A breakthrough diagnostic test is making it easier for doctors to catch lung cancer before it becomes advanced, without requiring invasive procedures. CyPath Lung, a noninvasive test developed by bioAffinity Technologies, analyzes sputum (spit) samples using flow cytometry, a laboratory technique that identifies specific cell markers associated with early-stage lung cancer. The test is gaining rapid adoption among physicians and could reshape how millions of Americans with suspicious lung nodules are evaluated. Why Is This Test Getting Attention From Doctors? The numbers tell the story. In 2025, the number of CyPath Lung tests performed nearly doubled compared to 2024, with a 99% year-over-year increase in test volume. Revenue from the test jumped 87% in the same period, reflecting growing clinical confidence in its accuracy. What's driving this adoption? Physicians are ordering the test at a much faster rate, with the number of doctor offices and clinics using CyPath Lung increasing 67% over 2024. The appeal is straightforward: when imaging scans find a suspicious nodule in the lungs, doctors face a difficult decision. Some nodules are cancer; many are not. Traditional approaches often require invasive biopsies or repeated imaging over months or years. CyPath Lung offers a noninvasive alternative that can help clarify whether a nodule warrants aggressive treatment or closer monitoring. How Does the Test Work and What Makes It Different? Unlike biopsies that require a needle or scope to extract tissue from the lungs, CyPath Lung uses a simple sputum sample. Patients cough up a small amount of mucus, which is then analyzed in a laboratory using flow cytometry. This technique detects specific receptors and cell markers that indicate the presence of cancer cells. Because it's noninvasive, patients avoid the risks associated with traditional lung biopsies, including infection, bleeding, and pneumothorax (collapsed lung). The test is particularly valuable for patients with indeterminate pulmonary nodules, meaning nodules that imaging and risk models cannot definitively classify as benign or malignant. According to the U.S. Preventive Services Task Force, the number of indeterminate nodules detected through lung cancer screening and incidental imaging is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030. This expanding population represents an estimated market opportunity exceeding $4.7 billion for CyPath Lung. What's Next for Lung Cancer Detection and Beyond? bioAffinity Technologies is expanding the application of its sputum-based testing platform beyond lung cancer. The company is conducting research and development on diagnostic tests for chronic obstructive pulmonary disease (COPD) and asthma, two conditions that affect approximately 650 million children and adults globally. These new tests would use the same sputum sampling approach to detect specific receptors that guide personalized treatment and identify patients likely to benefit from emerging targeted therapies. Patient studies for these conditions are expected to begin in 2026. The company has also strengthened its intellectual property portfolio significantly. During 2025, the U.S. Patent and Trademark Office issued allowances for the diagnostic algorithm and test method, while Canada and China granted patents covering flow cytometry-based lung cancer detection methods. Australia accepted patent applications related to early-stage lung cancer detection and multi-disease lung health assessment. These protections support long-term commercialization and international expansion. How to Understand Your Lung Cancer Risk and Testing Options - Screening Eligibility: If you are between 50 and 80 years old with a 20 pack-year smoking history (smoking one pack per day for 20 years, or equivalent), you may qualify for low-dose CT screening that can detect nodules early. - Nodule Evaluation: If imaging finds a suspicious nodule, ask your doctor whether CyPath Lung or similar noninvasive tests are appropriate before pursuing invasive biopsies. - Surveillance After Treatment: Lung cancer survivors often require long-term monitoring to detect recurrence. CyPath Lung is being studied as a tool for post-treatment surveillance, potentially offering a simpler alternative to repeated imaging. - Physician Network Growth: The expanding network of physicians ordering CyPath Lung means more medical centers now have access to the test; ask your primary care doctor or pulmonologist whether it's available in your area. The clinical momentum is clear. Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies, stated: "Every day, we hear from practitioners who confirm the need for noninvasive, accurate lung cancer diagnostics, particularly when imaging and risk models are inconclusive or turn out to be wrong. CyPath Lung remains our first priority. It is a gamechanger that provides clinical confidence for physicians and better outcomes for patients". Looking ahead, bioAffinity forecasts that unit sales of CyPath Lung will increase more than 100% in 2026 compared to 2025, with corresponding revenue growth. The company is also launching a longitudinal trial enrolling up to 2,000 patients across 17 Veterans Administration, military, academic, and private medical centers to further validate the test's sensitivity and specificity in high-risk populations. For patients and physicians alike, the emergence of noninvasive lung cancer diagnostics represents a meaningful shift in how we approach indeterminate nodules and post-treatment surveillance. As adoption accelerates and new applications for respiratory diseases expand, this technology may become a standard part of lung health assessment for millions of Americans.
