SAN ANTONIO, March 13, 2025--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) announced the release of physicians’ case studies showing the benefit to patients and their doctors of using CyPath® Lung, the Company’s noninvasive test for early detection of lung cancer.
CyPath® Lung’s test result of "Unlikely Lung Cancer" directly prevented a robotic bronchoscopic biopsy or high-risk percutaneous biopsy in response to imaging that showed several new, small non-calcified pulmonary nodules for a high-risk 85-year-old patient with a greater than 20-pack-year smoking history, COPD and asbestos exposure. Based on the CyPath® Lung test result, the patient, who initially expressed a strong desire for more invasive procedures, agreed to "watchful waiting." In the intervening three months, all non-calcified nodules have resolved.
The case study was presented by Gordon H. Downie, MD, PhD, Director of the Pulmonary Nodule Clinic at Titus Regional Medical Center in Mount Pleasant, Texas, who has added CyPath® Lung to his protocol for patients with indeterminate nodules. "With nodules less than 20mm, the path forward is not always obvious. CyPath® Lung provides additional information that helps physicians and their patients make an informed decision," Dr. Downie said. "In this case, my patient is very proactive about his health and was ready to undergo an invasive procedure that carries real risk at his age. CyPath® Lung gave him the reassurance to opt for ongoing screening by low dose CT."
"The case study highlights how CyPath® Lung can reduce anxiety and unnecessary and risky invasive medical procedures, while at the same time increasing diagnostic accuracy," bioAffinity Technologies’ President and Chief Executive Officer Maria Zannes said. "The case study also illustrates why and how CyPath® Lung can lower healthcare costs to both the patient and America’s healthcare system, as detailed in the peer-reviewed study on the economic impact of CyPath® Lung published in the Journal of Health Economics Outcomes and Research."
The study, authored by pulmonologists Michael Morris, MD, and Sheila Habib, MD, 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, "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 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.
About CyPath® Lung 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. For more information, visit www.cypathlung.com.
About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding CyPath® Lung reducing anxiety and unnecessary and risky invasive medical procedures; increasing diagnostic accuracy; and CyPath® Lung lowering healthcare costs to both the patient and America’s healthcare system for an average cost savings of $2,773 per Medicare patient and an average of $6,460 per private-payer patient. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to reduce anxiety and unnecessary and risky invasive medical procedures, increase diagnostic accuracy, lower healthcare costs to both the patient and America’s healthcare system, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
