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NeoDiagnostix is a molecular diagnostics company that specializes in the development of advanced screening tests for cervical cancer. The company's core technology utilizes Fluorescence In Situ Hybridization (FISH) to detect chromosomal abnormalities, specifically the gain of the TERC gene, which is a known marker for the progression of HPV infections to invasive cancer. Its lead product, CervicalSURE, was designed to provide clinicians with a more accurate risk assessment for patients with abnormal Pap smears or high-risk HPV results. By identifying which patients are at the highest risk for developing high-grade lesions, the company aimed to reduce the number of unnecessary colposcopies and biopsies. In December 2014, NeoDiagnostix was acquired by Cancer Genetics, Inc. to enhance their portfolio of genomic-based oncology tests. The acquisition integrated NeoDiagnostix's CLIA-certified laboratory and proprietary testing services into Cancer Genetics' broader clinical offering.
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