bioAffinity Technologies Reports More Than 200% Growth in CyPath® Lung Sales as Physician Adoption Continues to Accelerate
bioAffinity Technologies, Inc., a biotechnology company dedicated to developing innovative, noninvasive diagnostic solutions for lung cancer and other pulmonary diseases, has announced strong commercial momentum for its flagship diagnostic test, CyPath® Lung, reporting year-over-year sales growth of more than 200% during the second quarter of 2026.
The company also reported sequential growth of more than 30% compared with the first quarter of 2026, reflecting increasing physician adoption and expanding clinical utilization of the noninvasive lung cancer diagnostic. The latest performance underscores growing confidence among healthcare providers in CyPath® Lung as an additional decision-support tool for evaluating patients with indeterminate pulmonary nodules—an increasingly common clinical challenge as lung cancer screening programs continue to expand.
According to bioAffinity Technologies, nearly 3,000 CyPath® Lung tests have now been performed since the product’s commercial launch, highlighting steady progress in market adoption across pulmonology practices, lung nodule clinics, academic medical centers, community hospitals, and Veterans Affairs (VA) healthcare facilities.
Growing Adoption Reflects Changing Clinical Practice
The company believes the continued acceleration in CyPath® Lung utilization reflects a broader shift in clinical practice as physicians become more familiar with the test and accumulate firsthand experience with its performance.
Rather than relying solely on new customer acquisition, bioAffinity Technologies noted that existing physicians are increasingly incorporating the test into routine patient management, suggesting sustained confidence in its clinical value.
Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies, emphasized that repeat ordering patterns have become one of the strongest indicators of the product’s growing acceptance within the pulmonary care community.
According to Zannes, physicians who begin using CyPath® Lung frequently continue ordering the test because they recognize its ability to complement imaging studies and assist in making more informed clinical decisions.
The company believes this repeat utilization demonstrates that CyPath® Lung is evolving from an optional adjunct diagnostic into a regular component of patient evaluation for pulmonary nodules.
Addressing a Critical Challenge in Lung Cancer Diagnosis
Indeterminate pulmonary nodules represent one of the most common and challenging findings in modern pulmonary medicine.
These small lung abnormalities are increasingly detected through low-dose CT lung cancer screening programs as well as imaging performed for unrelated medical conditions.
Although many pulmonary nodules are ultimately found to be benign, distinguishing harmless lesions from early-stage lung cancer remains difficult.
As a result, physicians often face complex decisions regarding whether patients require invasive diagnostic procedures, surgical biopsies, or continued imaging surveillance.
Current evaluation strategies typically incorporate imaging characteristics, patient history, smoking exposure, and established clinical risk models.
However, uncertainty frequently remains, particularly when imaging findings fall into intermediate-risk categories.
CyPath® Lung was developed to provide clinicians with an additional noninvasive source of objective biological information that may improve confidence during this decision-making process.
Supporting Earlier Lung Cancer Detection
Early detection remains one of the most important factors influencing survival outcomes in lung cancer.
When diagnosed at Stage I, lung cancer is often treatable with surgery or localized therapies offering significantly higher long-term survival rates than disease detected after metastasis.
bioAffinity Technologies noted that published patient case studies have demonstrated situations in which CyPath® Lung identified lung cancer at Stage 1A, despite conventional risk assessment tools and other adjunctive tests suggesting relatively low risk.
These findings illustrate the potential value of adding biological information alongside imaging during evaluation of suspicious pulmonary nodules.
Earlier identification of malignancy may enable physicians to initiate curative treatment sooner while improving long-term patient outcomes.
Although larger clinical studies continue, these early reports contribute to growing physician confidence in the technology.
Helping Reduce Unnecessary Procedures
The benefits of improved diagnostic accuracy extend beyond identifying cancer earlier.
Many patients undergoing evaluation for pulmonary nodules have additional medical conditions that increase the risks associated with invasive diagnostic procedures such as bronchoscopy, needle biopsy, or lung surgery.
According to the company, negative CyPath® Lung results have helped some patients avoid unnecessary invasive interventions when clinical circumstances supported continued monitoring instead.
Reducing unnecessary procedures may lessen procedural complications, healthcare costs, patient anxiety, and hospitalization while preserving appropriate surveillance strategies.
For elderly patients or those with significant cardiopulmonary disease, avoiding unnecessary invasive testing can be particularly meaningful.
Patient Experience Highlights Emotional Impact
bioAffinity Technologies also shared insights into the emotional burden experienced by patients diagnosed with pulmonary nodules.
Receiving news of a suspicious lung abnormality often creates significant anxiety while patients wait for additional testing or biopsy results.
One patient featured in a recent interview described the fear she experienced after learning about her pulmonary nodule.
She recalled feeling terrified and deeply grateful to have access to a diagnostic option that did not require an invasive procedure.
