CyPath Lung Helped Detect Breast Cancer Recurrence

bioAffinity Technologies Inc. has released a study of a complex clinical case in which CyPath Lung’s real-time assessment of the lung microenvironment identified a hidden recurrence of breast cancer in an 80-year-old high-risk patient.

“This case exemplifies how CyPath Lung can play a crucial role not only in lung cancer diagnostics but also in broader oncological decision-making, helping to guide clinical strategies and improve patient outcomes while reducing risky invasive procedures,” bioAffinity Technologies’ President/CEO Maria Zannes said.

The patient, a former smoker with COPD who was treated successfully for breast cancer in 2019, was under surveillance for lung cancer due to her history. A routine low-dose computed tomography (CT) scan detected indeterminate nodules, including an 8 mm non-calcified nodule in her left upper lung lobe.

“Given her risk factors and the fact that I’ve been following her with CT scans, this finding was very worrisome,” stated Gordon H. Downie, M.D., Ph.D., director of the Pulmonary Nodule Clinic at Titus Regional Medical Center in Mount Pleasant, Texas.

Traditional diagnostic approaches presented challenges. A PET scan was unlikely to provide clarity due to the lesion’s small size, and serum markers were contraindicated because of her prior cancer. “The CyPath Lung test afforded me the ability in real time to assess a small nodule in a high-risk patient,” Dr. Downie said. “The result was likely malignant which launched an aggressive, forward-looking diagnostic approach.”

Recognizing the patient’s history, her care team conducted a follow-up mammogram, which revealed a new breast cancer confirmed by biopsy.

“Each case study underscores the benefit of adding CyPath Lung to the standard of care for evaluating indeterminate lung nodules,” Zannes remarked. “By providing earlier and more accurate diagnostic insights, CyPath Lung can help reduce the need for costly, invasive follow-up procedures, ultimately lowering healthcare costs while improving patient outcomes. This growing body of evidence strengthens the case for broader adoption of CyPath Lung, highlighting the significant financial and clinical benefits of our technology.”

A study published in the Journal of Health Economics Outcomes and Research and authored by pulmonologists Michael Morris, M.D., and Sheila Habib, M.D., found that an average cost savings of $2,773 per patient would have been achieved in 2022 if CyPath Lung had been part of the standard of care for Medicare patients with a positive lung cancer screening, for a total of $379 million. The study attributes the savings to a reduction in follow-up diagnostic assessments, expensive follow-up procedures and procedure-related complications. The study also found that adding CyPath Lung to the standard of care for private-payer patients with a positive lung cancer screening result could have saved even more, an average of $6,460 per patient, an estimated total savings of $895 million if all individuals screened in 2022 were covered by private insurance.

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 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. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival.

bioAffinity Technologies Inc. addresses the need for noninvasively diagnosing early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a bioAffinity Technologies subsidiary.