bioAffinity Technologies’ noninvasive sputum test revealed early-stage lung cancer when other diagnostic options were contraindicated

bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive, accurate tests for the detection of early-stage cancer, today 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 5mm nodule in the right upper lobe. But the December scan also revealed a new 3mm 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 8mm, 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.

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 the ability of CyPath^® Lung to indicate a high probability of lung cancer, the benefits of adding CyPath® Lung to the standard of care for evaluating indeterminate lung nodules, CyPath® Lung providing clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated, the savings that may result from the use of CyPath® Lung with patients who had small pulmonary nodules, and the ability of CyPath® Lung to determine if cancer is present or if the patient is cancer-free. 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 indicate a high probability of lung cancer, CyPath® Lung providing clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated, the ability of CyPath® Lung to determine if cancer is present or if the patient is cancer-free and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250709031359/en/

"This patient had all the red flags – heavy tobacco use, COPD and a suspicious nodule – but imaging and risk calculators weren’t enough ... to justify an invasive procedure. The CyPath® Lung test result tipped the scale."