BioAffinity Partners with Brooke Army Medical Center to Validate CyPath Lung Test
BioAffinity Technologies announced a study with Brooke Army Medical Center to validate the clinical utility of using the CyPath Lung diagnostic test to assess sputum samples obtained by tracheal and bronchial suctioning for early detection of lung cancer. "Clinicians who have patients scheduled to undergo diagnostic bronchoscopy have told us that CyPath Lung could be very helpful by providing an independent and complementary test for diagnosis," said Gordon Downie, chief medical officer of BioAffinity Technologies.
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bioAffinity Technologies Unveils New Diagnostic Advances for Asthma Treatment
- New Diagnostic Technology: bioAffinity Technologies presented its innovative diagnostic approach at the AAAAI Annual Meeting, capable of identifying antibody drug receptors in sputum for asthma therapies, particularly dupilumab and benralizumab, aimed at enhancing personalized treatment decisions for asthma and COPD patients.
- Clinical Application Prospects: The research findings will assist physicians in matching the most effective therapies for asthma and COPD patients while monitoring inflammatory changes, thereby improving treatment outcomes and reducing healthcare costs, potentially benefiting approximately 650 million patients globally.
- Platform Advantages: bioAffinity leverages its proprietary flow cytometry platform and automated AI analysis to develop tests that rapidly match patients with biologic therapies, further advancing its applications in non-invasive early cancer detection.
- CyPath® Lung Test: The CyPath® Lung test by bioAffinity demonstrates 92% sensitivity and 87% specificity in detecting early lung cancer, showcasing its effectiveness in high-risk patients and solidifying the company's market position in lung disease diagnostics.
CyPath® Lung Test Supports Noninvasive Surveillance Strategy
- Noninvasive Testing Advantage: bioAffinity Technologies' CyPath® Lung test demonstrates 92% sensitivity and 87% specificity for detecting lung cancer in nodules smaller than 2 centimeters, significantly reducing the need for invasive biopsies in high-risk patients, thereby enhancing patient safety and treatment confidence.
- Clinical Case Support: In a case involving a 79-year-old female patient, despite a suspicious nodule on a low-dose CT scan, the negative result from CyPath® Lung allowed physicians to avoid a high-risk biopsy, supporting a conservative monitoring strategy that highlights the test's importance in clinical decision-making.
- Monitoring Strategy Optimization: Based on the results from CyPath® Lung, the patient and her care team opted to continue with annual CT scans, ensuring ongoing surveillance for potential lung cancer while avoiding unnecessary invasive procedures, thus reducing healthcare costs and alleviating patient anxiety.
- Innovative Technology Outlook: CyPath® Lung utilizes advanced flow cytometry and artificial intelligence for early lung cancer detection in high-risk patients, marking a significant advancement in the biotechnology field for noninvasive cancer diagnostics and indicating broad future application potential in early cancer detection.
bioAffinity Showcases CyPath® Lung Cancer Detection Technology with 92% Sensitivity
- Technology Showcase: bioAffinity's Chief Medical Officer, Gordon Downie, will present at the American Cancer Society's National Lung Cancer Roundtable, highlighting CyPath® Lung's success in identifying three cases of Stage 1A lung cancer, demonstrating its effectiveness in complex cases.
- Clinical Challenges: Faced with uncertain lung nodule diagnoses, CyPath® Lung, in conjunction with low-dose CT and PET imaging, provides clear results that assist physicians in confirming diagnoses at early stages, thereby enhancing treatment opportunities for patients.
- Sensitivity and Accuracy: CyPath® Lung exhibits a 92% sensitivity and 88% accuracy in high-risk patients, underscoring its significance in early lung cancer detection, which can significantly improve patient survival rates.
