'CyPath Lung, our noninvasive test for the detection of early-stage lung cancer, is now on CMS' 2024 clinical laboratory fee schedule, a major milestone that facilitates reimbursement by both Medicare and private payers, which in turn should make our test even more attractive to both physicians and their patients at high risk for lung cancer,' bioAffinity Technologies President and CEO
Based on the
In
Physicians can order CyPath Lung from Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. CyPath Lung, a laboratory developed test (LDT), uses flow cytometry to identify cell populations in patient sputum that indicate malignancy. Automated data analysis developed using proprietary artificial intelligence can help determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin, TCPP, that is preferentially taken up by cancer and cancer-related cells. In a clinical trial, CyPath Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Half of all patients in the trial who had cancer were diagnosed in early Stages I or II.
The discovery of small pulmonary nodules as part of annual lung cancer screening using low dose computed tomography (LDCT) can be problematic to diagnose. Patients may be asked to 'wait and see' if the next scan reveals the nodule has grown or proceed immediately with invasive procedures, including biopsy, that may turn out to be unnecessary. 'Actionable results from CyPath Lung may help doctors and their patients determine appropriate next steps for suspected cases of lung cancer,'
About
Forward-Looking Statements
Certain statements in this press release constitute 'forward-looking statements' within the meaning of the federal securities laws. Words such as 'may,' 'might,' 'will,' 'should,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'continue,' 'predict,' 'forecast,' 'project,' 'plan,' 'intend' or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding CMS' 2024 clinical laboratory fee schedule making the Company's test even more attractive to both physicians and their patients at high risk for lung cancer and CyPath Lung helping doctors and their patients determine appropriate next steps for suspected cases of lung cancer. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of the Company to benefit from the 2024 payment determination for CPT 0406U, the ability of the Company's test to produce actionable results to help doctors and their patients determine appropriate next steps for suspected cases of lung cancer, and the other factors discussed in the Company's Annual Report on Form 10-K for the year ended
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