The company believes patient experiences like these illustrate the broader value of developing accurate, minimally invasive diagnostics that reduce both physical risk and psychological stress during cancer evaluation.
Commercial Strategy Focuses on Sustainable Growth
To build upon current momentum, bioAffinity Technologies continues executing a multi-pronged commercial strategy designed to expand physician awareness and increase utilization among existing customers.
Key priorities include strengthening relationships with pulmonologists, expanding commercial activities within established geographic markets, selectively entering new healthcare regions, and increasing adoption across both academic and community-based healthcare systems.
Rather than focusing solely on acquiring new clinical sites, the company is emphasizing deeper integration within existing practices, encouraging physicians to routinely incorporate CyPath® Lung into pulmonary nodule management workflows.
This strategy aims to generate sustained long-term growth through repeat utilization while broadening overall market penetration.
Lung Cancer Screening Expected to Increase Demand
The company believes demand for pulmonary nodule diagnostics will continue growing over the coming years.
Expanded implementation of lung cancer screening programs has significantly increased the number of individuals undergoing low-dose CT imaging, particularly among current and former smokers considered at elevated risk for lung cancer.
At the same time, improvements in medical imaging across numerous specialties continue to generate incidental detection of pulmonary nodules during scans performed for unrelated conditions.
As screening expands, physicians are expected to encounter increasing numbers of patients requiring careful evaluation to determine whether nodules represent benign abnormalities or early malignancy.
This growing patient population reinforces the need for additional diagnostic tools capable of supporting individualized clinical decision-making.
Clinical Perspective on Diagnostic Needs
Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies, emphasized the importance of objective diagnostic tools in managing this expanding clinical challenge.
According to Downie, physicians must balance the need for timely cancer diagnosis against the risks associated with unnecessary invasive procedures.
CyPath® Lung was specifically developed to complement existing imaging approaches by providing clinicians with additional objective information during patient evaluation.
The company believes this integrated approach may improve risk assessment while helping physicians determine which patients require immediate intervention and which can safely undergo continued surveillance.
Expanding the Clinical Utility of CyPath® Lung
Beyond its current commercial applications, bioAffinity Technologies is pursuing several initiatives designed to further expand the clinical utility of its proprietary diagnostic platform.
One major effort involves conducting a large-scale longitudinal clinical study intended to generate additional validation data supporting CyPath® Lung.
Such evidence could further strengthen physician confidence while supporting broader adoption across healthcare systems.
The company is also investigating the potential use of CyPath® Lung in monitoring patients following lung cancer treatment.
Cancer survivors often require long-term surveillance to detect recurrence as early as possible.
bioAffinity believes its diagnostic technology may eventually play an important role in post-treatment monitoring by providing clinicians with additional biological information alongside routine imaging.
Building a Broader Pulmonary Diagnostics Pipeline
CyPath® Lung represents only the first application of bioAffinity Technologies’ automated flow cytometry platform.
The company is leveraging the same underlying technology to develop additional noninvasive diagnostic tests targeting other chronic pulmonary diseases.
Current research and development programs include tests designed for asthma and chronic obstructive pulmonary disease (COPD).
Unlike traditional approaches focused primarily on symptom management, these future diagnostics aim to help physicians identify disease subtypes and match patients with the therapies most likely to benefit them.
As precision medicine continues expanding within respiratory care, such personalized diagnostic approaches may improve treatment selection while reducing ineffective therapies.
Automated Flow Cytometry Platform Supports Future Innovation
According to Dr. Downie, the company’s automated flow cytometry platform provides the technological foundation for an expanding portfolio of lung disease diagnostics.
By analyzing cellular characteristics from noninvasive samples, the platform is intended to generate objective biological insights applicable across multiple respiratory diseases.
The company believes continued development of this technology could support a growing family of diagnostic products addressing diverse pulmonary conditions affecting millions of patients worldwide.
This broader vision extends beyond lung cancer detection to encompass personalized disease management across respiratory medicine.
With commercial sales continuing to accelerate and physician adoption steadily expanding, bioAffinity Technologies believes CyPath® Lung is gaining traction as an important noninvasive diagnostic tool in pulmonary medicine. The combination of strong repeat utilization, expanding clinical evidence, and growing demand driven by increased lung cancer screening positions the company for continued commercial growth.
At the same time, ongoing clinical validation studies, oncology surveillance initiatives, and the expansion of its respiratory diagnostics pipeline reflect a long-term strategy aimed at transforming how lung diseases are diagnosed and managed. As the company continues advancing both commercial execution and research efforts, it remains focused on improving early disease detection, reducing unnecessary invasive procedures, and enabling more personalized care for patients with lung cancer, asthma, COPD, and other pulmonary disorders.
bioAffinity Technologies expects to report its financial results for the second quarter of 2026 in August, providing additional insight into the company’s commercial progress and operational performance.
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 published 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), which are administered by the Centers for Medicare & Medicaid Services.