bioAffinity Technologies, Inc. is a privately held development-stage company advancing proprietary screening and early‐stage diagnostic technology applicable to a broad range of cancers. The Company holds extensive U.S. and international patents that allow for global commercialization of its technology.
bioAffinity Technologies’ platform technology, trademarked under the name CyPath®, is a non-invasive test that labels cancer’s ability to stimulate its own growth by hijacking cellular processes that exist in every normal cell. As part of that labeling process, CyPath® preferentially binds to cancer cells as compared to non-cancer cells and fluoresces red under blue light.
Our first product is a non‐invasive and inexpensive test for the early detection of lung cancer. Lung cancer is the leading cancer killer worldwide, claiming nearly 1.4 million lives, more than the next four biggest cancers – colon, breast, prostate and pancreatic – combined. More than 160,000 Americans are diagnosed with the disease each year. Long-term survivability of lung cancer is extremely low. A staggering 60% of patients with lung cancer die within one year after diagnosis. Studies show that early detection can increase the survival rate to more than 90% if lung cancer is caught and treatment can begin in the earliest stage.
Current screening for lung cancer is accomplished using low dose computed tomography (LDCT) that has shown to increase survival and find earlier stage cancer as compared to x-ray screening. However, LDCT has a high false-positive rate of more than 96% and can lead to unnecessary invasive procedures. LDCT also exposes patients to radiation, so the screening method can save lives but is far from optimal.
The diagnostic process using CyPath® begins by obtaining a sputum sample from an individual. A simple assist device is used to break up mucus and help a person cough up the sample. The sputum sample is prepared for analysis and labeled with CyPath®. Cancer cells in the sample fluoresce a deep red as compared to healthy cells when viewed microscopically. CyPath®’s fluorescence takes the form of photons emitted by a labeled cell at specific wavelengths and can be objectively measured by sophisticated imaging and computer software. By comparing the photon emissions of a labeled cell, cancer can be identified.
The Company plans to develop a product line of cost-effective, reproducible and accurate assays for a variety of cancers based on adaptations of this platform technology.
The discussion and conclusions concerning the bioAffinity Technologies, Inc. screening and diagnostic technology presented in this website are based on the results of studies and investigations. bioAffinity Technologies, Inc.’s screening and diagnostic technology has not received any regulatory approvals and is not commercially available for sale.