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CINtec® Histology is the only 510(k) p16 immunohistochemistry biomarker test for clinical/IVD use in the evaluation of cervical biopsy specimens.
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CINtec® Histology is a pioneering diagnostic brand focused on improving cervical cancer detection through advanced biomarker testing. As the only U.S. FDA 510(k) and CE-marked p16 immunohistochemistry test for clinical use, CINtec® Histology provides an essential tool for pathologists evaluating cervical biopsy specimens. By enhancing diagnostic consistency and objectivity, the test empowers medical professionals to identify cervical precancer and high-grade lesions more accurately.
CINtec® Histology is designed to support pathologists in making informed decisions, reducing the risk of misdiagnosis, and ensuring that the right patients receive appropriate care without unnecessary treatments. The test demonstrates significant improvements in diagnostic sensitivity and specificity, critical for effectively managing cervical disease.
With a robust portfolio that includes training resources and support for healthcare professionals, CINtec® Histology exemplifies innovation in diagnostics and remains committed to advancing cervical cancer detection and treatment outcomes.
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