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Cancer Genetics Lands Conditional NY State Approval for FHACT Cervical Cancer Test

NEW YORK (GenomeWeb) – Cancer Genetics today announced it has received conditional licensure from the New York State Department of Health for its FISH-based HPV-Associated Cancer Test (FHACT) for cervical cancer.

The test, which received US approval as a laboratory-developed test under CLIA in late 2013, assesses genomic changes often found in cervical cancers and can identify women who are at higher risk for disease progression, the firm said in a statement. 

"There continues to be a significant unmet need for more definitive and genomically informed diagnosis of cervical cancer," Cancer Genetics CEO Panna Sharma, said in a statement, adding that FHACT was designed to respond to that need. "Receiving New York State licensure for FHACT will allow us to expand our efforts to drive greater adoption of the test in the United States." 

The firm added that it expects to receive data later this year from clinical studies validating the use of the test.

Rutherford, NJ-based Cancer Genetics received CE marking for the FHACT test in September 2014.