive signals from pathology images that are not visible to the human eye, the company added.
A majority of bladder cancer patients are diagnosed at the non-muscle-invasive stage. While these tumours are often treatable, they are often also highly heterogeneous in their clinical behaviour, with some patients experiencing indolent disease that may never progress, with others facing aggressive recurrence and progression to muscle-invasive disease.
Clinicians rely primarily on clinical and pathologic features such as grade, stage, and tumour size to assess individual bladder cancers’ risk profile; however, while valuable, Valar believes there is room to improve.
Trevor Royce, CMO at Valar Labs, states that for decades, bladder cancer has been managed with prognostic tools that leave patients “in the grey zone”, with Vesta Bladder intended to provide clinicians with the “resolution they need to match treatment intensity to each patient’s true biological risk”.
Bladder cancer is the tenth leading cause of cancer death in the US. The American Cancer Society (ACS) forecasts that there will be around 84,530 new cases and 17,870 deaths caused by the disease in the US in 2026.
Valar Labs CEO Anirudh Joshi commented: “Vesta Bladder has been a breakthrough in biomarker driven oncology by serving a population of patients that previously had limited access to precision medicine.”
AI is having a large impact in the healthcare space, taking up a particularly dominant role in the medical imaging space. According to a report by GlobalData, the combined AI market across healthcare was valued at $11.9bn in 2024 and is expected to reach a valuation of $57.4bn in 2029.
