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bioAffinity Technologies, Inc. filings document a public biotechnology company with common stock and tradeable warrants listed on Nasdaq. Recent reports include Form 8-K disclosures for quarterly financial information, CyPath® Lung clinical case-study announcements, annual meeting voting results, director elections, and amendments to the company’s equity incentive compensation plan.
Registration statements and current reports also describe the company’s emerging growth and smaller reporting company status, securities offerings, capital structure, and governance matters associated with its noninvasive lung-disease diagnostics business. The filing record ties operating disclosures to CyPath® Lung, Precision Pathology Laboratory Services, laboratory-developed test commercialization, and the company’s research platform for lung disease diagnostics.
bioAffinity Technologies reported that unit sales of its CyPath® Lung diagnostic test reached a record monthly level in April 2026 and increased nearly 300% compared with April 2025, based on preliminary unaudited data. Management said this growth exceeds internal projections and reflects accelerating physician adoption and broader clinical use for lung cancer risk assessment and pulmonary nodule management.
CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry and artificial intelligence to detect malignancy in high‑risk patients. In a clinical trial of patients with small indeterminate lung nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value, which can help avoid unnecessary invasive procedures when results are negative.
bioAffinity Technologies reported that unit sales of its CyPath® Lung diagnostic test reached a record monthly level in April 2026 and increased nearly 300% compared with April 2025, based on preliminary unaudited data. Management said this growth exceeds internal projections and reflects accelerating physician adoption and broader clinical use for lung cancer risk assessment and pulmonary nodule management.
CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry and artificial intelligence to detect malignancy in high‑risk patients. In a clinical trial of patients with small indeterminate lung nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value, which can help avoid unnecessary invasive procedures when results are negative.
bioAffinity Technologies reported first quarter 2026 results, with revenue of $1.4 million and a net loss of $3.6 million, or $(0.81) per share. Revenue declined mainly because the company discontinued certain unprofitable pathology services in March 2025 to focus on higher-margin offerings.
Within that strategy, CyPath® Lung performance was strong. CyPath Lung testing revenue rose about 114% to $361,000 and unit sales increased 146% year-over-year, supported by a 69% increase in ordering physician offices and clinics. Direct costs fell 32% to $0.9 million as earlier cost actions took hold.
Operating expenses grew to $5.0 million from $4.5 million, driven by higher selling, general and administrative spending to scale commercialization, while clinical development costs increased to support a large longitudinal trial funded in part by the U.S. Department of Defense. Cash and cash equivalents were $3.1 million as of March 31, 2026, down from $6.4 million at year-end 2025.
bioAffinity Technologies reported first quarter 2026 results, with revenue of $1.4 million and a net loss of $3.6 million, or $(0.81) per share. Revenue declined mainly because the company discontinued certain unprofitable pathology services in March 2025 to focus on higher-margin offerings.
Within that strategy, CyPath® Lung performance was strong. CyPath Lung testing revenue rose about 114% to $361,000 and unit sales increased 146% year-over-year, supported by a 69% increase in ordering physician offices and clinics. Direct costs fell 32% to $0.9 million as earlier cost actions took hold.
Operating expenses grew to $5.0 million from $4.5 million, driven by higher selling, general and administrative spending to scale commercialization, while clinical development costs increased to support a large longitudinal trial funded in part by the U.S. Department of Defense. Cash and cash equivalents were $3.1 million as of March 31, 2026, down from $6.4 million at year-end 2025.
bioAffinity Technologies, Inc. has filed a resale registration for up to 497,483 shares of common stock on behalf of existing investors. The shares consist of 365,603 warrant shares and 131,880 shares issuable upon conversion of Series B preferred stock after anti-dilution adjustments. The company will not sell shares in this offering and will receive no proceeds from stockholder resales, other than any cash paid if warrants are exercised. As of December 31, 2025, 4,498,675 common shares were outstanding, rising to 4,996,155 shares if all registered warrant and conversion shares are issued. bioAffinity develops noninvasive lung cancer diagnostics, including its CyPath® Lung test, which showed 92% sensitivity and 87% specificity in a clinical trial and recently posted 146% unit sales growth year over year in the first quarter of 2026.
bioAffinity Technologies, Inc. has filed a resale registration for up to 497,483 shares of common stock on behalf of existing investors. The shares consist of 365,603 warrant shares and 131,880 shares issuable upon conversion of Series B preferred stock after anti-dilution adjustments. The company will not sell shares in this offering and will receive no proceeds from stockholder resales, other than any cash paid if warrants are exercised. As of December 31, 2025, 4,498,675 common shares were outstanding, rising to 4,996,155 shares if all registered warrant and conversion shares are issued. bioAffinity develops noninvasive lung cancer diagnostics, including its CyPath® Lung test, which showed 92% sensitivity and 87% specificity in a clinical trial and recently posted 146% unit sales growth year over year in the first quarter of 2026.