- Industry Collaboration: This presentation occurs at the NLCRT meeting, which includes 194 medical and public health organizations, emphasizing bioAffinity's leadership in lung cancer diagnostics and fostering collaboration and innovation within the industry.
bioAffinity Technologies Sees Rapid Month-Over-Month Increase in CyPath® Lung Test Volume
Sales Growth of CyPath® Lung: bioAffinity Technologies reported a 111% increase in test volume for its noninvasive lung cancer diagnostic test, CyPath® Lung, in October 2025 compared to the monthly average for the first nine months of the year, indicating strong adoption by physicians.
Clinical Value Recognition: The increase in test volume reflects growing recognition among clinicians of the test's clinical value in early lung cancer detection, particularly for patients with indeterminate pulmonary nodules.
Consistent Growth Trends: Throughout 2025, CyPath® Lung has shown consistent month-over-month and quarter-over-quarter sales growth, with a 95% increase in third-quarter sales compared to the previous quarter.
Technology and Accuracy: CyPath® Lung utilizes advanced flow cytometry and AI for detecting malignancy in sputum samples, achieving 92% sensitivity and 88% accuracy in clinical studies, which underscores its potential to improve early-stage lung cancer diagnosis and patient outcomes.
bioAffinity Technologies, Inc. Completes $1.8 Million Registered Direct Offering of Common Stock at Market Price in Accordance with Nasdaq Regulations
Stock Offering Announcement: bioAffinity Technologies, Inc. has completed a registered direct offering of 720,000 shares of common stock at $2.50 per share, with proceeds intended for working capital and to support sales growth of its noninvasive lung cancer test, CyPath® Lung.
Company Overview: bioAffinity Technologies focuses on noninvasive cancer diagnostics, with its primary product, CyPath® Lung, demonstrating high sensitivity and accuracy for early-stage lung cancer detection, marketed through its subsidiary, Precision Pathology Laboratory Services.
WallachBeth Capital Announces The Closing of bioAffinity Technologies $1.8M Registered Direct Financing of Common Stock Priced At-The-Market Under Nasdaq Rules
Stock Offering Announcement: bioAffinity Technologies, Inc. has completed a registered direct offering of 720,000 shares of common stock at $2.50 per share, facilitated by WallachBeth Capital LLC as the sole placement agent.
Use of Proceeds: The funds raised will be utilized for working capital, supporting sales growth for their noninvasive lung cancer test, CyPath® Lung, and for general corporate purposes.
bioAffinity Technologies Unveils New Diagnostic Advances for Asthma Treatment
- New Diagnostic Technology: bioAffinity Technologies presented its innovative diagnostic approach at the AAAAI Annual Meeting, capable of identifying antibody drug receptors in sputum for asthma therapies, particularly dupilumab and benralizumab, aimed at enhancing personalized treatment decisions for asthma and COPD patients.
- Clinical Application Prospects: The research findings will assist physicians in matching the most effective therapies for asthma and COPD patients while monitoring inflammatory changes, thereby improving treatment outcomes and reducing healthcare costs, potentially benefiting approximately 650 million patients globally.
- Platform Advantages: bioAffinity leverages its proprietary flow cytometry platform and automated AI analysis to develop tests that rapidly match patients with biologic therapies, further advancing its applications in non-invasive early cancer detection.
- CyPath® Lung Test: The CyPath® Lung test by bioAffinity demonstrates 92% sensitivity and 87% specificity in detecting early lung cancer, showcasing its effectiveness in high-risk patients and solidifying the company's market position in lung disease diagnostics.
CyPath® Lung Test Supports Noninvasive Surveillance Strategy
- Noninvasive Testing Advantage: bioAffinity Technologies' CyPath® Lung test demonstrates 92% sensitivity and 87% specificity for detecting lung cancer in nodules smaller than 2 centimeters, significantly reducing the need for invasive biopsies in high-risk patients, thereby enhancing patient safety and treatment confidence.
- Clinical Case Support: In a case involving a 79-year-old female patient, despite a suspicious nodule on a low-dose CT scan, the negative result from CyPath® Lung allowed physicians to avoid a high-risk biopsy, supporting a conservative monitoring strategy that highlights the test's importance in clinical decision-making.
