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 show that when coupled with CytoBay's proprietary stain, Techcyte's solution achieved high sensitivity and specificity rates*. 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, Ph.D., 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.