bioAffinity Technologies Boosts Data Acquisition for CyPath Lung Test

bioAffinity Technologies Inc. is enhancing the efficiency of its noninvasive lung cancer test (CyPath Lung) by decreasing the time required to acquire sample data for analysis by nearly half and reducing sample processing costs by about 60%.

These enhancements streamline lab processing and data acquisition workflows, reduce reagent usage, and cut laboratory supply costs—all without changing the test itself, the ways in which patient sputum samples are collected and processed, or the method by which data is acquired and analyzed. The improvements are expected to generate a greater than 10% increase in overall throughput and a unit cost decrease of more than 25%.

“The improvements we are announcing today are a result of a year-long operational analysis of how we could improve CyPath Lung without compromising the test’s high performance and without modification to the test that has been validated by our clinical trial,” bioAffinity Technologies President/CEO Maria Zannes said.

CyPath Lung uses flow cytometry and artificial intelligence to identify cell populations in patient sputum that indicate malignancy. Clinical study results demonstrated that CyPath Lung had a 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.

“Optimization of CyPath Lung is a key objective for our product development team. Alongside refining our branding, expanding our market and building sales, we evaluated operations to confirm to our shareholders that we are providing a cost-effective, accessible lung cancer diagnostic that meets a global need for earlier diagnosis to improve outcomes and increase patient survival while also reducing healthcare costs,” Zannes said.

Zannes highlighted a recent economic impact study, authored by pulmonologists Michael Morris, M.D., and Sheila Habib, M.D., that showed economic benefit for patients and the healthcare system if CyPath Lung is added to the current standard of care. The study 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. For privately insured patients, the savings could have reached an average of $6,460 per patient, or $895 million nationwide.

The study, “Economic Evaluation of a Novel Lung Cancer Diagnostic in a Population of Patients with a Positive Low-Dose Computed Tomography Result,” attributes the savings to a reduction in follow-up diagnostic assessments, expensive follow-up procedures and procedure-related complications. “The study by Dr. Morris and Dr. Habib reinforces the broader economic and clinical value of CyPath Lung within the healthcare landscape,” Zannes stated.

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 whether cancer is present. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival.

bioAffinity Technologies Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other lung diseases and broad-spectrum cancer treatments. The company’s first product, CyPath Lung, is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a bioAffinity Technologies subsidiary.