AUGUST 11, 2020
As published in the San Antonio Business Journal
By W. Scott Bailey – Senior Reporter, San Antonio Business Journal
A local pathology practice has initiated a validation study of San Antonio-based bioAffinity Technologies’ CyPath Lung early detection cancer test. The validation study is needed for bioAffinity to commercialize the product, which is its first.
It’s a significant step for the privately held biotech company, whose CEO, Maria Zannes, has worked for more than six years to reach this stage, moving to the Alamo City from New Mexico to launch bioAffinity in March 2014.
Precision Pathology Services, also based in San Antonio, is conducting the validation study. Precision Pathology previously licensed bioAffinity’s intellectual property as part of a larger plan to secure laboratory developed test, or LDT, status for CyPath Lung. Having completed that development phase, it now needs to complete validation testing before November to sell the technology.
“This is the final step before commercialization, before being able to market the test,” Zannes told me.
The validation work could have been completed sooner, Zannes said, were it not for disruptions caused by Covid-19. She expects bioAffinity to begin selling its cancer detection test this year.
Stakeholders expect there will be plenty of demand for the CyPath Lung test.
“Lung cancer is the leading cancer killer,” said Dr. Roby Joyce, president of Precision Pathology. “Our test for early detection of this dreaded disease can help many people live longer and healthier lives.”
The validation study is being conducted in accordance with College of American Pathologists guidelines and Clinical Laboratory Improvement Amendments regulations. They’ve been designed to establish and validate performance characteristics of CyPath Lung — including accuracy, precision, reproducibility and analytical sensitivity — which are necessary to move to commercialization.
Once CyPath Lung is verified as an LDT, physicians will be able to order the test for patients at high risk for lung cancer who receive a positive screening result or who are otherwise suspected of having the disease.
“Precision will be able to sell to their physicians and the patients they serve,” Zannes said, noting that the initial rollout will be mostly regional.
The long-term plan calls for more widespread national distribution. There are international opportunities also, as bioAffinity holds patents in several countries. Zannes believes the CyPath Lung product is just a starting point.
“Looking beyond lung cancer, we believe our automated platform can be successfully applied to cancer diagnostic tests for several other cancers, which will improve overall survival rates for patients through early diagnosis and treatment,” she said.