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bioAffinity Technologies Advances CyPath® Lung for Surveillance of Lung Cancer Survivors

  • More than 680,000 Americans with a history of lung cancer require ongoing surveillance as of January 1, 2025.
  • bioAffinity Technologies, Inc. is advancing the CyPath® Lung test for monitoring recurrence & new cancers in patients who completed curative-intent treatment.
  • Lung cancer recurrence rates for non-small cell lung cancer (NSCLC) range from 20% to 55% even when patients have no evidence of disease following surgery or radiation.
  • The CyPath® Lung test analyzes the lung microenvironment in real time using flow cytometry & proprietary artificial intelligence to identify malignancy-indicating cell populations in sputum.
  • Clinical trials demonstrated 92% sensitivity, 87% specificity, 88% accuracy, & 99% negative predictive value for detecting lung cancer in high-risk patients with small indeterminate nodules.
  • Physicians state the test's binary result helps determine which patients need closer investigation while sparing others from unnecessary invasive procedures.
  • The test is marketed as a Laboratory Developed Test (LDT) & is not intended for use as a sole diagnostic tool.
  • The Company's commercial experience with CyPath® Lung has shown promising performance in stratifying malignancy risk & guiding patient management.
  • Forward-looking statements regarding expanding the test into post-treatment surveillance are subject to risks including regulatory developments & the Company's limited operating history.