bioAffinity Technologies, Inc. reported results of its 2026 Annual Meeting, where stockholders approved several equity and capital structure proposals. They expanded the 2024 Equity Incentive Compensation Plan to reserve 1,000,000 shares, up from 66,666, increasing capacity for stock-based awards. Holders also approved issuances tied to August 2025 warrants and Series B preferred stock, including anti-dilution adjustments that could add hundreds of thousands of shares upon exercise or conversion. Stockholders authorized potential non-public offerings that may trigger a change of control under Nasdaq rules and approved a discretionary 1‑for‑2 to 1‑for‑250 reverse stock split, which the board may implement or abandon. All six director nominees were elected and the independent auditor was ratified.
bioAffinity Technologies, Inc. reported results of its 2026 Annual Meeting, where stockholders approved several equity and capital structure proposals. They expanded the 2024 Equity Incentive Compensation Plan to reserve 1,000,000 shares, up from 66,666, increasing capacity for stock-based awards. Holders also approved issuances tied to August 2025 warrants and Series B preferred stock, including anti-dilution adjustments that could add hundreds of thousands of shares upon exercise or conversion. Stockholders authorized potential non-public offerings that may trigger a change of control under Nasdaq rules and approved a discretionary 1‑for‑2 to 1‑for‑250 reverse stock split, which the board may implement or abandon. All six director nominees were elected and the independent auditor was ratified.
bioAffinity Technologies, Inc. filed an update describing a new clinical case study using its CyPath® Lung diagnostic test for a high-risk patient with a suspicious 30-millimeter pulmonary nodule. Standard imaging and risk models suggested a high likelihood of lung cancer, but the treating pulmonologist suspected inflammation.
CyPath® Lung, a noninvasive sputum-based test, returned a negative result labeled “Unlikely Malignancy,” prompting additional imaging before proceeding to biopsy. A follow-up CT scan showed the nodule had completely resolved, sparing the 70-year-old patient, who had a 50 pack-year smoking history and emphysema, from a risky and potentially unnecessary invasive procedure.
The case illustrates how CyPath® Lung can support pulmonary nodule management in complex patients. The company notes that this is a single-patient experience and emphasizes prior clinical trial results in high-risk patients with small indeterminate nodules, where CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer.
bioAffinity Technologies, Inc. filed an update describing a new clinical case study using its CyPath® Lung diagnostic test for a high-risk patient with a suspicious 30-millimeter pulmonary nodule. Standard imaging and risk models suggested a high likelihood of lung cancer, but the treating pulmonologist suspected inflammation.
CyPath® Lung, a noninvasive sputum-based test, returned a negative result labeled “Unlikely Malignancy,” prompting additional imaging before proceeding to biopsy. A follow-up CT scan showed the nodule had completely resolved, sparing the 70-year-old patient, who had a 50 pack-year smoking history and emphysema, from a risky and potentially unnecessary invasive procedure.
The case illustrates how CyPath® Lung can support pulmonary nodule management in complex patients. The company notes that this is a single-patient experience and emphasizes prior clinical trial results in high-risk patients with small indeterminate nodules, where CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer.
bioAffinity Technologies, Inc. announced that its noninvasive CyPath® Lung diagnostic test will be featured at the invitation-only “Advances in Early Lung Cancer Detection” symposium at the Cleveland Clinic in Ohio on April 16, 2026. Chief Medical Officer Gordon Downie, MD, PhD, will join a panel on lung nodule management, discussing how the test supports early detection in high-risk patients.
CyPath® Lung is a sputum-based assay that uses flow cytometry and artificial intelligence to analyze the lung microenvironment and identify cancer and cancer-related cells. In patients at high risk with small indeterminate nodules under 20 millimeters, it demonstrated 92% sensitivity, 87% specificity and 88% accuracy, supporting its role as an adjunct to current diagnostic pathways. The test is marketed as a Laboratory Developed Test under CLIA through Precision Pathology Laboratory Services, a bioAffinity subsidiary.
bioAffinity Technologies, Inc. announced that its noninvasive CyPath® Lung diagnostic test will be featured at the invitation-only “Advances in Early Lung Cancer Detection” symposium at the Cleveland Clinic in Ohio on April 16, 2026. Chief Medical Officer Gordon Downie, MD, PhD, will join a panel on lung nodule management, discussing how the test supports early detection in high-risk patients.
CyPath® Lung is a sputum-based assay that uses flow cytometry and artificial intelligence to analyze the lung microenvironment and identify cancer and cancer-related cells. In patients at high risk with small indeterminate nodules under 20 millimeters, it demonstrated 92% sensitivity, 87% specificity and 88% accuracy, supporting its role as an adjunct to current diagnostic pathways. The test is marketed as a Laboratory Developed Test under CLIA through Precision Pathology Laboratory Services, a bioAffinity subsidiary.
bioAffinity Technologies, Inc. reported that unit sales of its CyPath® Lung diagnostic test in the first quarter of 2026 exceeded internal projections and, based on preliminary unaudited data, grew 146% year over year versus the first quarter of 2025. Management links this surge to accelerating physician adoption and broader clinical use of the noninvasive lung cancer diagnostic.
