bioAffinity Technologies Reports 146% Growth in CyPath Lung Test Sales as Clinical Case Studies Demonstrate Diagnostic Value
核心洞察
bioAffinity Technologies' CyPath Lung (搜索) diagnostic test achieved 146% year-over-year unit sales growth in Q1 2026, exceeding internal projections and reflecting accelerating physician adoption.
A new case study demonstrates how the noninvasive test helped avoid unnecessary biopsy in a 79-year-old patient with a suspicious lung nodule, with follow-up imaging confirming the test's negative result.
The flow cytometry and AI-based diagnostic addresses a growing market projected to reach $3.58 billion for pulmonary nodule management and lung cancer survivor surveillance.
bioAffinity Technologies announced that unit sales for its CyPath Lung (搜索) diagnostic test surged 146% year-over-year in the first quarter of 2026, based on preliminary unaudited data, significantly exceeding internal projections. The noninvasive lung cancer diagnostic test is gaining traction in what the company describes as a $3.58 billion addressable market for pulmonary nodule management and surveillance of lung cancer survivors.
The strong commercial performance coincides with new clinical evidence supporting the test's utility in clinical decision-making. A recently published case study demonstrates how CyPath Lung (搜索) helped avoid an unnecessary invasive procedure in a high-risk patient with suspicious imaging findings.
Clinical Case Validates Conservative Management Approach
The case study involved a 79-year-old female current smoker with a medical history of chronic obstructive pulmonary disease (COPD) and coronary heart disease who underwent low-dose computed tomography (LDCT) screening in June 2025. Imaging revealed a spiculated nodule approximately half an inch in size at the bottom of the right lung, near the lung lining.
"Spiculated findings on CT scans often trigger concern and can lead to invasive procedures, particularly in older high-risk patients," said Dr. Daya Nadarajah, the patient's pulmonologist. "Given this patient's age, smoking history and comorbidities, we were not comfortable proceeding directly to an invasive procedure. CyPath Lung (搜索) gives us objective data to better stratify risk and avoid putting our patients through unnecessary and potentially risky procedures."
The CyPath Lung (搜索) test result was negative, indicating unlikely malignancy and supporting a conservative management approach with annual CT screening. A repeat scan in October 2025 confirmed the test's accuracy, showing that the suspicious finding had resolved and no pulmonary nodules were present in the lungs.
Technology Platform and Performance Metrics
CyPath Lung (搜索) uses advanced flow cytometry combined with proprietary artificial intelligence to identify cell populations in patient sputum that indicate malignancy. The test incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells, providing a binary result of "likely" or "unlikely" malignancy to ordering physicians.
Clinical study results have demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
Expanding Market Opportunity
The number of patients with indeterminate pulmonary nodules continues to rise, driven by increases in incidental findings and screening by low-dose CT for high-risk patients. According to estimates from the U.S. Preventive Services Task Force cited by bioAffinity Technologies, the number of indeterminate pulmonary nodules detected in the U.S. through lung cancer screening and incidental imaging is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030.
The number of people living with a prior lung cancer diagnosis is projected to increase from 680,000 to more than 871,000 by 2030. The company estimates that capturing only 10% of both markets represents sales of $358 million for CyPath Lung (搜索), growing to more than $560 million over the next five years, assuming 10% compound annual growth from 2024-2030.
Commercial Strategy and Growth Drivers
"The stronger than expected unit growth in the first quarter of 2026 reflects growing recognition of the value that CyPath Lung (搜索) brings to clinical decision-making and patient outcomes," said Maria Zannes, President and CEO of bioAffinity Technologies. "Physicians are seeking more accurate, noninvasive tools to assess lung cancer risk and detect disease at its earliest, most treatable stage."
The company has prioritized CyPath Lung (搜索) as its core commercial focus, with growth driven by expansion of ordering physician sites, increased peer-to-peer education among pulmonologists, and integration into clinical workflows for lung cancer risk assessment and nodule management.
Based on audited financial results, CyPath Lung (搜索) revenue increased 87% year-over-year in 2025, while test units sold grew 99% compared to 2024.
Future Development Pipeline
bioAffinity Technologies is advancing multiple initiatives to expand its proprietary technology platform, including a large-scale longitudinal clinical study designed to generate additional validation data for CyPath Lung (搜索), broader use for monitoring lung cancer survivors after treatment, and an R&D pipeline that includes diagnostic tests for asthma and COPD to guide personalized treatment with targeted therapies.
CyPath Lung (搜索) is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services (搜索), a subsidiary of bioAffinity Technologies, and is overseen under the Clinical Laboratory Improvement Amendments (CLIA) administered by the Centers for Medicare & Medicaid Services.