San Antonio — [Updated 10/11/18, 11 a.m. See below.] BioAffinity Technologies has signed a licensing agreement with San Antonio-based Precision Pathology Services for the continued development and commercial sale of a lung cancer diagnostic screening test.
Since bioAffinity moved to San Antonio in 2014, it has been developing CyPath Lung, a noninvasive test that analyzes sputum—mucus from deep in the lung—for cancer cells. The company uses a compound that binds to cancer cells and flouresces, helping bioAffinity detect cancer in the lungs, according to CEO Maria Zannes.
Precision Pathology Services, a pathology and testing business, will develop bioAffinity’s technology as the company finishes a validation trial of CyPath that it hopes to use to be certified as a Laboratory Developed Test. That’s a type of device that is used in a single laboratory and generally not required to undergo premarket review and testing by the FDA.
Precision Pathology would also work with bioAffinity on selling the diagnostic, if it reaches the market. The company is seeking to launch sales of CyPath Lung in the first quarter of 2019, Zannes said in a news release. While Precision has licensed the right to further develop and sell CyPath, bioAffinity can also continue developing the product and license it to other labs, which it plans to do in both the U.S. and Europe, Zannes wrote in an e-mail. [Updated with comments from Zannes throughout.]
The diagnostic would be used after a patient has already received a positive result for lung cancer from low dose computed tomography (LDCT) screening, bioAffinity says. LDCT screenings have a high rate of false positive results, which can lead to anything from expensive scans to invasive procedures such as a lung biopsy, bioAffinity says. (The company claims four in 100 people with a positive LDCT result will actually have lung cancer.)
BioAffinity said in May it was in the process of raising $5 million in new funding to commercialization its diagnostic and to fund its therapeutics development arm, OncoSelect Therapeutics. That work is based on the knowledge of how and why bioAffinity’s diagnostic compound is selectively taken up by cancer cells, Zannes wrote in an e-mail at the time. The company is planning animal studies for 2019. BioAffinity has continued raising funds in the form of a convertible note, which will convert into a $20 million Series B Preferred offering that may close in the second quarter of 2019, Zannes wrote in an e-mail this week. The company announced a $4 million Series A funding round in July 2017.
BioAffinity is also developing tests for prostate and bladder cancers. The company expects to begin proof-of-concept trials after commercializing CyPath Lung, Zannes wrote this week.