Physicians’ Case Studies Offer Insight into Use and Benefit of CyPath® Lung in Avoiding Unnecessary Invasive Procedures and Detecting Lung Cancer

Rhea-AI Summary

bioAffinity Technologies (NASDAQ: BIAF) has released physician case studies demonstrating the effectiveness of their CyPath® Lung noninvasive lung cancer detection test. A notable case study presented by Dr. Gordon H. Downie showed how the test helped avoid unnecessary invasive procedures for an 85-year-old high-risk patient.

The test's 'Unlikely Lung Cancer' result prevented risky biopsies, leading to a successful 'watchful waiting' approach where the patient's nodules resolved within three months. Dr. Downie, Director of the Pulmonary Nodule Clinic at Titus Regional Medical Center, has incorporated CyPath® Lung into his protocol for patients with indeterminate nodules.

A peer-reviewed economic impact study published in the Journal of Health Economics Outcomes and Research revealed significant potential cost savings: $2,773 per Medicare patient (total $379 million) and $6,460 per private-payer patient (total $895 million) if implemented as standard care for positive lung cancer screenings in 2022.

Positive

• Test successfully prevented unnecessary invasive procedures, reducing medical risks and costs
• Significant cost savings potential: $2,773 per Medicare patient ($379M total)
• Higher private insurance savings: $6,460 per patient ($895M total)
• Clinical validation through successful case studies showing real-world effectiveness

Negative

• None.

Insights

Financial & Healthcare Technology Analyst

bioAffinity Technologies has released compelling case studies demonstrating clear clinical utility for their CyPath® Lung diagnostic test, providing tangible evidence of both patient benefit and economic value.

The presented case study demonstrates how the test's "Unlikely Lung Cancer" result directly prevented unnecessary invasive procedures in an 85-year-old high-risk patient with suspected lung nodules. This real-world validation is significant as these nodules subsequently resolved within three months, confirming the test's accuracy in a high-stakes scenario where patient safety was directly improved.

The economic impact is particularly noteworthy. A peer-reviewed study shows potential average savings of $2,773 per Medicare patient ($379 million total) and $6,460 per private-payer patient ($895 million total). These figures represent substantial cost advantages that could drive adoption across healthcare systems seeking value-based care solutions.

For bioAffinity, this evidence strengthens their market positioning by demonstrating both clinical efficacy and economic value – the two critical factors that drive diagnostic test adoption. By reducing unnecessary procedures while maintaining diagnostic accuracy, CyPath® Lung addresses a significant pain point in the lung cancer diagnostic pathway.

The endorsement by Dr. Downie, who has incorporated the test into his clinical protocol, represents important physician validation that could accelerate adoption among other pulmonologists managing patients with indeterminate nodules.

SAN ANTONIO--(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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250313929796/en/

bioAffinity Technologies

Julie Anne Overton

Director of Communications

jao@bioaffinitytech.com

Investor Relations

Dave Gentry

RedChip Companies Inc.

1-800-RED-CHIP (733-2447) or 407-491-4498

BIAF@redchip.com

Source: bioAffinity Technologies, Inc.

FAQ

What cost savings does CyPath® Lung provide per Medicare patient according to the BIAF study?

The study shows CyPath® Lung could save $2,773 per Medicare patient, totaling $379 million if implemented as standard care for positive lung cancer screenings in 2022.

How much could private insurance patients save with BIAF's CyPath® Lung test?

Private-payer patients could save an average of $6,460 per patient, potentially totaling $895 million in savings if all screened individuals in 2022 were privately insured.

What clinical benefits were demonstrated in the BIAF case study for CyPath® Lung?

The test helped avoid unnecessary invasive procedures for an 85-year-old high-risk patient, leading to a successful 'watchful waiting' approach where nodules resolved within 3 months.

How does BIAF's CyPath® Lung test impact healthcare decision-making?

CyPath® Lung provides additional information for physicians and patients to make informed decisions about nodules less than 20mm, helping reduce anxiety and unnecessary invasive procedures.