- Monitoring Strategy Optimization: Based on the results from CyPath® Lung, the patient and her care team opted to continue with annual CT scans, ensuring ongoing surveillance for potential lung cancer while avoiding unnecessary invasive procedures, thus reducing healthcare costs and alleviating patient anxiety.
- Innovative Technology Outlook: CyPath® Lung utilizes advanced flow cytometry and artificial intelligence for early lung cancer detection in high-risk patients, marking a significant advancement in the biotechnology field for noninvasive cancer diagnostics and indicating broad future application potential in early cancer detection.
bioAffinity Showcases CyPath® Lung Cancer Detection Technology with 92% Sensitivity
- Technology Showcase: bioAffinity's Chief Medical Officer, Gordon Downie, will present at the American Cancer Society's National Lung Cancer Roundtable, highlighting CyPath® Lung's success in identifying three cases of Stage 1A lung cancer, demonstrating its effectiveness in complex cases.
- Clinical Challenges: Faced with uncertain lung nodule diagnoses, CyPath® Lung, in conjunction with low-dose CT and PET imaging, provides clear results that assist physicians in confirming diagnoses at early stages, thereby enhancing treatment opportunities for patients.
- Sensitivity and Accuracy: CyPath® Lung exhibits a 92% sensitivity and 88% accuracy in high-risk patients, underscoring its significance in early lung cancer detection, which can significantly improve patient survival rates.
- Industry Collaboration: This presentation occurs at the NLCRT meeting, which includes 194 medical and public health organizations, emphasizing bioAffinity's leadership in lung cancer diagnostics and fostering collaboration and innovation within the industry.
bioAffinity Technologies Sees Rapid Month-Over-Month Increase in CyPath® Lung Test Volume
Sales Growth of CyPath® Lung: bioAffinity Technologies reported a 111% increase in test volume for its noninvasive lung cancer diagnostic test, CyPath® Lung, in October 2025 compared to the monthly average for the first nine months of the year, indicating strong adoption by physicians.
Clinical Value Recognition: The increase in test volume reflects growing recognition among clinicians of the test's clinical value in early lung cancer detection, particularly for patients with indeterminate pulmonary nodules.
Consistent Growth Trends: Throughout 2025, CyPath® Lung has shown consistent month-over-month and quarter-over-quarter sales growth, with a 95% increase in third-quarter sales compared to the previous quarter.
Technology and Accuracy: CyPath® Lung utilizes advanced flow cytometry and AI for detecting malignancy in sputum samples, achieving 92% sensitivity and 88% accuracy in clinical studies, which underscores its potential to improve early-stage lung cancer diagnosis and patient outcomes.
bioAffinity Technologies, Inc. Completes $1.8 Million Registered Direct Offering of Common Stock at Market Price in Accordance with Nasdaq Regulations
Stock Offering Announcement: bioAffinity Technologies, Inc. has completed a registered direct offering of 720,000 shares of common stock at $2.50 per share, with proceeds intended for working capital and to support sales growth of its noninvasive lung cancer test, CyPath® Lung.
Company Overview: bioAffinity Technologies focuses on noninvasive cancer diagnostics, with its primary product, CyPath® Lung, demonstrating high sensitivity and accuracy for early-stage lung cancer detection, marketed through its subsidiary, Precision Pathology Laboratory Services.
WallachBeth Capital Announces The Closing of bioAffinity Technologies $1.8M Registered Direct Financing of Common Stock Priced At-The-Market Under Nasdaq Rules
Stock Offering Announcement: bioAffinity Technologies, Inc. has completed a registered direct offering of 720,000 shares of common stock at $2.50 per share, facilitated by WallachBeth Capital LLC as the sole placement agent.
Use of Proceeds: The funds raised will be utilized for working capital, supporting sales growth for their noninvasive lung cancer test, CyPath® Lung, and for general corporate purposes.
