bioAffinity Receives Patent Allowance for Lung Cancer Prediction in Mexico
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 27 2026
0mins
bioAffinity Technologies announced it has received notification of allowance from the Mexican Institute of Industrial Property for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry. Upon issuance, the Mexican patent application will protect the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum. "This patent expands our global intellectual property portfolio and protection of CyPath Lung's proprietary approach to detecting lung cancer at its earliest and most treatable stages," said Maria Zannes, President and CEO of bioAffinity Technologies. "The integration of advanced cell biology, flow cytometry and AI into an easy-to-use, noninvasive test clearly differentiates our technology, which is designed to support clinicians in evaluating indeterminate pulmonary nodules and high-risk patients."
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About BIAF
bioAffinity Technologies, Inc. is a biotechnology company focused on the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. It develops noninvasive diagnostics to detect early-stage lung cancer and other diseases of the lung using flow cytometry and automated analysis developed by machine learning, a form of artificial intelligence (AI). The Company’s product, CyPath Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of the Company. CyPath Lung uses flow cytometry technology to detect and analyze cell populations in a person’s sputum, or phlegm, to find characteristics indicative of lung cancer, including cancer and/or cancer-related cells that have shed from a lung tumor.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Addressing Clinical Needs: The rise in patients identified with indeterminate pulmonary nodules, partly due to increased low-dose CT screenings, highlights the diagnostic challenges faced by physicians, which CyPath® Lung's flow cytometry and AI technology aims to alleviate by providing actionable insights for early lung cancer detection.
- Focused Commercial Strategy: bioAffinity Technologies has prioritized CyPath® Lung as its core focus, driving growth through the expansion of ordering physician sites, enhanced peer-to-peer education among pulmonologists, and integration into clinical workflows, thereby improving lung cancer risk management.
- Future Expansion Plans: The company is advancing multiple initiatives to enhance the clinical impact of its proprietary technology platform, including a large-scale longitudinal clinical study and broader use of CyPath® Lung for monitoring lung cancer survivors, demonstrating its commitment to early cancer detection and market potential.
See More
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- Revenue Decline: The company generated $1.35 million in revenue for the first quarter, a significant drop from $6.2 million in the same period last year, suggesting a potential weakening in market demand that could impact future growth prospects.
- Liquidity Concerns: As of March 31, 2026, cash and cash equivalents stood at $3.1 million, down from $6.4 million as of December 31, 2025, highlighting urgent issues in cash management and operational sustainability.
- Clinical Integration Efforts: bioAffinity Technologies is discussing the clinical integration of its CyPath lung product in pulmonary nodule assessment and early lung cancer diagnosis, which, despite poor financial results, may pave the way for future market opportunities.
See More
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- Revenue Changes: CyPath® Lung testing revenue reached approximately $361,000, a 114% increase, while total revenue decreased by 27% to $1.4 million, primarily due to the discontinuation of unprofitable pathology services, allowing a focus on higher-margin CyPath® Lung testing.
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See More
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- Financial Performance: The significant drop in revenue indicates potential challenges for the company in maintaining financial stability and growth.
See More
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- Earnings Per Share: The company's earnings per share stood at $0.81.
See More
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- Clinical Trial Design: The study aims to enroll approximately 40 participants across asthma, COPD, and healthy control groups, utilizing automated analysis of sputum samples to identify and measure specific immune cell populations, thereby guiding personalized treatment and enhancing therapeutic effectiveness.
- Innovative Technology Application: The integration of bioAffinity's flow cytometry and AI technology allows for cellular-level assessment of lung inflammation, enabling physicians to more accurately match treatment strategies, thereby advancing the shift towards a precision medicine model and improving long-term patient health outcomes.
- Military Health Impact: Successful outcomes from this study could provide the military with a safe and reliable non-invasive method for assessing lung inflammation, potentially improving respiratory health for service members and veterans, which may influence their readiness and deployment decisions.
See More
CyPath®Lung Sales Surge Nearly 300% in April 2026
- Sales Surge: bioAffinity Technologies reported that unit sales of its CyPath® Lung diagnostic test increased nearly 300% in April 2026 compared to the same month in 2025, based on preliminary unaudited data, indicating strong physician adoption and exceeding internal projections.
