bioAffinity Tech Stock Price, News & Analysis

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

The company’s first commercial product, CyPath® Lung, is described as a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer in patients at high risk for the disease. bioAffinity states that CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by its subsidiary Precision Pathology Laboratory Services (PPLS. The test is designed to improve early detection of lung cancer in patients with small lung nodules or other risk factors.

CyPath® Lung diagnostic technology

Company materials explain that CyPath® Lung uses advanced flow cytometry combined with proprietary artificial intelligence (AI) to analyze patient sputum. The technology identifies cell populations that indicate malignancy, including cancer and cancer‑related cells, immune cells and apoptotic cells. CyPath® Lung incorporates a fluorescent porphyrin (TCPP) that is preferentially taken up by cancer and cancer‑related cells. Automated data analysis then helps determine whether cancer is present or if the patient is cancer‑free.

Clinical study results reported by bioAffinity show that CyPath® Lung achieved 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in high‑risk patients who had small lung nodules less than 20 millimeters. The company highlights that detecting lung cancer at Stage 1A, a potentially curative stage, can improve outcomes and increase patient survival, and that CyPath® Lung has been used in case studies where lung cancer was identified at this earliest stage.

Subsidiary laboratory and pathology services

bioAffinity’s wholly owned subsidiary, Precision Pathology Laboratory Services (PPLS), delivers pathology services to physicians in a variety of outpatient settings. Public descriptions of PPLS note that, in addition to CyPath® Lung, its laboratory offerings include anatomic pathology, morphological staining, histological services and molecular testing. PPLS is accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA), which the company states supports high standards of accuracy and reliability across its service lines.

bioAffinity reports that it acquired PPLS and that the subsidiary has generated revenue from anatomic and clinical pathology services. The company has also disclosed strategic actions to discontinue certain unprofitable pathology services and reallocate resources toward commercialization of CyPath® Lung, identifying this test as its flagship or key growth driver.

Intellectual property and platform development

The company emphasizes a growing global patent estate around its diagnostic platform. Public announcements describe multiple awarded and pending patents in the United States and other jurisdictions. These include a U.S. patent titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning”, which covers the AI‑built algorithm and flow cytometry platform that analyzes sputum cell populations to predict the likelihood of lung cancer.

bioAffinity has also reported acceptance of an Australian patent application titled “System and Method for Determining Lung Health”. This application covers methods that use flow cytometry combined with fluorescent probes, or molecular tags, to detect cellular and molecular signatures of multiple lung diseases in sputum samples. Company statements describe this as a platform for assessing lung health and predicting the likelihood of multiple lung diseases, and they position CyPath® Lung as the centerpiece of current commercial efforts built on this platform.

Regulatory and listing status

According to filings with the U.S. Securities and Exchange Commission (SEC), bioAffinity Technologies, Inc. is incorporated in Delaware and has its principal executive offices in San Antonio, Texas. The company’s common stock trades on the Nasdaq Capital Market under the symbol BIAF, and its warrants to purchase common stock trade under the symbol BIAFW. SEC filings and company press releases state that bioAffinity has regained compliance with Nasdaq continued listing requirements, including the minimum bid price rule and an equity requirement, and that its securities continue to trade on the Nasdaq Capital Market.

The company has used SEC‑registered offerings and private placements, including registered direct financings and warrant‑related transactions, to raise capital for working capital needs and to support commercialization of CyPath® Lung and other corporate purposes. Registration statements on Form S‑1 and Form S‑3, as well as related amendments, describe the issuance of preferred stock, common stock and warrants, along with anti‑dilution provisions and resale registrations for certain warrant shares.

Business focus and growth themes

Across its public communications, bioAffinity consistently describes its mission as addressing an urgent unmet need for noninvasive early‑stage lung cancer diagnosis and diagnostics for other lung diseases. The company highlights:

• Development and commercialization of CyPath® Lung as a noninvasive, sputum‑based test for patients at high risk for lung cancer, including those with indeterminate pulmonary nodules.
• Use of advanced flow cytometry and AI‑driven algorithms to generate standardized, data‑driven diagnostic results from sputum samples.
• Case studies and clinical experience in which CyPath® Lung contributed to early Stage 1A lung cancer detection or helped avoid unnecessary invasive procedures.
• Expansion of intellectual property protecting both the diagnostic algorithm and the broader flow cytometry‑based platform for lung health assessment.
• Ongoing laboratory quality initiatives at PPLS, including CAP accreditation and CLIA certification, which the company associates with quality, accuracy and patient safety in its diagnostic services.

bioAffinity’s disclosures also reference work with health systems and government‑related providers, including the U.S. Department of Veterans Affairs (VA), where clinicians are incorporating CyPath® Lung into diagnostic pathways for patients with pulmonary nodules discovered incidentally or through recommended lung cancer screening.

Capital structure and warrants

SEC registration statements and current reports describe a capital structure that includes common stock, preferred stock and multiple series of warrants to purchase common stock. These documents outline:

• Series B Convertible Preferred Stock convertible into common stock.
• Common warrants issued in private placements and public offerings, with specified exercise prices, anti‑dilution adjustment provisions and floor price amendments.
• Placement agent and advisor warrants issued as partial compensation to financial intermediaries.

These filings explain that resale registration statements are intended to permit selling stockholders to resell shares underlying the warrants and preferred stock. The company notes that it will receive proceeds only upon cash exercise of the warrants, not from resale of the underlying shares by selling stockholders.

Use of financial and operating disclosures

bioAffinity’s quarterly and annual financial statements filed with the SEC provide detail on revenue from CyPath® Lung testing and from pathology services, operating expenses for research and development, clinical development and laboratory operations, and capital raised through equity transactions. Management commentary in earnings releases links financial trends—such as changes in revenue mix and operating costs—to strategic decisions like discontinuing certain pathology services and focusing resources on CyPath® Lung commercialization and clinical development.

Investors and analysts reviewing BIAFW, the company’s listed warrants, often consider these disclosures to understand the underlying business, the diagnostic technology, and the company’s approach to funding growth in noninvasive lung cancer diagnostics and related lung disease testing.