03 Mar 2020 – MedTech Insights – The US Centers for Medicare and Medicaid Services is considering a national coverage determination for a blood-based biomarker screening test for colorectal cancer after receiving a request for a national coverage determination from Epigenomics for its Epi proColon assay.
The US Centers for Medicare and Medicaid Services on 28 February opened up a national coverage analysis tracking sheet on blood-based biomarker screening tests for colorectal cancer. The CMS tracking sheet was triggered by a request from Epigenomics to consider coverage of its Epi proColon assay.
In an April 2019 letter to the CMS first asking that that Epi proColon be considered for colorectal cancer screening, Jorge Garces, president and chief scientific officer of Epigenomics AG, said the assay “fills a major unmet medical need.”
Garces described the assay as a qualitative in vitro diagnostic for the detection of methylated Septin 9 DNA in EDTA plasma – fluid that is removed after centrifugation of anticoagulated whole blood.
The FDA began a one-month public comment period on Epigenomics’ request, from 28 February to 29 March, and said it will issue a proposed decision memo on its national coverage determination on 28 August, with an expected completion date of 26 November.
The assay fills an unmet medical need, Garces said, because “participation in colorectal screening remains suboptimal in the general US population over 50, and in Medicare beneficiaries.”
“Methylation of the target DNA sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer,” Garces told the CMS, which agreed. He added that the test uses a real-time polymerase chain reaction (PCR) with a fluorescent hydrolysis probe for detection of the Septin 9 DNA target.
“As the Epi proColon test is not a fecal occult blood assay, or a screening flexible sigmoidoscopy or a screening colonoscopy, it is not currently a covered colorectal cancer screening test,” Garces said, but he noted that the CMS “has the authority to provide coverage for other test procedures.”