| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
bioAffinity Technologies, Inc. (NASDAQ:BIAF, BIAFW))), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other lung diseases, today 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.
"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 Maria Zannes said. "The CMS payment determination is an important achievement in our strategic plan to ramp up the commercialization of CyPath® Lung."
Based on the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests recommendation, CMS previously released a preliminary payment decision for the Current Procedural Terminology (CPT) code specific to CyPath® Lung. For the calendar year 2024 Medicare Clinical Lab Fee Schedule, CMS finalized the panel's recommendation for CyPath® Lung for purposes of payment by Medicare. This payment information also serves as a reference for private payers and other public health insurance programs.
In June 2023, the American Medical Association (AMA) issued the CPT Proprietary Laboratory Analyses (PLA) code 0406U for CyPath® Lung with the descriptor "Oncology (lung), flow cytometry, sputum, 5 markers (meso-tetra [4- carboxyphenyl] porphyrin [TCPP], CD206, CD66b, CD3, CD19), algorithm reported as likelihood of lung cancer." CMS released a preliminary payment decision in September 2023, agreeing with the Medicare Advisory Panel's recommendation. In November 2023, CMS finalized the 2024 payment determination for CPT 0406U, effective January 1, 2024.
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," Ms. Zannes said.
Posted In: BIAF
