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bioAffinity Technologies Announces Validation Study with Brooke Army Medical Center to Expand Sample Collection Options for the CyPath® Lung Noninvasive Early Detection Lung Cancer Test

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  • bioAffinity Technologies, Inc. announced a new study with Brooke Army Medical Center (BAMC) to validate the clinical utility of the CyPath® Lung diagnostic test for sputum samples obtained via tracheal & bronchial suctioning.
  • The study aims to enroll approximately 30-50 patients undergoing routine suctioning, with results expected by mid-year 2026.
  • Validating deep suction samples could expand the versatility of CyPath® Lung & support broader adoption for early-stage lung cancer detection.
  • CyPath® Lung is currently a noninvasive adjuvant diagnostic that typically requires patients to collect sputum at home & send it to the lab.
  • The new protocol would leverage suctioned samples collected during bronchoscopy & other procedures to improve access for high-risk patients.
  • Bronchoscopy is performed approximately 500,000 times annually in the U.S. within a market valued at $700–$920 million.
  • CyPath® Lung utilizes flow cytometry & proprietary AI to identify malignancy-indicating cell populations in sputum using a fluorescent porphyrin.
  • Clinical results previously demonstrated 92% sensitivity, 87% specificity, & 88% accuracy for detecting lung cancer in patients with indeterminate nodules under 20 millimeters.
  • The test is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
  • Forward-looking statements in the release are subject to risks including study design, enrollment, & potential clinical utility outcomes.