June 9, 2025 — bioAffinity Technologies, Inc., a biotechnology company addressing the need for noninvasive, accurate tests for the detection of early-stage cancer, has released a new case study of a complex clinical case in which CyPath Lung identified Stage 1A adenocarcinoma lung cancer in a patient whose PET imaging and risk model probability indicated a low risk of malignancy.
“CyPath Lung gave us the critical data point we were missing. This patient had all the red flags – heavy tobacco use, COPD and a suspicious nodule – but imaging and risk calculators weren’t enough for the patient to overcome her trepidation and to justify an invasive procedure. The CyPath Lung test result tipped the scale. Without it, we might have waited for the next annual CT scan, and we could have missed a Stage 1A lung cancer,” said Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer. “Instead, CyPath Lung gave us the confidence to intervene surgically when everything else pointed in the direction of watchful waiting.”
The patient, a 70-year-old female, was an active smoker with more than a 50 pack-year history and COPD. In April 2023, a low-dose CT scan revealed nodules in the right upper and middle lobes. A follow-up scan in December of that year showed improvement, including resolution of the 5 mm nodule in the right upper lobe. But the December scan also revealed a new 3 mm nodule in the fissure between the two lobes. Risk calculators placed the probability of malignancy at only 0.2%, and clinical guidelines recommended annual CT surveillance.
By February 2025, the fissure nodule had grown to 8 mm, but a PET scan showed low uptake of the radioactive tracer, which is consistent with a benign outcome. Dr. Downie, who at the time was the Director of the Lung Nodule Clinic at Titus Regional Medical Center, ordered CyPath Lung for his patient. The test returned a positive result of 0.83, indicating a high probability of lung cancer. The patient subsequently quit smoking and underwent surgery to remove the nodule via wedge resection. Pathology confirmed Stage 1A adenocarcinoma.
“Each case study underscores the benefit of adding CyPath Lung to the standard of care for evaluating indeterminate lung nodules,” bioAffinity Technologies’ President and CEO Maria Zannes said. “CyPath Lung provides clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated or simply fall short.”
CyPath Lung is reimbursed by Medicare and commercial payers and is available through the Federal Supply Schedule for veterans and active-duty military.
A peer-reviewed study authored by Michael Morris, MD, at Brooke Army Medical Center and Sheila Habib, MD, Director of the Pulmonary Lung Nodule Clinic and Lung Cancer Screening Program at the Audie L. Murphy Memorial VA Hospital, estimated that use of CyPath Lung with patients who had small pulmonary nodules in 2022 could have saved $2,733 per Medicare patient for total savings of $370 million. The savings jump to an average of $6,460 per patient if all individuals screened in 2022 were covered by private insurance.
For more information, visit www.bioaffinitytech.com.
July 14, 2025 
