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bioAffinity Technologies Announces Initiation of Large-Scale Longitudinal Clinical Study for Its Noninvasive CyPath® Lung Cancer Diagnostic

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  • bioAffinity Technologies, Inc. announced the initiation of a 2,000-patient longitudinal clinical study to evaluate CyPath® Lung, a noninvasive flow cytometry test for early-stage lung cancer detection.
  • The study targets high-risk individuals with existing lung nodules ranging from 6mm to less than 30mm in diameter identified via screening.
  • Up to 20 clinical sites will participate, including a dozen Department of Veterans Affairs medical centers & two major military hospitals.
  • Michael J. Morris, MD, serves as the national Principal Investigator for the trial, which is identified by NCT07168993.
  • The John P. Murtha Cancer Center Research Program at Uniformed Services University of the Health Sciences is providing support & funding for the trial at federal facilities.
  • The trial will evaluate FlowPath Lung, a research-use version of the technology that follows the same procedures as the commercially available CyPath® Lung test.
  • Previous clinical trials demonstrated 92% sensitivity, 87% specificity, & 88% accuracy for detecting lung cancer in patients with small pulmonary nodules under 20mm.
  • Patient enrollment is expected to take up to 18 months, with follow-up periods extending up to 24 months or until a definitive diagnosis is reached.
  • Physicians currently order CyPath® Lung as a laboratory developed test (LDT) through bioAffinity's subsidiary Precision Pathology Laboratory Services for patients with indeterminate lung nodules.
  • The test utilizes advanced flow cytometry & proprietary artificial intelligence to identify malignancy-indicating cell populations in sputum samples using fluorescent porphyrin.
  • bioAffinity Technologies aims to use the robust real-world data from this study to establish CyPath® Lung as part of the standard of care for high-risk lung cancer evaluation.