Irvine, California, September 15, 2025

Promis Diagnostics today announced that its flagship bladder cancer test, EarlyTect^® BCD (PLA 0452U), has been highlighted in the 2025 American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Microhematuria Guideline as one of the urinary biomarkers with strong negative predictive value (NPV) for ruling out bladder cancer in patients with microhematuria.
In the updated guideline, the Panel reinforced the use of urine cytology and validated urinary biomarkers as optional tools for intermediate-risk microhematuria patients who wish to avoid cystoscopy. EarlyTect BCD demonstrated an NPV of 97.6%–98.7% across 1,465 patients, one of the largest validation cohorts reported among urine-based tests.

Key Strengths Recognized

– High Negative Predictive Value
With nearly 99% NPV, EarlyTect BCD provides physicians with confidence to safely defer cystoscopy in appropriately selected patients intermediate risk population.
– Validated in Large Diverse Cohorts
As shown in the AUA/SUFU guideline table of validated urinary biomarkers, EarlyTect^® BCD is validated in the largest study population to date among urine-based bladder cancer tests — over 1,400 patients across both microhematuria and gross hematuria cohorts — underscoring its unmatched real-world applicability.
– Clinical Alignment with AUA Guideline Pathway
The updated guideline specifically enables the use of validated biomarkers for intermediate-risk microhematuria. In this setting, EarlyTect^® BCD is uniquely positioned to reduce unnecessary invasive cystoscopies while ensuring patient safety and physician confidence.

EarlyTect^® BCD’s NPV values in the AUA/SUFU Guidelines are not only comparable but demonstrate strong performance alongside other validated urinary biomarkers. While the reported values may appear conservative due to the high prevalence of bladder cancer (19.9%) in the cohort, this reflects the patient population studied rather than test performance. Because NPV increases as prevalence decreases, EarlyTect^® BCD achieves NPVs exceeding 99% in lower-prevalence settings that reflect real-world urology practice (2–10%), aligning with or surpassing peer assays. This recognition underscores EarlyTect^® BCD’s reliability across diverse hematuria populations..

With its recognition in the 2025 AUA/SUFU Microhematuria Guideline, EarlyTect^® BCD represents a major step forward in providing patients and physicians with a reliable option for bladder cancer evaluation. Promis Diagnostics is committed to further expanding the clinical evidence base and working toward broader adoption and reimbursement to ensure patients benefit from early, accurate and non-invasive testing.

For a more detailed article, read here: https://www.auanet.org/guidelines-and-quality/guidelines/microhematuria