CyPath® Lung avoids biopsy
A new case study shows bioAffinity’s CyPath® Lung sputum assay produced actionable results that let clinicians delay or avoid an invasive lung biopsy in a high‑risk patient—supporting reported sensitivity of 92%, specificity 87%, and accuracy 88%. This real‑world example underscores how noninvasive cytology/flow‑based tests are already changing triage for small nodules under 20 mm. (biospace.com)
The patient detailed in the case study was a 71‑year‑old former 20‑pack‑year smoker with prior right‑lower‑lobe pneumonia and multiple pulmonary nodules, and clinicians chose surveillance instead of immediate biopsy after CyPath® Lung informed the decision; a subsequent follow‑up scan reportedly showed no residual nodules. (financialcontent.com) CyPath® Lung analysis combines high‑parameter flow cytometry with proprietary artificial‑intelligence–based data analysis and incorporates a fluorescent porphyrin that the company says is preferentially taken up by cancer and cancer‑related cells in sputum. (bioaffinitytech.com) The test is marketed as a Laboratory‑Developed Test (LDT) through Precision Pathology Laboratory Services, and physicians are reported to receive results within three days of the laboratory receiving the sputum sample. (precisionpath.us) bioAffinity announced a validation study with Brooke Army Medical Center to evaluate CyPath® Lung on deep‑suction bronchoscopic/tracheal samples, with a planned enrollment of approximately 30–50 patients and results expected by mid‑2026. (businesswire.com) The company publicly initiated a large‑scale, longitudinal clinical study for CyPath® Lung on March 10, 2026, to expand evidence of clinical utility, while company materials and the Precision Path FAQ describe a planned pivotal study enrolling roughly 2,000 high‑risk patients across about 20 collection sites over two years. (businesswire.com) bioAffinity reported rapid commercial growth for CyPath® Lung in its March 13, 2026 release, stating 2025 CyPath revenue increased 87% year‑over‑year and the number of tests performed rose 99% versus 2024 as the company focused lab operations on its diagnostic service. (ir.bioaffinitytech.com)
