On September 1, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, reported that it is advancing the potential application of its CyPath Lung test for surveillance of lung cancer patients who have completed curative-intent treatment.
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Lung cancer recurrence remains a significant clinical challenge. According to the American Cancer Society, there were more than 680,000 Americans living with a prior lung cancer diagnosis as of January 1, 2025.1 The National Cancer Institute estimates that another 230,000 patients will be diagnosed with lung cancer in 2026.
"For patients who have completed cancer treatment, the discovery of a new pulmonary nodule can create tremendous uncertainty. Imaging alone cannot tell us if it is recurrent cancer, a new cancer, or benign post-treatment changes including fibrosis, scarring, and treatment-related inflammation," said Vijay Gunuganti, MD, an oncologist with Texas Oncology, a physician-led practice in San Antonio, Texas. "CyPath Lung can provide additional information without immediately subjecting the patient to an invasive procedure. The test’s binary result – unlikely or likely malignancy – can help us determine which patients need closer investigation and which patients may be appropriate for continued surveillance."
"CyPath Lung has demonstrated its ability to detect early-stage lung cancer in clinical trials and clinical practice," said Maria Zannes, President and CEO of bioAffinity Technologies. "As our commercial experience with CyPath Lung grows, we are examining how our noninvasive approach may provide value throughout the patient’s lung cancer journey. We believe surveillance after cancer treatment has the potential to lead to earlier intervention and could be an important complement to early detection for newly diagnosed patients in terms of improving patient outcomes."
Even when patients have no evidence of disease (NED) following surgery or radiation, published studies report recurrence rates of approximately 20% to 55% for non-small cell lung cancer (NSCLC), depending on stage, treatment and other factors.2 The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) recommends surveillance imaging every six months for two years following curative-intent treatment of stage I–III NSCLC, followed by annual low-dose CT to monitor for new primary lung cancers.3
"Finishing curative-intent treatment is not the end of cancer care. As survival rates continue to improve and more people with a cancer diagnosis are living longer lives, survivorship care is increasingly important. That means proactive follow-up for recurrence, screening for new cancers and monitoring for long-term treatment effects," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies." CyPath Lung complements CT surveillance by providing actionable information that helps physicians evaluate new or changing pulmonary nodules identified by imaging."
The potential role of CyPath Lung in recurrence surveillance builds on the test’s ability to analyze the lung microenvironment in real time. Drawing on three years of commercial experience, CyPath Lung has shown promising clinical performance in helping physicians stratify malignancy risk and guide patient management, including clinical case studies that illustrate how CyPath Lung helped clarify challenging cases in which imaging findings and predictive models alone produced uncertain or conflicting assessments.
(Press release, BioAffinity Technologies, SEP 1, 2026, View Source [SID1234670479])