bioAffinity Technologies Reports Record Monthly CyPath® Lung Unit Sales and Significant Year-Over-Year Growth in April 2026

Key Terms

pulmonary nodules medical

Pulmonary nodules are small, round or oval spots found in the lungs on X-rays or CT scans; they can be scar tissue, infections, or early tumors. For investors, these findings matter because they can trigger diagnostic follow-up, treatment decisions, drug or device demand, clinical trial activity, regulatory scrutiny, and potential changes in healthcare costs or company valuations—think of a nodule like a small warning light that may or may not signal a serious engine problem.

biopsy medical

A biopsy is a medical procedure that removes a small piece of tissue or cells so a doctor can examine them under a microscope to see if disease, such as cancer or an infection, is present. For investors, biopsy results can change the outlook for drugs, diagnostics and medical devices—think of it like sampling a bite of food to decide whether the whole dish is safe; positive or negative findings can affect clinical trial success, approval chances, market demand and reimbursement decisions.

flow cytometry+AI medical

Flow cytometry + AI combines a laboratory technique that sorts and measures thousands of individual cells like a fast, automated scanner with artificial intelligence that reads the data to spot patterns and make predictions. For investors, this pairing can speed up diagnostics, improve drug development and reduce costly errors by turning complex cell measurements into actionable signals, much like having an expert quickly review thousands of documents and flag the most important ones.

longitudinal clinical study medical

A longitudinal clinical study tracks the same group of patients over months or years to observe how a treatment or disease progresses, rather than taking a one-time snapshot. For investors, these studies reveal long-term safety, effectiveness and durability of a therapy—information that helps assess regulatory risk, future sales potential and whether early positive results will hold up over time, much like watching a sapling grow into a full tree.

asthma medical

A chronic respiratory condition in which the airways become inflamed and narrow episodically, causing wheezing, coughing and shortness of breath; triggers can include allergens, exercise or infections. Think of it like a garden hose that suddenly kinks and restricts flow. Investors care because the size of the patient population and the effectiveness of treatments drive demand for drugs, devices and services, influence healthcare spending and can affect company revenues and stock performance.

copd medical

Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that progressively narrows airways and reduces the ability to breathe, causing persistent cough, shortness of breath and fatigue. It matters to investors because a large and growing patient population creates steady demand for drugs, medical devices and care services, influences healthcare spending and regulatory decisions, and offers clear market opportunities—similar to a leaking engine that requires ongoing fixes and replacement parts.

low-dose ct medical

Low-dose CT is a medical imaging scan that uses X-rays like a regular CT but reduces the radiation per scan so it’s closer to the dose of a strong X‑ray rather than a full CT. For investors, it matters because lower radiation makes routine screening programs (for example, lung screening) safer and more acceptable, which can increase demand for scanners, influence reimbursement and regulatory approval, and affect healthcare costs and device makers’ revenues.

CyPath® Lung unit sales in April increased nearly 300% compared to April 2025

Increasing unit sales for CyPath® Lung continues first quarter 2026 trend of accelerating adoption and clinical use

Noninvasive test has potential to transform lung cancer risk assessment and nodule management

SAN ANTONIO--(BUSINESS WIRE)-- bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced that unit sales for its CyPath® Lung diagnostic test achieved a record high in a single month and increased nearly 300% in April 2026 compared to the same period in 2025, based on preliminary unaudited data. The strong CyPath® Lung unit sales growth so far this year continues to exceed the Company’s internal projections and reflects accelerating physician adoption and expanding clinical use by physicians using the Company’s noninvasive test to aid in diagnosing lung cancer.

“The growth in CyPath® Lung usage continues to accelerate at a rapid pace as the value of our novel lung cancer diagnostic is increasingly being recognized,” said Maria Zannes, President and CEO of bioAffinity Technologies. “CyPath® Lung addresses a significant gap in the diagnostic pathway by supporting lung cancer risk stratification and pulmonary nodule management as physicians seek more accurate, noninvasive tools to assess cancer risk and detect disease at its earliest, most treatable stage. We are very pleased with the unit growth that we delivered in April, and we remain focused on expanding adoption of CyPath® Lung to aid physicians in the early detection of lung cancer and pulmonary nodule management.”

Addressing a Large and Growing Clinical Need

The number of patients identified with indeterminate pulmonary nodules continues to rise, driven in part by increases in incidental findings and screening by low-dose CT for high-risk patients. This expanding patient population poses a diagnostic challenge for physicians who have to weigh the benefits and risks of “watchful waiting” versus invasive procedures like biopsy.

CyPath® Lung’s flow cytometry+AI technology provides actionable information to support clinical decision-making by the ordering physician. The test result is intended to be used in conjunction with other clinical information and is not a standalone diagnostic. Real-world patient cases have demonstrated the test’s ability to:

• Help detect lung cancer at Stage 1A, when it is most treatable
• Help avoid unnecessary invasive, risky, and costly procedures when the test result is negative

Executing a Focused Commercial Strategy

bioAffinity Technologies has prioritized CyPath® Lung as its core commercial focus, aligning resources to accelerate adoption and scale. Growth has been driven by:

• Expansion of ordering physician sites
• Increased peer-to-peer education among pulmonologists
• Integration of CyPath® Lung into clinical workflows for lung cancer risk assessment and nodule management

Positioned for Continued Expansion

The company is advancing multiple initiatives to further expand the clinical impact of its proprietary technology platform, including:

• A large-scale longitudinal clinical study designed to generate additional validation data for CyPath® Lung
• Broader use of CyPath® Lung to monitor lung cancer survivors after treatment
• An R&D pipeline that includes diagnostic tests for asthma and COPD that will help guide personalized treatment with targeted therapies.

About CyPath® Lung

CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

About bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to maintain and grow CyPath® Lung unit volume, the Company's ability to achieve or maintain profitability, the Company's dependence on a single commercial product, risks related to the regulatory environment for laboratory developed tests, the Company's ability to obtain adequate reimbursement coverage for CyPath® Lung, the Company's ability to successfully execute its commercial strategy and expand its customer base, the outcome of ongoing and future clinical studies, and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260512770887/en/

bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com

Source: bioAffinity Technologies, Inc.