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Clinical Utility of bioAffinity Technologies' CyPath® Lung Test Demonstrated in Real-World Case Study

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  • bioAffinity Technologies announced a clinical case study demonstrating how its CyPath® Lung test aids in managing high-risk patients with multiple pulmonary nodules.
  • The 59-year-old patient had a 30-year smoking history, COPD, and multiple nodules categorized as Lung-RADS 3, indicating a probably benign condition.
  • CyPath® Lung returned a negative result of "unlikely malignancy," providing confidence to continue a six-month serial CT surveillance schedule per Lung-RADS 3 guidelines.
  • Follow-up imaging confirmed the sub-centimeter nodules remained stable, validating the noninvasive management approach.
  • Clinical study results show CyPath® Lung achieved 92% sensitivity, 87% specificity, & 88% accuracy for detecting lung cancer in nodules under 2 centimeters.
  • The test utilizes advanced flow cytometry & proprietary artificial intelligence to identify malignancy-indicating cell populations in patient sputum.
  • A proprietary fluorescent porphyrin is used in the test, which is preferentially taken up by cancer & cancer-related cells.
  • Benefits of using CyPath® Lung include supporting evidence-based surveillance, reinforcing guideline-consistent follow-up intervals, potentially reducing invasive procedures, & alleviating patient anxiety.
  • CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.