Diamics, a Novato, CA, diagnostics company, has received CE Mark approval for a molecular-based cervical cancer-screening tool designed to improve the effectiveness of traditional testing methods.
The Pap-Map System — which uses Diamics’ FDA-approved CerCol Cervical Cancer Collection System, for collecting cellular and fractional histological material from the entire cervix with a single, soft-tipped device — provides a “map” of collected cervical material. The system helps guide physicians’ diagnoses and decisions about subsequent colposcopy and biopsy procedures.
Diamics says the system delivers more accurate, localized and definitive information than that provided by traditional screening methods. The company claims it reduces overall cervical cancer-screening and diagnostic costs as well.
Cancer of the cervix is the second most commonly diagnosed cancer in women worldwide. Approximately 500,000 new cases are diagnosed each year, 80 percent of which occur in developing countries. It is estimated that of the more than 2.5 billion females worldwide who are eligible for cervical-cancer testing, only approximately 6 percent, or 160 million, are screened routinely.
Granted in the Netherlands, the CE Mark registration allows the Pap-Map system to be marketed in the European Union and other countries around the world that recognize the CE Mark.