bioAffinity Technologies Inc (NASDAQ: BIAF) will soon have an Australian patent in hand for its ‘CyPath Lung’ cancer test. It is the company’s first commercial product.
On Wednesday, bioAffinity announced that its patent application designated as “Detection of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning” had been accepted by the nation’s patent office.
The CyPath Lung cancer screening test requires patients to spit into a cup every 24 hours for three days. It then gets analyzed in a lab with AI and a laser analysis technique called flow cytometry. CyPath Lung serves as a valuable follow-up screening measure after low-dose CT scans — the only lung cancer diagnostics method currently approved by the FDA.
bioAffinity also obtained a Japanese patent for CyPath Lung at the end of October. The Australian license, coming in Q2, will be the company’s second international IP protection certification for the test. It has demonstrated an 88 per cent level of accuracy in multiple clinical studies.
“The Australian patent is another milestone that increases our market and strengthens our potential to improve the outcome for lung cancer patients around the globe through earlier detection,” chief executive, Maria Zannes, said in a press release. She recently attended the National Lung Cancer Roundtable event in Atlanta to shmooze with leading experts in the field.
The market for lung cancer diagnostics tests like these is expected to reach a US$4.7-billion-dollar valuation by the end of the decade, bioAffinity has estimated.
CyPath Lung; breath analysis tools like the OneBreath device developed by Breath Diagnostics; blood biopsies, and other minimally invasive screening technologies are expected to become increasingly popular.
CyPath Lung patient Steve T. on how our noninvasive test for early-stage lung cancer complements low dose CT screening.#CyPathLung#LungCancer#lungcancerscreening#LDCT pic.twitter.com/DGH7DGZlxW
— bioAffinity Technologies (@bioAffinity) January 17, 2025
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bioAffinity sold over 600 tests in Texas last year
The oncology operator used its home state for a pilot marketing program in 2024, selling hundreds of CyPath Lung kits to local physicians.
Healthcare professionals in other states like California, Florida and Arizona have been using the sputum analysis too.
bioAffinity is also making the test available to veterans throughout the United States through its addition to the Federal Supply Schedule service. The Veterans Health Administration and Military Health System are gaining access.
Those with a combat or military background are more likely to contract the disease than others.
“We already see more and more physicians and pulmonary practices incorporating CyPath Lung into their practices,” Zannes said earlier this month, “and we are excited that this year we will launch sales to veteran and military medical systems.”
Our friends at @Nasdaq put #BIAF and #CyPathLung on the iconic Nasdaq Tower today in honor of our recent announcement that CyPath Lung will be available on the Federal Supply Schedule for VA & DOD healthcare systems. #lungcancer #NASDAQ #lungcancerdiagnostics #pulmonology pic.twitter.com/OtfwOdkkhq
— bioAffinity Technologies (@bioAffinity) October 17, 2024
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