bioAffinity Tech Stock Price, News & Analysis

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) is a biotechnology company that focuses on noninvasive diagnostics and the early detection of lung cancer and other lung diseases. According to the company’s public disclosures, bioAffinity Technologies addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and is advancing early-stage cancer diagnostics and broad-spectrum cancer treatments. Its work is positioned within the biotechnology and professional, scientific, and technical services sector.

The company’s first commercial product, CyPath® Lung, is described as a noninvasive test for the detection of early-stage lung cancer in patients at high risk for the disease. Multiple company press releases and SEC filings state that CyPath® Lung has demonstrated high sensitivity, specificity and accuracy in clinical studies for detecting lung cancer in patients with small lung nodules less than 20 millimeters. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services (PPLS), a wholly owned laboratory subsidiary of bioAffinity Technologies.

Core technology and diagnostic approach

bioAffinity Technologies reports that CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to analyze sputum samples from patients. The test identifies cell populations in patient sputum that indicate malignancy, including cancer and cancer-related cells and other cell types associated with disease. The company explains that CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells, and that automated data analysis helps determine whether cancer is present or if the patient is cancer-free.

In company communications, clinical study results for CyPath® Lung are reported to show 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in high-risk patients with small indeterminate lung nodules. bioAffinity Technologies highlights that detecting lung cancer at early stages, such as Stage 1A, can allow treatment when it is potentially curative and may improve patient outcomes.

Subsidiary laboratory and service offerings

bioAffinity Technologies operates through its subsidiary Precision Pathology Laboratory Services, which is described as a wholly owned laboratory that delivers pathology services to physicians in a variety of outpatient settings. Public disclosures state that PPLS generates revenue from anatomic and clinical pathology services and serves as a foundation for the long-term growth of the CyPath® Lung diagnostic test. The laboratory’s offerings include anatomic pathology, morphological staining, histological services and molecular testing, in addition to processing CyPath® Lung tests.

Precision Pathology Laboratory Services is accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA). bioAffinity Technologies has announced that PPLS has successfully maintained CAP accreditation following rigorous on-site inspections, which the company characterizes as the gold standard for laboratory quality, accuracy and patient safety. The company links this accreditation to support for the quality and reliability of CyPath® Lung and other diagnostic services.

Intellectual property and platform development

bioAffinity Technologies emphasizes the role of intellectual property in its business. The company reports an expanding global patent estate that includes awarded and pending patents in the United States and multiple international jurisdictions. According to company announcements, bioAffinity holds patents in countries such as the U.S., Australia, Canada, China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden and the United Kingdom, among others.

The company has disclosed a notification of allowance from the United States Patent and Trademark Office for a patent titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.” This patent covers a system and method for predicting the likelihood of lung cancer by analyzing patient sputum samples with an AI-built algorithm and a flow cytometry platform. bioAffinity states that this technology detects changes in the lung linked to cancer, including populations of immune cells, apoptotic cells and cancer and cancer-related cells labeled by the company’s proprietary TCPP porphyrin, and combines these variables with patient age to predict cancer in the lung.

In addition, the company has announced that the Australian Patent Office has accepted a patent application titled “System and Method for Determining Lung Health.” This application covers methods that use flow cytometry combined with fluorescent probes, described as molecular tags that attach to specific cell types, to detect cellular and molecular signatures of multiple lung diseases. bioAffinity Technologies presents this as evidence of the broader potential of its platform technology to assess lung health and predict the likelihood of multiple lung diseases.

Clinical and real-world use of CyPath® Lung

bioAffinity Technologies has highlighted real-world clinical use cases for CyPath® Lung. Company materials describe cases in which CyPath® Lung successfully identified Stage 1A lung cancer in patients with atypical and diagnostically challenging presentations, including patients with indeterminate pulmonary nodules and conflicting or inconclusive diagnostic data from other tools. In these reports, CyPath® Lung was used alongside low-dose CT (LDCT), PET imaging, risk calculators, bronchoscopy and blood serum marker tests and was described as providing clarity and actionable results that contributed to early diagnosis.

The company has also reported accelerating growth in CyPath® Lung test volume and revenues, driven by higher test volumes and growing clinical adoption. According to its public statements, bioAffinity Technologies has seen increased use of CyPath® Lung by physicians, including adoption by Veterans Administration (VA) medical centers and expansion into additional geographic markets. The company links this growth to outreach efforts to pulmonologists, health systems and VA medical centers and to the perceived clinical value of CyPath® Lung in detecting lung cancer at early and more treatable stages.

Market context and focus on lung cancer diagnostics

bioAffinity Technologies cites third-party estimates of the U.S. lung cancer diagnostics market to frame the potential opportunity for CyPath® Lung. In one public release, the company notes that the U.S. lung cancer diagnostics market size was valued at approximately $4.8 billion in 2024 and, based on a stated compound annual growth rate, is projected to reach $10.4 billion by 2034. Within this context, the company positions CyPath® Lung as addressing an urgent unmet need for noninvasive early-stage lung cancer diagnosis.

Company communications also reference the clinical burden of indeterminate pulmonary nodules, particularly when clinicians face conflicting or inconclusive diagnostic data. bioAffinity Technologies presents CyPath® Lung as a tool that can be incorporated into the diagnostic pathway to help determine next steps for patients with pulmonary nodules requiring follow-up, potentially reducing unnecessary invasive procedures and associated risks.

Corporate status and listing

bioAffinity Technologies, Inc. is incorporated in Delaware and lists its principal executive offices in San Antonio, Texas in SEC filings. The company’s common stock and tradeable warrants are listed on the Nasdaq Capital Market under the symbols BIAF and BIAFW, respectively. The company has disclosed that it is an emerging growth company under applicable SEC definitions.

In 2025, bioAffinity Technologies reported that it had regained compliance with Nasdaq listing requirements, including the minimum bid price rule and minimum stockholders’ equity rule. Nasdaq correspondence referenced by the company indicates that BIAF and BIAFW remain listed on the Nasdaq Capital Market, subject to a mandatory panel monitor period.

Capital raising and corporate governance

bioAffinity Technologies has used registered offerings and private placements to fund its operations and growth initiatives. The company has reported raising gross proceeds through equity transactions, including a registered direct offering of common stock under an effective shelf registration statement on Form S-3. Public filings describe the use of proceeds as working capital, support for growing CyPath® Lung sales and general corporate purposes.

The company also files proxy materials and other governance-related documents with the SEC. In a definitive proxy statement, bioAffinity Technologies outlined proposals related to warrant exercises and anti-dilution provisions, preferred stock terms, amendments to an equity incentive plan, potential non-public offerings under Nasdaq rules and related change-of-control considerations. These materials reflect the company’s efforts to manage its capital structure and equity-based compensation.

Research, conferences and professional engagement

bioAffinity Technologies participates in scientific and medical forums to present data on CyPath® Lung and its diagnostic platform. The company has announced presentations at meetings such as CHEST, the annual meeting of the American College of Chest Physicians, and the American Cancer Society National Lung Cancer Roundtable. Topics have included the effect of sputum storage and shipping temperature on flow cytometric outcomes of sputum-based diagnostic tests and case-based posters illustrating how CyPath® Lung contributed to early-stage lung cancer diagnoses in complex clinical scenarios.

Through these activities, bioAffinity Technologies highlights the scientific rigor applied to sample collection, transport and processing for CyPath® Lung, and seeks to engage physicians and healthcare professionals in discussions about noninvasive diagnostics for lung cancer and other lung diseases.