bioAffinity Technologies Publishes Clinical Framework for CyPath® Lung in Pulmonary Nodule Evaluation and Early Lung Cancer Detection
bioAffinity Technologies, a biotechnology company focused on noninvasive diagnostics and early cancer detection, has announced the publication of a comprehensive clinical review and white paper examining how CyPath® Lung can be incorporated into the evaluation of pulmonary nodules and the long-term surveillance of patients at risk for lung cancer.
The publication, titled “Lung Nodules, Lung Microenvironment, Predictive Models and Clinician Risk Stratification Using CyPath® Lung Testing for Early Diagnosis of Lung Cancer,” was authored by Gordon H. Downie, MD, PhD, chief medical officer of bioAffinity Technologies. The paper presents a practical clinical framework for using CyPath® Lung as an additional tool in the assessment of patients with pulmonary nodules and other clinical situations where physicians must determine the likelihood of malignancy.
The publication comes as the healthcare system faces a growing number of pulmonary nodules requiring evaluation. The expansion of lung cancer screening programs, the increasing use of advanced imaging technologies, the rise in incidental findings, and the growing use of artificial intelligence in radiology are all contributing to the identification of more lung nodules.
At the same time, patients who have previously been treated for cancer may require extended surveillance because of the risk of recurrence or the development of new malignancies. As the number of patients requiring follow-up increases, clinicians need reliable tools that can help distinguish nodules requiring further invasive investigation from those that may be safely monitored.
Growing Need for Better Pulmonary Nodule Risk Stratification
Pulmonary nodules are common findings in clinical practice. Many are benign, but some may represent early-stage lung cancer. Determining which nodules require biopsy or other invasive procedures can be challenging because physicians must consider multiple factors, including nodule size, appearance, growth rate, patient age, smoking history, previous cancer history, and other clinical characteristics.
Imaging is central to pulmonary nodule evaluation, but imaging findings may not always provide a definitive answer. Some nodules have characteristics that make it difficult to determine whether they are malignant or benign. In these cases, clinicians may need to rely on a combination of imaging, predictive models, clinical experience, and additional testing.
The expansion of lung cancer screening has increased the importance of this challenge. As more individuals undergo screening, the number of abnormalities requiring follow-up is expected to grow. In addition, improved imaging technologies are capable of identifying increasingly small or subtle lesions that may previously have gone undetected.
Artificial intelligence is also being used to analyze medical images and identify potential abnormalities. While AI may improve detection capabilities, increased detection can also result in more incidental findings requiring clinical evaluation.
bioAffinity believes these developments are creating a need for complementary diagnostic technologies that can help clinicians improve the risk stratification process.
“Pulmonary medicine is entering a new era in which clinicians are evaluating more pulmonary nodules than ever before, driving a rapidly growing need for better risk stratification,” said Maria Zannes, president and chief executive officer of bioAffinity Technologies.
According to Zannes, the company’s white paper describes how CyPath® Lung can provide physicians with additional clinically meaningful information that complements imaging and clinical assessment. The objective is to help physicians make more informed decisions about which patients may require invasive procedures and which patients may be appropriate for continued monitoring.
CyPath® Lung Provides Noninvasive Assessment
CyPath® Lung is a noninvasive diagnostic test designed to assist in the evaluation of lung cancer risk. The test analyzes sputum collected from the lungs, allowing it to examine biological information from the pulmonary microenvironment.
This approach differs from blood-based testing, which analyzes biomarkers circulating throughout the body. According to bioAffinity, the lung microenvironment can provide information that may be directly relevant to biological processes occurring in the lungs.
The company’s technology uses porphyrin-labeled malignant cells, proprietary flow cytometry, and artificial intelligence analysis to identify biological changes associated with cancer.
The white paper examines how this approach may provide clinicians with additional information in cases where imaging and existing predictive models produce uncertain or conflicting assessments.
Rather than positioning CyPath® Lung as a replacement for imaging, clinical guidelines, or physician judgment, the framework presents the test as a complementary tool. The goal is to provide clinicians with another source of information when evaluating the overall risk of malignancy.
Clinical Experience from Commercial Use
The publication draws on three years of commercial experience since CyPath® Lung entered the market. According to bioAffinity, this experience has provided insight into how the test can be used in real-world clinical settings.
The paper discusses the test’s reported performance in helping physicians stratify malignancy risk and support patient management decisions. It also includes clinical case studies illustrating situations in which CyPath® Lung helped clarify challenging clinical presentations.
In some cases, physicians may encounter a patient whose imaging results suggest an elevated risk of cancer, while predictive models or other clinical factors indicate a different level of concern. Such conflicting information can complicate decisions about whether to proceed with invasive procedures or continue surveillance.
The white paper suggests that CyPath® Lung may provide an additional biological data point in these situations.
The company emphasizes that every patient requires individualized assessment. A diagnostic test is one component of a broader clinical decision-making process, and physicians must consider the full range of available information before determining the appropriate next step.
Focus on the Lung Microenvironment
A central theme of the white paper is the importance of the lung microenvironment in understanding disease.
The lung has a biological environment that is distinct from the bloodstream. Local immune responses, inflammatory activity, genetic changes, and tumor biology may all contribute to changes within the lung microenvironment.
Traditional diagnostic approaches may not always capture the full range of these local biological processes. Blood-based testing, for example, may detect signals that are diluted or influenced by processes occurring throughout the body.
