Company sees back-to-back record months in June and July, reaffirms forecast of 3X year-over-year revenue growth for noninvasive lung cancer diagnostic.
BioAffinity Technologies reported a 72% increase in July sales of its CyPath Lung test compared to the average monthly volume for the first six months of 2025, marking the second consecutive record-breaking month for the noninvasive lung cancer diagnostic.
The San Antonio-based biotechnology company says the surge reflects growing physician adoption of the sputum-based test, which uses flow cytometry and artificial intelligence to detect early-stage lung cancer in high-risk patients with indeterminate lung nodules.
“This early Q3 surge is especially encouraging because it reflects increasing awareness and trust in our technology’s ability to support earlier, more accurate diagnosis of lung cancer, especially for high-risk patients with indeterminate lung nodules,” says Maria Zannes, president and CEO of bioAffinity Technologies, in a release.
The company reaffirmed its forecast of 3X year-over-year revenues for CyPath Lung following the strong third-quarter start. The test is marketed as a Laboratory Developed Test by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
Clinical Performance Drives Adoption
Recent case studies demonstrate CyPath Lung’s ability to detect Stage 1A cancer after standard imaging, risk calculator models, and serum marker tests indicated nodules were likely benign. The patients’ final pathology reports confirmed Stage 1A adenocarcinoma, neuroendocrine tumor, and mucinous adenocarcinoma, respectively. The latter two cancer types are often difficult to detect with imaging and bronchoscopy alone.
“The key to improving survival rates for lung cancer is early detection. When lung cancer is found at Stage 1A, there are many curative options,” says Gordon Downie, MD, PhD, chief medical officer of bioAffinity Technologies, in a release.
Clinical study results showed CyPath Lung achieved 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules less than 20 millimeters.
Market Expansion Strategy
The company’s pilot marketing program in Texas, which represents approximately 6% of total US pulmonologists, has demonstrated the effectiveness of its approach to the medical community, according to a release from the company.
“Physician demand, payer coverage, and patient access continue to build a strong foundation for long-term revenue growth,” says J Michael Edwards, bioAffinity Technologies’ chief financial officer, in a release. “We are prepared to meet increased demand as we implement our strategy to enter additional key markets, including our expansion in the Mid-Atlantic region and the Veterans Administration healthcare system.”
The CyPath Lung test incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Automated data analysis helps determine if cancer is present or if the patient is cancer-free.
“Physicians are finding that a CyPath Lung test result—whether it is positive or negative for cancer—can better inform shared decision making between doctor and patient and ease anxiety about appropriate next steps,” says Downie in a release.
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