TEST:

CyPath® Lung

"bioAffinity Technologies...published the peer-reviewed paper...in the journal Cytometry Part B: Clinical Cytometry, the official journal of the International Clinical Cytometry Society....The paper supplements the Clinical and Laboratory Standards Institute (CLSI) Guideline H62, the standard for validating assays performed by flow cytometry issued in 2021, by addressing challenges and considerations in validation with unique sample types....The paper notes, 'Factors such as high viscosity, presence of inhibitors, cellular debris or other artifacts, complex cellular mixtures, or unique tissue and cellular morphology might necessitate adjustments to standard flow cytometry techniques to achieve accurate and reliable results'."

"bioAffinity Technologies, Inc...announced that CyPath Lung, its noninvasive test to detect early-stage lung cancer, will be added to the U.S. Federal Supply Schedule, a procurement system that provides the Veterans Health Administration (VHA) and the Military Health System streamlined access to state-of-the-art healthcare products and services."

"A new economic study found that adding CyPath® Lung, bioAffinity Technologies’ noninvasive test for detection of early-stage lung cancer, to the standard of care for Medicare patients with a positive lung cancer screening could have saved an average of $2,773 per patient for total cost savings of $379 million in 2022. The peer-reviewed study, 'Economic Evaluation of a Novel Lung Cancer Diagnostic in a Population of Patients with a Positive Low-Dose Computed Tomography Result,' attributes the savings to a reduction in follow-up diagnostic assessments, expensive follow-up procedures and procedure-related complications."

"bioAffinity Technologies, Inc...reported 139% growth in the number of pulmonology practices and physicians offering CyPath® Lung to patients since Jan. 1, 2024. CyPath® Lung is a noninvasive test to detect early-stage lung cancer."

"bioAffinity Technologies, Inc...announced that the Centers for Medicare and Medicaid Services (CMS) has made a final determination for payment for CyPath® Lung, a noninvasive test for early-stage lung cancer, for the 2024 calendar year."

"bioAffinity Technologies, Inc...launched a campaign in partnership with the American Cancer Society (ACS) to increase lung cancer screening in Texas...The campaign highlights the work of ACS and UT Health and provides information about bioAffinity Technologies’ CyPath® Lung, a noninvasive test to improve early detection of lung cancer."

"bioAffinity has its eyes on expanding sales of its sputum-based lung cancer test nationwide through its recent acquisition of the pathology laboratory that had licensed and developed that technology into a laboratory-developed test...According to its CEO, a national launch of the test called CyPath Lung could happen in 2024."

"bioAffinity Technologies, Inc...announces the acquisition of the laboratory assets of Village Oaks Pathology Services, P.A., d/b/a Precision Pathology Services, a clinical laboratory accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The laboratory assets are being acquired by a new wholly owned subsidiary of bioAffinity Technologies, Precision Pathology Laboratory Services, LLC (PPLS). bioAffinity Technologies management will host a conference call today to discuss the acquisition....This transaction gives bioAffinity the opportunity to build a commercial laboratory with scale with the goals of accelerating the market uptake and success of CyPath® Lung, supporting the test’s upcoming 1,800-patient FDA pivotal trial, and pursuing the development and commercialization of additional tests."

"bioAffinity Technologies, Inc...announced that the American Medical Association (AMA) has released a Current Procedural Terminology (CPT) code specifically for use with CyPath® Lung, a noninvasive test for early-stage lung cancer...The reimbursement code for CyPath® Lung will be effective Oct. 1, 2023."

"bioAffinity Technologies, Inc...will present the poster 'Development of porphyrin-stained polystyrene compensation beads for use on an automated analysis platform' at CYTO 2023, the annual Congress for the International Society for the Advancement of Cytometry (ISAC), in Montréal, Québec, Canada. ISAC’s mission is to advance the impact of cytometry to meet current and emerging challenges in the life, biomedical and physical sciences."

"The presentation by...bioAffinity Technologies Executive Vice President and Chief Science and Medical Officer, will focus on advancements in CyPath® Lung, the Company’s noninvasive test for detection of early-stage lung cancer. CyPath® Lung uses flow cytometry and artificial intelligence to analyze the lung microenvironment to identify cell populations that accurately predict cancer in patients at high risk for lung cancer."