CyPath® Lung is designed to analyze sputum obtained directly from the lungs. According to bioAffinity, this approach allows the test to evaluate biological information from the area where the disease process may be occurring.
The company believes that analyzing the lung microenvironment could provide useful information for patients with complex or ambiguous clinical presentations.
The test uses proprietary technology to identify porphyrin-labeled malignant cells. These cells are then analyzed using flow cytometry and artificial intelligence-based methods.
By combining biological analysis with computational tools, the platform is intended to provide objective information that can support the clinician’s assessment of pulmonary nodule risk.
Three Proposed Clinical Pathways
The white paper proposes specialty-specific clinical pathways for incorporating CyPath® Lung into different care settings.
The first setting is primary care, where physicians may encounter patients with incidentally discovered pulmonary nodules. Primary care clinicians are often responsible for coordinating follow-up after an abnormal imaging finding. Additional risk information may help determine whether a patient should be referred for specialist evaluation or monitored through an established surveillance pathway.
The second setting is pulmonary nodule programs and interventional pulmonology practices. These specialists frequently evaluate patients who may require biopsy or other invasive procedures. In this setting, CyPath® Lung could serve as an additional source of information when clinicians are assessing the potential malignancy of a pulmonary nodule.
The third setting is oncology, particularly the surveillance of cancer survivors. Patients who have previously been treated for cancer may require ongoing monitoring for recurrence or new disease. Pulmonary findings in these patients can be especially challenging to interpret because abnormalities may reflect recurrence, a new primary cancer, infection, inflammation, or other causes.
The framework described in the white paper is intended to help clinicians integrate CyPath® Lung with existing clinical practices rather than replace established guidelines.
Supporting Clinical Decision-Making
Dr. Downie emphasized that the purpose of the framework is not to replace physician judgment or established clinical recommendations.
“Every patient presents a unique clinical picture,” Dr. Downie said. “The objective is not to replace clinician gestalt or existing guidelines, but to provide an additional data point when clinical findings are uncertain or contradictory.”
According to Dr. Downie, the ability of CyPath® Lung to interrogate the lung microenvironment provides information that may not be available through traditional imaging or blood-based testing.
This approach reflects a broader trend in modern diagnostics toward the integration of multiple data sources. Imaging, clinical history, laboratory testing, molecular diagnostics, and artificial intelligence are increasingly being used together to provide a more comprehensive view of disease risk.
For pulmonary nodule evaluation, this type of integrated approach may be particularly valuable because no single diagnostic method is capable of providing a complete answer in every patient.
Potential Role in Early Lung Cancer Detection
Early detection remains an important goal in lung cancer care. When lung cancer is identified at an earlier stage, patients may have more treatment options and potentially better outcomes.
However, early-stage disease can be difficult to identify because small pulmonary nodules may be difficult to classify. Some malignant nodules may have subtle imaging characteristics, while benign nodules can sometimes appear suspicious.
As lung cancer screening expands, clinicians will increasingly need tools that can help manage the growing number of findings generated by screening programs.
bioAffinity’s clinical framework focuses on the potential role of CyPath® Lung in this evolving environment. The company believes that the test may help support more informed risk stratification by providing biological information from the lung microenvironment.
The approach could potentially help clinicians determine which patients require additional evaluation and which may be candidates for surveillance.
Addressing the Challenges of Invasive Procedures
One of the major challenges in pulmonary nodule management is balancing the need for early cancer detection with the risks associated with invasive procedures.
A biopsy can provide important diagnostic information, but invasive procedures may carry risks and may not always be necessary for patients whose nodules are ultimately determined to be benign.
Improved risk stratification could help physicians make more informed decisions about when invasive testing is appropriate.
The company’s framework presents CyPath® Lung as a potential tool for supporting these decisions. By adding biological information to existing imaging and clinical data, the test may help clinicians develop a more comprehensive understanding of a patient’s risk profile.
However, the decision to biopsy or monitor a nodule remains a clinical judgment based on the patient’s complete medical situation.
Looking Ahead for Noninvasive Diagnostics
The publication of the white paper highlights bioAffinity Technologies’ continued focus on noninvasive diagnostics and early cancer detection.
As healthcare moves toward more personalized approaches to disease management, diagnostic tools capable of providing additional biological information may become increasingly important.
The company believes that the lung microenvironment represents an underused source of information in the evaluation of pulmonary disease. Through CyPath® Lung, bioAffinity is seeking to develop a diagnostic approach that provides clinicians with objective information directly from the lungs.
The company’s experience with the test over the past three years has also allowed it to gather insights from commercial use and clinical applications. These insights form part of the foundation for the clinical framework outlined in the new publication.
The white paper provides a roadmap for the potential integration of CyPath® Lung across primary care, pulmonary medicine, interventional pulmonology, and oncology.
As the number of pulmonary nodules identified through screening and advanced imaging continues to rise, the need for effective risk stratification tools is likely to grow. Clinicians will increasingly need to determine which patients require immediate invasive evaluation and which can be safely followed over time.
bioAffinity Technologies believes CyPath® Lung could play a role in this decision-making process by complementing imaging, predictive models, clinical guidelines, and physician expertise.
Through its focus on the lung microenvironment, noninvasive testing, and artificial intelligence-enabled analysis, the company is seeking to advance a more comprehensive approach to early lung cancer detection.
The latest clinical framework represents another step in that effort, highlighting the potential of CyPath® Lung to provide additional information in challenging pulmonary nodule cases and support more informed clinical decisions across multiple areas of patient care.
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