CINtec Histology
Commercial- Indications
- Cervical cancer
Company intelligence / Profile preview
CINtec® PLUS Cytology was launched in Europe in March 2010. It underwent three large European clinical trials involving over 32,000 women. The product demonstrated high sensitivity and specificity for underlying cervical disease. It received CE Mark approval with claims for primary screening, triage of ASC-US/LSIL cytology results, and management of HR‑HPV positive/Pap-negative cases[2]. In the US market as of the last available update before acquisition, products were available as Class I IVDs without specific claims pending FDA clearance[2]. The company was acquired in a deal valued at EUR 190 million[4].
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