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Techcyte and CytoBay Complete Initial Validation Studies for AI-Powered Bladder Cancer Screening Solution

January 2023

Techcyte is proud to announce the completion of initial validation studies for its artificial intelligence-powered Bladder Cancer screening solution. These studies suggest that its deep machine-learning algorithm is capable of classifying objects of interest and detecting cancerous cells. Validation studies were conducted using samples treated with a proprietary staining technique developed by CytoBay Labs, Techcyte’s development partner for this product.

“Our goal at Techcyte is to create a comprehensive AI model to assist lab professionals in making more accurate and efficient reads,” says Chris Summerhays, Techcyte Product Manager. “We are excited to be one step closer to being able to do that for bladder cancer screening tests with the completion of our initial AI validation and clinical studies.” 

Initial results from a single hospital-based clinical study of 150 patients with various clinical conditions show that when coupled with CytoBay’s proprietary stain, Techcyte’s solution achieved a sensitivity of up to 98% and specificity of up to 85%*. Additional laboratory validation will now be conducted to further prove the test’s efficiency and accuracy.

“We are pleased with the initial results,” says Dr. Wenjiang Chu, MD, PhD, CytoBay Founder. “The success we’ve seen in combining Techcyte’s technology with CytoBay’s proprietary staining solution is promising. It’s proving to be reliable, cost-effective, and convenient for lab professionals and patients alike.”

In 2022, 870,910 bladder cancer survivors in the U.S. needed recurring cancer surveillance. The current gold standard for this type of surveillance is invasive, costly, and time-consuming, leaving many survivors to opt out of the procedure. 

This partnership will introduce the first Bladder Cancer screening test coupled with AI; however, the product requires further validation. It is still in the research phase as it progresses towards a full clinical validation and a FDA submission. The goal is to use the product to provide initial results for those who have no prior diagnosis and maintenance results for those who have had cancer, gone through treatment, and require recurring surveillance tests. If a positive result is found through Techcyte’s urine test, future biopsies can then be conducted.

Techcyte and CytoBay’s Bladder Cancer Screening Solution is for Research Use Only and is in the data gathering and study design phase. It has not been evaluated by the FDA, and Techcyte plans to perform a broader study before submitting for FDA clearance. 

*This claim has not yet been examined by the FDA.

About Techcyte

Techcyte, Inc. was founded in 2013 in Orem, Utah and is the world leader in AI-based cellular digital diagnostics. Techcyte’s Clinical Pathology AI Platform uses deep machine learning to perform automated analysis of whole slide microscopy images, revolutionizing digital diagnostics for human, animal, and environmental clinics and labs.

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Techcyte’s clinical pathology platform is for Research Use Only in the United States.

About Cytobay

Founded in Los Angeles in 2020, Cytobay Laboratories, Inc. is on the leading edge of Next Generation Cancer Diagnostics. Cytobay Laboratories’ proprietary staining technology revolutionizes cancer testing to make it more reliable, cost-effective, and convenient.