bioAffinity Technologies, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of non-invasive, immunoassay-based tests for the early detection and monitoring of cancer. Founded in 2009 and incorporated in the Cayman Islands, the company maintains its principal executive offices in Miami, Florida. bioAffinity’s platform leverages proprietary monoclonal antibodies to target epigenetic biomarkers, enabling sensitive and specific assays suitable for routine laboratory use.
The company’s lead product candidate, the UMA-1™ Bladder Cancer Test, is a urine-based assay designed to detect bladder cancer at its earliest stages. By identifying aberrant methylation patterns in urinary cells, UMA-1 aims to offer clinicians a convenient alternative to invasive cystoscopy procedures and improve patient compliance with surveillance protocols. bioAffinity is also advancing a pipeline of additional assays for the detection of lung and colorectal cancers, employing the same immunoassay technology to address diagnostic gaps across multiple tumor types.
bioAffinity operates through partnerships with CLIA-certified laboratories in the United States and is seeking regulatory clearances to expand its market reach. The company’s strategy includes collaboration with academic medical centers and diagnostic laboratories to validate its assays in diverse patient populations. In parallel, bioAffinity is exploring distribution agreements for international markets, with a focus on regions where non-invasive testing could alleviate healthcare system burdens and reduce overall diagnostic costs.
Leadership at bioAffinity comprises seasoned executives and board members with extensive experience in molecular diagnostics, oncology, and commercial development. Michael McMahon serves as President and Chief Executive Officer, guiding corporate strategy and clinical development programs. Under this leadership, bioAffinity continues to build its intellectual property portfolio, advance regulatory filings, and establish strategic collaborations aimed at transforming cancer diagnostics through innovative, patient-friendly testing solutions.
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