bioAffinity Technologies, Inc..
BIAF.US | Research and experimental development on natural sciences and engineering
bioAffinity Technologies, Inc. is a biotechnology company focused on developing innovative cancer diagnostics and therapies. Its lead product, CyPath Lung, is a non-invasive diagnostic test for early-stage lung cancer using flow cytometry and proprietary biomarkers found in patient sputum. The compa...Show More
Better Health for All
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The company's core business is developing innovative cancer diagnostics and therapeutics, with its lead product, CyPath Lung, a non-invasive test for early-stage lung cancer.
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Clinical studies show CyPath Lung has 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small nodules, aiming to improve survival and reduce unnecessary invasive procedures.
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The company has no revenue from products with established negative health outcomes. The Precision Pathology Services Laboratory is CLIA certified since 1988
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and maintains CAP Accreditation as of January 7, 2026.
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However, CyPath Lung has not been cleared or approved by the FDA.
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The list price of CyPath Lung was increased to $2,900,
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and while an economic study projects cost savings of $2,773 per Medicare patient and $6,460 per private-payer patient,
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there is no information on affordability relative to median local income.
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CyPath Lung was awarded listing on the U.S. Federal Supply Schedule in October 2024, making it available to U.S. Veterans and active military personnel.
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The company is focused on research and experimental development in natural sciences and engineering,
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with R&D expenses of $311,000 in Q2 2025 and clinical development expenses increasing to $129,000 in Q2 2025.
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The use of CyPath Lung could reduce costs by $2,733 per Medicare patient and $6,460 per private insurance patient.
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The company emphasizes early detection and annual screening for lung cancer.
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Flow cytometry and an AI-developed algorithm are used for identifying malignancies in the CyPath Lung test.
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The company holds 17 patents globally and has 30 pending patent applications.
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BioAffinity is preparing for a clinical trial for CyPath Lung, recruiting upward of 3,200 patients,
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and submitted its pivotal clinical trial protocol to the Sterling Institutional Review Board (IRB) in March 2025.
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Fair Money & Economic Opportunity
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No evidence available to assess bioAffinity Technologies, Inc. on Fair Money & Economic Opportunity.
Fair Pay & Worker Respect
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No specific, quantitative data is available across the provided articles to assess bioAffinity Technologies against any of the Fair Pay & Worker Respect KPIs. While CEO compensation figures are mentioned, median employee compensation is not, preventing the calculation of the CEO median pay ratio.
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Qualitative statements about a positive work environment from a single review are not sufficient to score the worker engagement KPI, which requires a numerical index.
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Furthermore, there is no evidence regarding living wage coverage, collective bargaining share, safety incident rate, pay equity ratio, turnover rate, labor violation incidents, insecure contract share, or health insurance coverage.
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Fair Trade & Ethical Sourcing
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No evidence available to assess bioAffinity Technologies, Inc. on Fair Trade & Ethical Sourcing.
Honest & Fair Business
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The company has not incurred any ethics-related regulatory fines in the past three years. However, it received notices from Nasdaq in February 2025 regarding non-compliance with the Minimum Bid Price Rule and Continued Listing Equity Requirement, leading to a mandatory panel monitor for one year.
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Management assessed the effectiveness of internal control over financial reporting as of December 31, 2024, and disclosure controls and procedures as of September 30, 2025, concluding they were effective.
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The company has a Code of Business Conduct and a Code of Ethics, adopted in May 2018, which promotes honest and ethical conduct, compliance with laws, and fair dealing practices, and prohibits loans to or guarantees of obligations of directors or executive officers.
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There are no material pending legal proceedings.
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Kind to Animals
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The company is researching novel therapies using in vitro methods, but animal studies are planned for these therapies.
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This indicates a reliance on animal testing for future development. No evidence of cruelty-free certifications, humane certifications, wildlife conservation impact, ethical input substitution, supplier audits, cage-free sourcing, animal testing volume, innovation investment, animal agriculture ethics, animal-free R&D collaboration, or public policy engagement was found.
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No War, No Weapons
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No evidence available to assess bioAffinity Technologies, Inc. on No War, No Weapons.
Planet-Friendly Business
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No specific, concrete data points related to environmental performance metrics such as greenhouse gas emissions, renewable energy usage, water consumption, waste diversion, or other sustainability indicators were found in the provided articles. The articles primarily contain administrative information about company filings and a general statement about insufficient evidence to determine a value score for Planet-Friendly Business.
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Respect for Cultures & Communities
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Based on the provided articles and materiality analysis, there is insufficient evidence to assess bioAffinity Technologies' alignment with the value of Respect for Cultures & Communities. The company's business model, focused on diagnostic testing for lung cancer, has a low level of materiality regarding this value, as its operations do not inherently involve direct interaction with or impact on indigenous populations or cultural heritage sites. The provided articles focus on business investments and partnerships with the American Cancer Society and do not contain any information related to community engagement, cultural sensitivity, or any of the listed KPIs.
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Therefore, a score of 0 is assigned, reflecting the absence of relevant evidence. The materiality analysis confirms that scores above the neutral range would be illogical without specific evidence of community engagement or cultural preservation efforts.
Safe & Smart Tech
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No evidence available to assess bioAffinity Technologies, Inc. on Safe & Smart Tech.
Zero Waste & Sustainable Products
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No evidence available to assess bioAffinity Technologies, Inc. on Zero Waste & Sustainable Products.