Early Detection and Treatment Saves Lives

Fluorescencing cancer cell

A cancer cell with an intense red fluorescence (left arrow) in contrast to a non-cancer cell, both in a single cancer patient sputum sample labeled with CyPath®

Addressing A Critical Need to Find Lung Cancer Early
bioAffinity Technologies, Inc. develops assays, or tests, to detect and treat cancer at the molecular level. CyPath® Lung, bioAffinity Technologies’ first product, is being developed for the detection of early-stage 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 sample of sputum, or phlegm, 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.

CyPath® has the ability to dramatically increase overall accuracy of screening and reduce unnecessary invasive procedures and patient anxiety, as well as lower medical costs.

Treating Cancer with Targeted Therapies
Through its subsidiary, OncoSelect Therapeutics, the Company is focusing on expanding its broad platform technology to create targeted porphyrin therapeutics to fight cancer. Chemotherapy and other cancer-killing drugs can be attached to CyPath® that is taken up by cancerous tumors in much greater amounts than by non-cancer tissue. OncoSelect Therapeutics will be developing a diverse number of targeted therapeutics based on the platform technology to provide novel drugs in the fight against cancer.

Expanding the Platform to Diagnose Other Cancers and Propel Cancer Research
bioAffinity Technologies is working to harness CyPath®’s ability to identify and zero in on individual cancer cells for use in detecting other cancers, such as bladder, prostate and cervical cancers

CyPath® Bladder will be developed to meet a major need in the treatment of bladder cancer patients, specifically non-invasive monitoring to detect recurrences early and prevent the muscle-invasive progression of cancer. Bladder cancer strikes 75,000 individuals in the U.S. each year, and about 15,000 people die annually from the disease. Bladder cancer has the highest cancer recurrence rate, ranging between 31-78% within five years of initial diagnosis. The risk of recurrence continues for a lifetime. Early diagnosis and routine monitoring is key to survival.

Prostate cancer is the second most common cancer in men and the fourth leading cancer-related killer, with more than 300,000 deaths and 1.1 million cases diagnosed worldwide as reported in 2012. Unfortunately, the accuracy of detection for prostate cancer is relatively low. CyPath® Prostate will be developed as a non-invasive test with a higher sensitivity and positive predictive value than current diagnostic options as well as the ability to check for biomarkers that are associated with bad prognostic tumors to improve the outcome of patients.

CyPath® Cervix will be developed as a more accurate diagnostic tool than the current gold standard of the widely used PAP screening test. Early-stage diagnosis of cervical cancer results in a five-year survival rate of 90.0%. But similar to other cancers, diagnosis in the late stages drops to a 16.1% five-year survival rate.

CyPath® also presents a substantial opportunity to study cancer cells at their earliest stages to better understand cancer progression at the molecular level. Easy labeling and subsequent isolation of cancer cells is fundamental to state-of-the-art cancer research. CyPath® may be used as a research tool in isolating cancer at its various stages and cell types. Research tools to identify and isolate cancer cells and better understand cell morphology are fundamental to the development of new products in the screening, diagnosis, treatment, and monitoring of cancer.