bioAffinity Technologies, Inc. (BIAF) has begun a 2,000‑patient longitudinal study to evaluate the clinical performance of its CyPath Lung sputum‑based flow cytometry test for early‑stage lung cancer detection in high‑risk individuals with pulmonary nodules between 6 mm and less than 30 mm in diameter. The study will enroll patients across multiple sites and will follow them for up to 24 months, providing real‑world data on sensitivity, specificity, and clinical utility that the company says will support future regulatory submissions and reimbursement discussions.
CyPath Lung has previously demonstrated strong performance in smaller trials, reporting 92 % sensitivity and 87 % specificity in patients with nodules under 20 mm. The new study will use the research‑use version, FlowPath Lung, to differentiate it from the commercially available laboratory‑developed test (LDT). The test’s non‑invasive sputum collection positions it as a potential bridge between watchful waiting and invasive procedures, a point highlighted by Chief Medical Officer Gordon Downie: "As more indeterminate pulmonary nodules are found either incidentally or by routine lung cancer screening, CyPath Lung can fill the diagnostic gap between 'watchful waiting' and invasive procedures that carry risk."
The company’s CEO Maria Zannes emphasized the strategic importance of the study: "Initiating this study represents an important milestone for CyPath Lung. By following patients longitudinally across multiple sites, we expect to acquire robust, real‑world data that reflects how CyPath Lung may be used to support risk assessment and clinical decision‑making aligned with our objective to establish CyPath Lung as a standard of care for evaluating patients at high‑risk for early‑stage lung cancer." The data will underpin BIAF’s pivot toward a pure‑play precision diagnostics model and will be critical for engaging payers and regulators, given that CyPath Lung remains an LDT and has not yet received FDA clearance.
Financially, BIAF is a development‑stage company with 2024 revenue of $9.36 million and a net loss of $9.04 million, a decline from 2023. The company’s stock has experienced significant volatility, trading around $1.04 on March 10, 2026, after a 12.26 % rise in the prior 24 hours, but has fallen 89.28 % over the past year and hit an all‑time low of $0.69 in February. Analysts have issued a Hold rating with a $1.00 price target, reflecting the company’s financial challenges despite the positive clinical development.
The study is supported by the John P. Murtha Cancer Center Research Program and involves federal facilities, including U.S. Department of Veterans Affairs medical centers and military hospitals, lending credibility and access to a diverse patient population. The global lung cancer diagnostics market is projected to grow from $3.39 billion in 2024 to $9.81 billion by 2032, a CAGR of 14.20 %. BIAF’s non‑invasive approach could capture a share of this expanding market, but the company’s distressed financial position and the long timelines required for clinical data collection and regulatory approval remain significant headwinds.
The announcement signals a key step toward establishing CyPath Lung as a standard of care, but investors will weigh the study’s potential against BIAF’s ongoing financial challenges and the regulatory uncertainty surrounding an LDT that has yet to receive FDA clearance.
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