bioAffinity Technologies, Inc. is a privately held company incorporated in Delaware addressing the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targeted cancer treatment. Our Company develops proprietary noninvasive diagnostic tests and cancer therapeutics using technology that preferentially targets cancer cells and cell populations indicative of a diseased state. Research and optimization of our platform technologies are conducted in our laboratories at The University of Texas at San Antonio. We are developing our platform technologies so that, in the future, they will be able to detect and monitor diseases of the lung and other cancers and treat many cancers. More than 100 different types of cancers have been identified, all marked by the abnormal and unrestricted proliferation of cells that can eventually kill a patient stricken with the disease. Lung, breast, prostate, and colorectal cancers are the most common, representing more than half of all cancer diagnoses. Lung cancer alone, by far the deadliest, is responsible for an estimated 1.8 million deaths worldwide annually(1). A patient’s overall cancer survivability depends on the type of cancer and the stage at which cancer is treated. The early diagnosis of cancer, before it spreads, is a significant contributor to survival. This is true for lung cancer that is most often detected in later stage when the cancer has spread to other parts of the body. However, if lung cancer is detected and treated early (Stage I), the current overall five-year survival rate of 20.5%(2) for Stages II-IV can leap to a 10-year survival rate of 92%(3). Current diagnostic protocols include lab tests, various imaging techniques, and biopsy followed by microscopic examination of tissue samples. None of these methods perfectly detects cancer cells, especially in the early stages of the disease. Low-dose computed tomography (LDCT) is recommended for screening patients at high risk for lung cancer. Results of a large clinical trial of more than 53,000 patients showed that screening for lung cancer by LDCT lowered the mortality rate by 20% as compared to x-ray imaging(4),(5). However, the study found that of every 100 people screened for lung cancer who received a positive LDCT result, fewer than four of those individuals truly had the disease. Consequently, there is a great and urgent need for better targeted diagnostic methods that are safe, accurate, rapid, noninvasive, and cost effective for the detection of early-stage lung cancer. Our first diagnostic test, CyPath® Lung, addresses the need for early detection of lung cancer, the leading cause of cancer-related deaths. In order to identify patients more confidently who need to undergo more invasive follow-up procedures, physicians will be able to order CyPath® Lung to assist in the assessment of the potential for the disease. CyPath®Lung thus serves as another tool in the physician’s decision-making process to distinguish between patients who are likely to have lung cancer and will benefit from timely intervention and those who are likely without disease and should continue their annual screening for lung cancer. CyPath® Lung is a noninvasive test for the early detection of lung cancer. Our test uses flow cytometry to analyze the different type of cells in a person’s sputum, or phlegm from the lungs, to find characteristics indicative of lung cancer, including cancer and cancer-related cells that have shed from a lung tumor. Flow cytometry is a technology to group cells into populations of cells that look similar, based on their size, internal structures, and the presence of certain molecules on the outside or inside of the cell. Flow cytometry does this one cell at a time, scanning a large number of cells in a relatively short time period. For example, an average sputum sample containing about 20 million cells can be profiled cell-by-cell by flow cytometry in less than 20 minutes using the CyPath® Lung protocol. To collect a sputum sample, a patient blows into a hand-held, noninvasive assist device that acts to break up mucus in the lungs and help a person cough up the sputum from the lung into a collection cup. The sputum sample is shipped overnight to the laboratory and processed in accordance with CyPath® Lung protocol. Sample processing includes labeling cells with a synthetic porphyrin that attaches to cancer and cancer-associated cells (specifically, the porphyrin called meso-tetra (4-carboxyphenyl) porphine or “TCPP”). Sample processing also includes the use of antibodies that attach to specific types of cells. The processed sputum sample is run through a flow cytometer that can identify cancer and cancer-related cells labeled by TCPP and other cell populations. The resulting data is automatically analyzed immediately after data acquisition by proprietary automated analysis software that is fully integrated into the test and generates both quantitative and qualitative diagnostic results in the form of a patient report that is provided to the ordering physician. CyPath® Lung has the potential to increase overall diagnostic accuracy of lung cancer leading to increased survival, lower the number of unnecessary invasive procedures, reduce patient anxiety, and lower medical costs(6). bioAffinity Technologies intends to develop