The company claims that the new test is based on DNA methylation of the Septin9 gene, a biomarker associated with colorectal cancer that was identified by Epigenomics, a cancer molecular diagnostics company. Quest Diagnostics said that it is the first commercial laboratory in the US to offer a laboratory-developed test based on the Septin9 biomarker.
Epigenomics has demonstrated in more peer-reviewed studies involving approximately 3,000 specimens of patients with diagnosed colorectal cancer and of healthy control subjects, that methylated Septin9 in blood plasma indicates an increased likelihood of colorectal cancer.
Epigenomics is sponsoring a multi-center clinical study named PRESEPT in collaboration with Quest Diagnostics and other organizations to evaluate the Septin9 biomarker’s performance for colorectal cancer screening in screening-guideline-eligible individuals, who have not been diagnosed with colorectal cancer.
Epigenomics expects to conclude the PRESEPT trial early, with the release of preliminary data, and publish the detailed findings later in 2010.
Additionally, Quest Diagnostics’ InSure fecal immunochemical test (FIT) is an FDA-cleared fecal occult blood test (FOBT) for use in screening for sources of lower gastrointestinal bleeding, based on laboratory testing of a stool-based specimen.
