bioAffinity Technologies has released compelling real-world clinical evidence demonstrating the diagnostic impact of CyPath® Lung, a noninvasive sputum-based test for early-stage lung cancer detection. The evidence comes through a white paper authored by Dr. Gordon Downie, MD, PhD, Director of the Lung Nodule Clinic and Interventional Pulmonology at Titus Regional Medical Center, and a detailed case study showing the test's ability to detect second primary lung cancers.
Clinical Evidence from Real-World Practice
Dr. Downie's white paper, titled "CyPath® Lung in Practice: Cases 1-4," presents four clinical cases where the test significantly influenced decision-making for patients with indeterminate pulmonary nodules. The cases involved high-risk patients with complex clinical presentations, including sub-8 mm nodules in hard-to-biopsy locations, patients with prior cancer history complicating imaging interpretation, and those with post-COVID pulmonary changes.
"Over the past year, CyPath® Lung has become an active component in our clinical assessment of newly discovered non-calcified pulmonary nodules. It has accelerated diagnosis, helped guide difficult clinical discussions, and prevented unnecessary invasive procedures," Dr. Downie stated.
The diagnostic challenge is significant, as Dr. Downie noted: "As more high-risk patients are screened, we are seeing an explosion in lung nodules, 98% of which we know are benign. But we don't want to miss that remaining 2%."
Detection of Second Primary Lung Cancer
A particularly compelling case study involved a 72-year-old patient with a 50 pack-year smoking history and significant COPD who had previously undergone wedge resection for stage 1A non-small cell lung cancer in 2023. During routine surveillance, CT scans revealed changes in scar tissue, raising concerns about potential recurrence.
"Subtle changes post-op are common and present a diagnostic dilemma. Due to her previous cancer diagnosis, serum markers were contra-indicated, and a PET scan may be inconclusive on smaller nodules," Dr. Downie explained. "But now we have CyPath® Lung. Her CyPath® result came back as likely cancer, which told me in real time that there were new malignant cells in her lungs."
The positive CyPath® result prompted Dr. Downie to order a PET scan that revealed significant avidity in the mediastinum and right hilum, along with a new nodule in the right upper lung. Subsequent bronchoscopy confirmed a diagnosis of small cell carcinoma, distinct from the initial non-small cell lung cancer, enabling timely treatment for the second primary cancer.
Technology and Performance Metrics
CyPath® Lung employs proprietary advanced flow cytometry and artificial intelligence to identify cell populations in patient sputum that indicate malignancy. The test incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells, with automated data analysis determining cancer presence.
Clinical study results demonstrated that CyPath® Lung achieved 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters.
Economic Impact Analysis
A study published in the Journal of Health Economics Outcomes and Research, authored by pulmonologists Michael Morris, MD, and Sheila Habib, MD, analyzed the potential cost savings of integrating CyPath® Lung into standard care. The analysis found that an average cost savings of $2,773 per patient would have been achieved in 2022 if CyPath® Lung had been part of standard care for Medicare patients with positive lung cancer screening, totaling $379 million.
For private-payer patients, the potential savings were even greater, with an average of $6,460 per patient, representing an estimated total savings of $895 million if all individuals screened in 2022 were covered by private insurance. The study attributes these savings to reduced follow-up diagnostic assessments, expensive follow-up procedures, and procedure-related complications.
Clinical Integration and Future Implications
According to Maria Zannes, President and CEO of bioAffinity Technologies, "Dr. Downie's clinical insights and impactful white paper confirm the value of adding CyPath® Lung to the standard of care for physicians navigating the complexities of pulmonary nodules in high-risk patients."
The test is currently marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. The clinical evidence suggests that CyPath® Lung provides actionable information that enables physicians to make more informed decisions about whether to continue monitoring nodules or proceed with further evaluation, including biopsy.
Dr. Downie emphasized the test's role in clinical decision-making: "Adding CyPath® Lung as an adjuvant after imaging by low dose CT and PET provides real-time information about the likelihood of malignancy. Now my patients and I can make a more informed decision about whether to continue to monitor the nodules or proceed with further evaluation, including biopsy."