the CyPath® platform technology for use in the detection of other lung diseases, such as chronic obstructive pulmonary disease (“COPD”) and asthma. The Company further intends to develop tests to detect other cancers, including prostate cancer at an early stage, and to monitor for recurrence of bladder cancer. Through our wholly owned subsidiary, OncoSelect® Therapeutics, LLC, our Company is focused on expanding its broad platform technologies to create targeted therapeutics to fight cancer. In researching how TCPP, the porphyrin used in CyPath® Lung, enters cancer cells, we discovered a novel potential therapy that kills cancer cells that have been grown in petri dishes without apparent harm to normal cells. This approach uses RNA interference (“RNAi”), a natural mechanism for selectively silencing (eliminating or “knocking down”) a gene. Genes provide cells with instructions for making proteins, and silencing a gene by RNAi refers to stopping or reducing production of the protein specified by that gene. We discovered that treating cells in the laboratory with certain small interfering RNAs (“siRNAs,” which are short, chemically synthesized nucleic acid molecules), we can silence the two genes and thereby the production of two cell-surface proteins, causing potent and selective cancer cell death while leaving normal cells virtually unharmed. Our potential therapies will be achieved, in part, by advancing studies of the siRNA-driven silencing of two genes encoding for the cell surface proteins CD320 and LRP2. We found that silencing these two genes resulted in cell death in multiple human cancer cell lines, including lung, breast, prostate, melanoma, and brain cancer cell lines, but left normal human fibroblast and breast epithelial cells virtually unaffected. (1) The Cancer Atlas, Third Edition, American Cancer Society (ACS), World Health Organization (WHO) and The Union for International Cancer Control (UICC); https://canceratlas.cancer.org/the-burden/lung-cancer/. (2) SEER Cancer Statistics Review, 1975–2018; https://seer.cancer.gov/statfacts/html/lungb.htm. (3) The International Early Lung Cancer Action Program Investigators, Survival of Patients with Stage I Lung Cancer Detected on CT Screening. N. Engl. J. Med. 2006;355:1763-71. (4) Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N. Engl. J. Med. 2011;365:395-409. (5) Church TR, Black WC, Aberle DR, et al. Results of initial low-dose computed tomographic screening for lung cancer. N. Engl. J. Med. 2013;368:1980-1991. (6) Analysis of the Potential Diagnostic, Patient And Economic Impact of CyPath® Lung When Used After LDCT Screening to Detect Lung Cancer, bioAffinity Technologies Internal Analysis with citations, 2022; attached as Appendix I of this prospectus. We were incorporated in the State of Delaware on March 26, 2014. Our principal executive office is located at 22211 West Interstate 10, Suite 1206, San Antonio, Texas 78257, and our telephone number at that address is (210) 698-5334. Our laboratory diagnostic and therapeutic research is conducted at The Harvey Sandler Cancer Research Laboratories, which is located at Science Research Laboratories, Suite 1.424, University of Texas at San Antonio, San Antonio, Texas.
AI Generated Analysis | Feedback
An Exact Sciences (Cologuard) for early lung cancer detection.
A Guardant Health for early lung cancer detection, using sputum instead of blood.
AI Generated Analysis | Feedback
- CyPath® Lung: A non-invasive diagnostic test designed for the early detection of lung cancer using sputum samples.
AI Generated Analysis | Feedback
Company: bioAffinity Technologies (Symbol: BIAF)
bioAffinity Technologies (BIAF) operates a CLIA-certified laboratory where it performs its proprietary CyPath® Lung test for the early detection of lung cancer. The company generates revenue by providing these diagnostic services and billing for them directly.
Based on their latest SEC filings, bioAffinity Technologies does not have major customer companies in a traditional business-to-business (B2B) sense that purchase their products or services for their own operations or resale. For instance, their 2023 10-K filing explicitly states that no single customer accounted for more than 10% of their revenue in either 2023 or 2022.
Instead, bioAffinity Technologies sells its diagnostic service primarily to individuals (patients) through their ordering physicians, with payment coming from various sources within the healthcare ecosystem. The primary categories of economic customers (those responsible for payment) that bioAffinity Technologies serves are:
- Healthcare Insurers (Private Payors): These include various commercial health insurance companies (e.g., UnitedHealthcare, Anthem, Aetna, Cigna) that reimburse bioAffinity Technologies for the diagnostic testing services provided to their policyholders.
- Governmental Healthcare Programs (Public Payors): These consist of government-administered programs such as Medicare and Medicaid, which provide coverage for eligible patients who utilize the CyPath® Lung test.
- Patients/Individuals: Patients themselves are responsible for a portion of the cost of the test, which may include co-payments, deductibles, or the full out-of-pocket expense if they are uninsured or if the test is not covered by their plan.