The company highlights a current and expanding U.S. addressable market of $3.58 billion for pulmonary nodule management and surveillance of lung cancer survivors, and notes prior audited results showing CyPath® Lung revenue rising 87% and test units sold increasing 99% in 2025. CyPath® Lung, a flow cytometry plus AI-based sputum test, previously demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high‑risk patients.
bioAffinity Technologies, Inc. reported that unit sales of its CyPath® Lung diagnostic test in the first quarter of 2026 exceeded internal projections and, based on preliminary unaudited data, grew 146% year over year versus the first quarter of 2025. Management links this surge to accelerating physician adoption and broader clinical use of the noninvasive lung cancer diagnostic.
The company highlights a current and expanding U.S. addressable market of $3.58 billion for pulmonary nodule management and surveillance of lung cancer survivors, and notes prior audited results showing CyPath® Lung revenue rising 87% and test units sold increasing 99% in 2025. CyPath® Lung, a flow cytometry plus AI-based sputum test, previously demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high‑risk patients.
bioAffinity Technologies, Inc. furnished an 8-K to share updated investor presentation materials about its operations and performance. Management plans to use these March 2026 presentation materials in future discussions, and they were posted on the company’s website on March 26, 2026.
The presentation is included as Exhibit 99.1 and is provided under Regulation FD, meaning it is furnished rather than filed and is not subject to certain Exchange Act liabilities or automatically incorporated into other securities law filings.
bioAffinity Technologies, Inc. furnished an 8-K to share updated investor presentation materials about its operations and performance. Management plans to use these March 2026 presentation materials in future discussions, and they were posted on the company’s website on March 26, 2026.
The presentation is included as Exhibit 99.1 and is provided under Regulation FD, meaning it is furnished rather than filed and is not subject to certain Exchange Act liabilities or automatically incorporated into other securities law filings.
bioAffinity Technologies filed an 8-K to highlight a live virtual physician roundtable on integrating its CyPath® Lung diagnostic test into pulmonary practice. The first “CyPath® Lung in Practice” webinar will be held on April 8, 2026, with pulmonologists presenting real-world cases where the test guided lung cancer risk assessment, nodule management, and post-treatment surveillance.
CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry, AI, and a fluorescent porphyrin to identify cell populations associated with lung cancer in high-risk patients. Clinical study results showed 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients with small indeterminate nodules less than 20 millimeters.
bioAffinity Technologies filed an 8-K to highlight a live virtual physician roundtable on integrating its CyPath® Lung diagnostic test into pulmonary practice. The first “CyPath® Lung in Practice” webinar will be held on April 8, 2026, with pulmonologists presenting real-world cases where the test guided lung cancer risk assessment, nodule management, and post-treatment surveillance.
CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry, AI, and a fluorescent porphyrin to identify cell populations associated with lung cancer in high-risk patients. Clinical study results showed 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients with small indeterminate nodules less than 20 millimeters.
bioAffinity Technologies, Inc. reported a new clinical case study evaluating its noninvasive CyPath® Lung test in a high-risk patient with multiple lung nodules. The company furnished a press release describing how the test result helped guide care and potentially avoid an invasive lung procedure.
The 71‑year‑old former smoker had several pulmonary nodules, including a 7 millimeter nodule that might normally trigger bronchoscopy or biopsy. A CyPath® Lung result indicating unlikely malignancy supported the pulmonologist’s decision to monitor with a follow‑up CT scan instead of immediately ordering an invasive procedure.
The follow‑up scan showed suspicious nodules had resolved, suggesting benign inflammation, while one small nodule remained stable. The press release notes prior clinical study performance for CyPath® Lung, with 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in high‑risk patients with small nodules under 20 millimeters.
bioAffinity Technologies, Inc. reported a new clinical case study evaluating its noninvasive CyPath® Lung test in a high-risk patient with multiple lung nodules. The company furnished a press release describing how the test result helped guide care and potentially avoid an invasive lung procedure.
The 71‑year‑old former smoker had several pulmonary nodules, including a 7 millimeter nodule that might normally trigger bronchoscopy or biopsy. A CyPath® Lung result indicating unlikely malignancy supported the pulmonologist’s decision to monitor with a follow‑up CT scan instead of immediately ordering an invasive procedure.
The follow‑up scan showed suspicious nodules had resolved, suggesting benign inflammation, while one small nodule remained stable. The press release notes prior clinical study performance for CyPath® Lung, with 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in high‑risk patients with small nodules under 20 millimeters.