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New Legislation for Blood Based Testing for Colorectal Cancer Screening


Posted on October 10, 2016 by J Seabrook

The 'Donald Payne Sr. Colorectal Cancer Detection Act of 2016" was introduced by Congressman Donald M. Payne, Jr. (D-NJ) and co-sponsored by Congressman Charles Dent (R-PA) and Congressman John Delaney (D-MD) in Washington D.C on Sept 29th. Its purpose to provide Medicare coverage for all FDA-approved blood-based screening tests with available screening methods and authorize equivalent CMS reimbursement. This enables underserved communities to more fully participate in screening.


"Bill seeks to provide Medicare coverage for FDA-approved qualifying
colorectal cancer screening blood-based tests"

"We need new and innovative tools to reach these patients,” said Congressman Donald M. Payne, Jr. “While the Food and Drug Administration has recently approved a new blood-based screening test, which will enable historically underserved communities to more fully participate in screening, the Centers for Medicare & Medicaid Services reimbursement is not yet aligned with it. For this reason, I have introduced legislation that would include all FDA-approved blood-based screening tests with available screening methods and authorize equivalent CMS reimbursement. By doing so, we can finally close the gap and screen the unscreened.”

Nicholas Potter, PhD., Executive Vice-President of Clinical Affairs, Molecular Pathology Laboratory Network. in a press release this week by Epigenomics AG stated “The advances in molecular diagnostics have provided us with a disruptive technology to reach the 1 in 3 who have avoided colorectal cancer screening,” He further went on to say that “The introduction of a novel DNA blood test has the potential to increase compliance with colorectal cancer screening, as demonstrated in clinical studies.”

MPLN, through its subsidiary, Geneuity Clinical Research Services, was one of three laboratories supporting the PRESEPT (Prospective Evaluation of Septin9 Performance for Colorectal Cancer Screening) clinical trial (1,2,3).  Dr. Potter presented the "Analytical Validation and Pivotal Clinical Trial Data" to the FDA at the Molecular and Clinical Genetics Panel Meeting to the Medical Devices Advisory Committee March 26, 2014. The Advisory Committee meeting was part of Epigenomics PMA submission to the FDA for approval of Epi proColon. Epigenomics received FDA approval for Epi proColon in April 2016.

  1. Liles EG, Coronado GD, Perrin N,Howell-Harte, Nungesser R, Quigley N, Potter N, Weiss G, Koenig T, deVos . Patient uptake of colorectal cancer screening is higher with a blood test than with a fecal immunochemical test. T. Clin J Gastroenterol Hep: submitted (2016).
  2. Johnson DA, Barclay RL, Mergener K, Weiss G, Koenig T, Beck J, and Potter NT. 2014. Plasma septin9 versus fecal immunochemical testing for colorectal cancer screening. A Prospective, Multicenter Comparison. PLoS ONE 9(6):e98238.
  3. Potter NT et al. 2014. Validation of a real-time PCR-based qualitative assay for the detection of methylated SEPT9 DNA in human plasma.Clin Chem.  Sep;60(9):1183-91

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