Irvine, California, April 25, 2024

Promis Dx recently published a study in the Journal of Molecular Diagnostics that highlights the efficacy of EarlyTect BCD, a new diagnostic tool for detecting bladder cancer in patients. This novel urine-based test integrates advanced DNA methylation analysis technologies to offer a noninvasive alternative for identifying bladder cancer (BC), particularly among patients presenting with hematuria (blood in the urine).
Performed by an international collaboration between researchers in the United States and South Korea, the EarlyTect BCD test simplifies BC detection by combining linear target enrichment and quantitative methylation-specific PCR in a single closed tube. This approach minimizes contamination risks and enhances test accuracy. With a sensitivity of 81.0% and a specificity of 91.5%, the test has shown remarkable effectiveness in detecting BC across all stages in a diverse patient cohort.

The test is especially effective in identifying high-grade and advanced stages of BC, demonstrating a 100% sensitivity rate for such cases. Its robust performance is complemented by a high negative predictive value of 97.7%, suggesting that a negative test result reliably indicates the absence of BC, which could significantly reduce the need for invasive procedures like cystoscopy.
This groundbreaking test not only promises to improve diagnostic accuracy but also to reduce the healthcare burden associated with the traditional invasive diagnostic processes. The findings underscore the potential of DNA-based methylation tests in revolutionizing cancer diagnostics.

Read more about the study here.