- Addressing Clinical Needs: The rise in patients identified with indeterminate pulmonary nodules, partly due to increased low-dose CT screenings, highlights the diagnostic challenges faced by physicians, which CyPath® Lung's flow cytometry and AI technology aims to alleviate by providing actionable insights for early lung cancer detection.
- Focused Commercial Strategy: bioAffinity Technologies has prioritized CyPath® Lung as its core focus, driving growth through the expansion of ordering physician sites, enhanced peer-to-peer education among pulmonologists, and integration into clinical workflows, thereby improving lung cancer risk management.
- Future Expansion Plans: The company is advancing multiple initiatives to enhance the clinical impact of its proprietary technology platform, including a large-scale longitudinal clinical study and broader use of CyPath® Lung for monitoring lung cancer survivors, demonstrating its commitment to early cancer detection and market potential.
See More
bioAffinity Technologies Reports Q1 Financial Results
- Financial Performance: bioAffinity Technologies reported a Q1 GAAP EPS of -$0.81, indicating ongoing challenges in profitability and reflecting persistent financial pressure on the company.
- Revenue Decline: The company generated $1.35 million in revenue for the first quarter, a significant drop from $6.2 million in the same period last year, suggesting a potential weakening in market demand that could impact future growth prospects.
- Liquidity Concerns: As of March 31, 2026, cash and cash equivalents stood at $3.1 million, down from $6.4 million as of December 31, 2025, highlighting urgent issues in cash management and operational sustainability.
- Clinical Integration Efforts: bioAffinity Technologies is discussing the clinical integration of its CyPath lung product in pulmonary nodule assessment and early lung cancer diagnosis, which, despite poor financial results, may pave the way for future market opportunities.
See More
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- Significant Sales Growth: In Q1 2026, CyPath® Lung diagnostic unit sales surged 146% year-over-year, reflecting rapid physician adoption and expanded clinical use, thereby enhancing the company's competitive edge in the non-invasive lung cancer detection market.
- Revenue Changes: CyPath® Lung testing revenue reached approximately $361,000, a 114% increase, while total revenue decreased by 27% to $1.4 million, primarily due to the discontinuation of unprofitable pathology services, allowing a focus on higher-margin CyPath® Lung testing.
- Clinical Trial Launch: The company initiated a large-scale longitudinal clinical trial, partially funded by the U.S. Department of Defense, expected to include up to 20 clinical sites, aimed at further validating CyPath® Lung's performance and establishing it as a standard of care in military and Veterans Administration medical centers.
- Strategic Investment and Market Expansion: bioAffinity Technologies plans to conduct a 40-patient collaborative study with Brooke Army Medical Center, utilizing its flow cytometry + AI technology to evaluate its platform's application in personalized therapy, further driving market acceptance of CyPath® Lung.
See More
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- Revenue Decline: BioAffinity Technologies reported a 27% decrease in consolidated revenue, totaling $1.4 million in Q1 2026.
- Financial Performance: The significant drop in revenue indicates potential challenges for the company in maintaining financial stability and growth.
See More
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- Financial Performance: BioAffinity Technologies reported a net loss of $3.6 million for the first quarter of 2026.
- Earnings Per Share: The company's earnings per share stood at $0.81.
See More
bioAffinity Partners with Military Medical Center to Develop Respiratory Disease Diagnostics
- Research Collaboration Initiated: bioAffinity Technologies has partnered with the Brooke Army Medical Center, the largest military medical center in the U.S., to evaluate its non-invasive diagnostic tests for respiratory diseases, which could significantly impact the asthma and COPD market projected at $92 billion.
- Clinical Trial Design: The study aims to enroll approximately 40 participants across asthma, COPD, and healthy control groups, utilizing automated analysis of sputum samples to identify and measure specific immune cell populations, thereby guiding personalized treatment and enhancing therapeutic effectiveness.
- Innovative Technology Application: The integration of bioAffinity's flow cytometry and AI technology allows for cellular-level assessment of lung inflammation, enabling physicians to more accurately match treatment strategies, thereby advancing the shift towards a precision medicine model and improving long-term patient health outcomes.
- Military Health Impact: Successful outcomes from this study could provide the military with a safe and reliable non-invasive method for assessing lung inflammation, potentially improving respiratory health for service members and veterans, which may influence their readiness and deployment decisions.
See More