AI Generated Analysis | Feedback
Bio-Techne Corporation (NASDAQ: TECH)
AI Generated Analysis | Feedback
bioAffinity Technologies Management Team
Maria Zannes, President, Chief Executive Officer and Director
Ms. Zannes brings over 30 years of executive-level management experience. Prior to her current role, she founded The Zannes Firm, focusing on strategic solutions for private industry in medical, environmental, and energy fields. She also served as President of the Energy Recovery Council and General Manager of ECOS Corporation, a subsidiary of Burlington Environmental. Additionally, Ms. Zannes was a project manager at Wheelabrator Technologies, Inc. and is a co-founder of two engineering research centers at Columbia University. She began her career as a journalist.
J. Michael Edwards, Chief Financial Officer and Principal Accounting Officer
Mr. Edwards has over three decades of experience in financial management and business strategy. He previously served as a consulting Chief Financial Officer for bioAffinity Technologies until 2023, before rejoining the management team. Earlier in his career, Mr. Edwards was the CFO of CytoBioscience Inc., which develops and manufactures instruments for disease analysis and treatment, and OncoVista Innovative Therapies, Inc., a biopharmaceutical company focusing on targeted anticancer therapies.
Steven Girgenti, Executive Chairman
Mr. Girgenti is a veteran healthcare executive with expertise in healthcare marketing strategies, financing, and mergers and acquisitions. He has served as Executive Chairman of bioAffinity Technologies since November 2014. Mr. Girgenti is currently the Managing Partner of Medi-Pharm Consulting, LLC. He was also the CEO and co-founder of DermWorx Incorporated and the founder and CEO of Healthworld Corporation, a global healthcare marketing services network, until 2008. Under his leadership, Healthworld made numerous acquisitions and went public in 1997.
David Elzi, PhD, Vice President, Product Development
Dr. Elzi brings 20-25 years of research experience in cancer biology, molecular and cellular biology, and biochemistry to bioAffinity Technologies, which he joined in 2016. He leads research on the mechanism of porphyrin uptake in cancer cells. Previously, he held roles as a Director of Basic and Applied Research at The UT Health Science Center at San Antonio (UTHSCSA) and was a research scientist at the Greehey Children's Cancer Research Institute. Dr. Elzi earned his PhD in Molecular and Cellular Biology from the University of Washington.
Timothy P. Zannes, JD, Executive Vice President, General Counsel and Secretary
Mr. Zannes has served as corporate legal counsel for both public and private biomedical firms for over 16 years. In addition to his legal duties, he is responsible for corporate compliance and directs Human Resources. Prior to receiving his J.D., Mr. Zannes ran his own private investigation firm. He is the brother of Maria Zannes.
AI Generated Analysis | Feedback
The primary clear emerging threat to bioAffinity Technologies (BIAF) is the rapid advancement and potential widespread adoption of blood-based liquid biopsy technologies for early lung cancer detection. While BIAF's XpertDerm (a sputum-based test) offers a non-invasive alternative, the convenience of a simple blood draw offered by liquid biopsy tests (e.g., for circulating tumor DNA or other biomarkers) presents a significant competitive advantage. Companies like GRAIL, Guardant Health, and Exact Sciences are investing heavily in and developing these technologies, with some already in the market for other indications or in advanced clinical trials for early cancer detection, including lung cancer. If these blood-based tests demonstrate sufficient sensitivity, specificity, and clinical utility for early lung cancer screening, they could become the preferred non-invasive method, potentially diminishing the market opportunity for sputum-based alternatives like XpertDerm.
AI Generated Analysis | Feedback
bioAffinity Technologies (NASDAQ: BIAF) focuses on noninvasive diagnostics for early-stage cancer and lung diseases, with a pipeline in targeted cancer therapeutics. Its main product is CyPath® Lung, a noninvasive diagnostic test for the detection of early-stage lung cancer.
Addressable Markets:
- Lung Cancer Diagnostics: The global lung cancer diagnostics market was estimated at USD 12.37 billion in 2024 and is projected to reach USD 23.31 billion by 2033, growing at a CAGR of 7.5% from 2025 to 2033. Another estimate projects the global market to grow from USD 15.1 billion in 2023 to over USD 34.8 billion by 2034, at a CAGR of 7.9%. For the U.S. specifically, the lung cancer diagnostics market size was estimated at USD 2.16 billion in 2024 and is expected to be worth around USD 4.10 billion by 2034, growing at a CAGR of 6.62% from 2025 to 2034. Another source indicates the U.S. lung cancer diagnostics market size was estimated at USD 4.779 billion in 2024 and is projected to be worth around USD 10.414 billion by 2034, growing at a CAGR of 8.1% from 2025 to 2034. The lung cancer diagnostics market is also projected to reach USD 4.7 billion by 2030.
