bioAffinity's Test Targets Costly Uncertainty in Lung Cancer Screening

SAN ANTONIO, TX – December 03, 2025 – In the world of biotechnology, a poster presentation at a medical conference is rarely the catalyst for a fundamental market shift. Yet, as bioAffinity Technologies (Nasdaq: BIAF) prepares to showcase its CyPath® Lung test at the American Cancer Society National Lung Cancer Roundtable, the event signifies more than just scientific validation. It represents a critical inflection point for a company aiming to solve one of modern medicine’s most expensive and anxiety-inducing dilemmas: the indeterminate pulmonary nodule.

For years, the financial and clinical landscapes have been burdened by the ambiguity that follows a low-dose CT (LDCT) scan. A small spot on the lungs can trigger a cascade of events, thrusting patients into a “diagnostic odyssey” of repeated scans, invasive procedures, and immense psychological stress. For investors, analysts, and healthcare systems, this uncertainty translates into billions in spending on follow-up care that, in most cases, proves unnecessary. bioAffinity’s latest case studies, demonstrating its test’s ability to identify Stage 1A lung cancer in diagnostically challenging scenarios, are not just about improving patient outcomes—they are about building the economic case for a new standard of care.

The High Cost of the Unknown

The widespread adoption of LDCT scans for high-risk individuals has been a double-edged sword. While it has improved early detection rates for the world's deadliest cancer, it has also created a massive cohort of patients with indeterminate pulmonary nodules (IPNs). These small lung lesions, found in a significant percentage of scans, are benign over 95% of the time. However, the low positive predictive value of imaging alone forces clinicians into a defensive and costly posture.

This diagnostic gap creates a significant market need. Patients with IPNs often face a difficult choice: a “watch-and-wait” approach fraught with anxiety, or invasive procedures like bronchoscopy or needle biopsies. These procedures are not only expensive but carry complication rates ranging from 2.3% to as high as 39%, adding further cost and risk to the system. As bioAffinity’s Chief Medical Officer, Dr. Gordon Downie, noted ahead of his presentation, clinicians are often “confronted with conflicting or inconclusive diagnostic data,” leaving them and their patients uncertain about the next steps. This is the multi-billion-dollar problem CyPath® Lung was designed to solve.

A Noninvasive Answer Emerges

CyPath® Lung is not another imaging tool or a complex genetic assay. It is a noninvasive, sputum-based test that leverages advanced flow cytometry and artificial intelligence. The technology is elegant in its approach: a fluorescent porphyrin compound is used, which is preferentially absorbed by cancer and cancer-related cells. When a patient’s sputum sample is analyzed, the test can identify these glowing malignant cells with remarkable precision.

Data from a multi-site validation study, published in the peer-reviewed journal Respiratory Research, underpins the company’s claims. For high-risk patients with small lung nodules—the very group that presents the greatest diagnostic challenge—the test demonstrated 92% sensitivity, 87% specificity, and 88% accuracy. This level of precision offers the potential to confidently stratify patients, guiding those with positive results toward immediate and definitive diagnostic action while reassuring those with negative results, potentially sparing them from unnecessary invasive procedures.

The case studies being presented at the NLCRT highlight this power in practice. By providing clear, actionable results in complex cases where other tools gave conflicting signals, CyPath® Lung moved patients “from uncertainty to clarity and confidence,” enabling confirmed diagnoses at the earliest, most treatable stage of the disease.

The Economic Case for Clarity

For financial analysts and healthcare administrators, the most compelling data may not be clinical but economic. A peer-reviewed economic study published in September 2024 quantified the financial impact of integrating CyPath® Lung into the diagnostic pathway. The results were striking. The study estimated that using the test after a positive LDCT scan could save the U.S. healthcare system over a billion dollars annually.

From a Medicare perspective, the average savings were estimated at $2,773 per patient. For the privately insured population, that figure rose to $6,460 per patient. These savings are not theoretical; they are derived directly from reducing the volume of expensive follow-up assessments and invasive procedures, along with the costs of managing their potential complications. This powerful economic argument is the cornerstone of bioAffinity’s market access strategy.

Reimbursement is already in place from Medicare and several commercial payers, but a recent development has significantly expanded the test’s addressable market. In October 2024, CyPath® Lung was added to the US Federal Supply Schedule, making it available to the vast healthcare networks of the Veterans Administration (VA) and the military. This move provides a crucial channel for adoption and revenue growth, validating the test’s utility for a key high-risk population.

bioAffinity’s Path to Market Penetration

Armed with strong clinical data and a compelling economic argument, bioAffinity Technologies is executing a deliberate commercial rollout. The company is reporting accelerating growth, with test volume in July 2025 surging 72% over the monthly average from the first half of the year. This growth is supported by an expanding network of pulmonology practices, which has grown by 139% since the start of 2024. In parallel, the company has initiated targeted cost-cutting measures to streamline operations and drive its laboratory services subsidiary toward profitability.

Looking ahead, the company’s most significant catalyst lies in its pursuit of full FDA clearance. While CyPath® Lung is currently marketed as a Laboratory Developed Test (LDT), achieving FDA approval as a Class II medical device would unlock broader marketing capabilities, likely enhance reimbursement rates, and streamline international regulatory approvals. This transition is a well-trodden path for successful diagnostics companies, moving a product from a niche service to a globally recognized standard. While the FDA has proposed stricter oversight for LDTs, bioAffinity's proactive pursuit of full clearance positions it to thrive regardless of the regulatory outcome.

The company's ambition is not confined to the United States. With patents secured in key international markets, bioAffinity is planning a stepped expansion into Europe and eventually Southeast Asia. This strategic vision, coupled with ongoing research into applying its platform technology to other lung diseases and cancers, paints a picture of a company building a durable franchise in noninvasive diagnostics. The upcoming presentation is a key part of that buildout, serving as a powerful marketing tool to drive awareness and adoption within the clinical community that will ultimately determine its commercial success.