NEW YORK (GenomeWeb) – Cancer Genetics has received CE marking for its DNA probe-based in vitro diagnostic cervical cancer screening test, the company said today.
The CE mark, which shows a product is in compliance with European Union safety laws, will enable the company to market the FISH-based HPV-associated Cancer Test (FHACT) freely in the European Economic Area, which includes the EU member states and the European Free Trade Association, or 31 nations in all.
The FHACT test uses DNA-FISH probes to identify women who are most at risk for cervical disease by screening for genomic changes related to cancer progression. The test can be used on leftover prep specimens and convention Pap smears.
In addition to identifying women at highest risk for cervical disease, the test also can reduce unnecessary and invasive testing and over-treatment among women who are at a lower risk for disease progression, the Rutherford, NJ-based company said.
"Cervical cancer screening is evolving, but there remains a need for more definitive and genomically informed diagnosis," Cancer Genetics CEO Panna Sharma said in a statement.
Having the CE mark will enable the company to expand its FHACT sales in Europe and allow wider global adoption, said he added.