- Early-Stage Lung Cancer Diagnostics: The global early-stage lung cancer diagnostics therapy market is projected to grow from USD 2.5 billion in 2025 to USD 6.5 billion by 2035, at a CAGR of 10.0%.
- Non-Small Cell Lung Cancer (NSCLC) Diagnostics: The global non-small cell lung cancer diagnostics market is expected to reach USD 3.463 billion by 2028 from USD 1.291 billion in 2020, growing at a CAGR of 13.2% from 2021 to 2028. The global non-small cell lung cancer market was estimated at USD 20.2 billion in 2024 and is expected to grow from USD 22.1 billion in 2025 to USD 53.9 billion in 2034, at a CAGR of 10.4% from 2025 to 2034. The U.S. non-small cell lung cancer market was valued at USD 8.2 billion in 2024.
- Lung Cancer Screening: The global lung cancer screening market size was valued at USD 3.28 billion in 2023 and is projected to grow to USD 7.10 billion by 2032, exhibiting a CAGR of 9.1% from 2024 to 2032. The U.S. lung cancer screening market size is projected to reach an estimated value of USD 3.83 billion by 2032. The lung cancer screening market is projected to reach USD 5.7 billion by 2030.
- COPD and Asthma Diagnostics: bioAffinity Technologies is developing diagnostics for COPD and asthma. The combined global market for COPD and asthma diagnostics is expected to reach USD 8.2 billion by 2027. These programs target multi-billion-dollar markets and affect over 80 million people across the U.S., EU, and China.
AI Generated Analysis | Feedback
Expected Drivers of Future Revenue Growth for bioAffinity Technologies (BIAF)
Over the next two to three years, bioAffinity Technologies (BIAF) is expected to drive future revenue growth primarily through the expanded commercialization and adoption of its noninvasive lung cancer diagnostic test, CyPath® Lung, alongside strategic market expansion and the potential introduction of new diagnostic products.
The key drivers include:
* Increased Adoption and Integration of CyPath® Lung: The company has reported record growth in CyPath® Lung test volume, reflecting increasing physician confidence and the test's clinical value in detecting early-stage lung cancer and avoiding unnecessary invasive procedures. This growing adoption by healthcare providers, including Veterans' hospitals, and its increasing integration into clinical practice are crucial for sustained revenue growth.
* Expansion into New Geographic Markets: bioAffinity Technologies is actively expanding its market presence beyond its successful pilot program in Texas, with particular focus on the mid-Atlantic region and the Veterans Administration healthcare system. This strategic market expansion aims to reach a broader base of clinicians and patients, further increasing CyPath® Lung sales.
* Enhanced Payer Coverage and Patient Access: The company is building a strong foundation for long-term revenue growth by focusing on improving payer coverage and patient access for CyPath® Lung. The addition of the test to the U.S. Federal Supply Schedule in 2024 has already enhanced access for veterans and military personnel. Additionally, an increase in the list price of CyPath® Lung to $2,900 aligns with private payer reimbursement strategies, aiming to enhance per-test profitability.
* Advancement of New Diagnostic Products: Beyond CyPath® Lung, bioAffinity Technologies is committed to advancing new diagnostics for other lung diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. While CyPath® Lung is the current primary revenue driver, the development and eventual launch of these new diagnostic products represent a potential future revenue stream and diversification strategy.
* Clinical Utility and Physician Validation: Real-world case studies demonstrating CyPath® Lung's ability to detect Stage 1A lung cancer in patients where other diagnostics suggested a low probability of cancer, and to spare patients from invasive procedures, are fueling growing physician trust and demand for the test. This ongoing clinical validation and the resulting increased demand are expected to continue driving sales volume.
AI Generated Analysis | Feedback
Share Issuance
- In September 2025, bioAffinity Technologies completed a public offering, generating aggregate gross proceeds of approximately $4.8 million.
- In May 2025, the company raised approximately $3.25 million through a public offering.
- In October 2025, bioAffinity Technologies closed a registered direct offering of 720,000 shares of common stock at $2.50 per share, resulting in approximately $1.8 million in gross proceeds.
Inbound Investments
- In August 2025, bioAffinity Technologies entered into securities purchase agreements with institutional and accredited investors for a private placement of Series B Convertible Preferred Stock and warrants, expecting aggregate gross proceeds of approximately $1.2 million.
