Cervical Cancer Screening Test Receives Approval for the European Sector

A screening test that detects the clonal chromosomal aberrations (gains or amplifications) commonly found in cervical cancer specimens has received CE-marking that allows it to be distributed as a diagnostic test in the 28 countries making up the European Economic Area.

The Cancer Genetics Inc. (Rutherford, NJ, USA) FISH (fluorescence in situ hybridization)-based HPV-Associated Cancer Test (FHACT) utilizes the only four color FISH probe that can be used for cervical cancer screening as additional triage before referral for colposcopy.

The FISH analysis is performed on nuclei of cells derived from a liquid pap specimen using the FHACT combination probe manufactured by CGI Italia (Milan, Italy), a wholly owned subsidiary of Cancer Genetics Inc. The probe comprises 3q26 (TERC) (red), 5p15 (D5S2095) (green), 20q13 (D20S911) (gold), and CEP7 (aqua).

The FISH probe has been optimized to identify copy number gains of 3q26, 5p15, chromosome 7, and 20q13. In normal diploid interphase and metaphase cells, FHACT generates two red, two green, two blue, and two gold signals corresponding to the normal chromosomes 3, 5, 7 and 20 respectively. In cells with gain or amplification of 3q26, 5p15, 20q13 and/or chromosome 7, the number of red, green, gold, and/or blue signals will be greater than two each.

The FHACT test identifies irreversible genomic changes associated with progression to cancer. In addition to identifying those women most at risk for cervical disease, it can help reduce unnecessary, invasive testing and over-treatment in women who do not show the genomic abnormalities associated with disease progression.

"We are committed to the highest level of quality in the development and manufacture of our DNA-FISH probes and tests. Our probes are manufactured to meet or exceed all established quality and performance specifications, and comply with relevant safety and regulatory requirements in order to qualify them for CE marking," said Panna Sharma, CEO of Cancer Genetics, Inc. "Cervical cancer screening is evolving, but there remains a need for more definitive and genomically informed diagnosis. Our proprietary cervical cancer test, FHACT, was designed in response to this need. Having it affixed with the CE-mark will allow us to expand our marketing and sales in Europe, and allow for greater adoption of the test globally."

The FHACT method is protected by several US and international patents.

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Cancer Genetics Inc.
CGI Italia