All posts in “Industry News”

Geneuity study data published – randomized trial comparing uptake of blood based test versus FIT in the clinic – colorectal cancer screening

Results of the study with the blood test Epi proColon® is now published in the journal of “Cancer Treatment and Research Communications” . Epigenomics AG announced that the results of the ADMIT study confirm that a blood-based colorectal cancer screening test has the potential to increase the participation in colorectal cancer screening compared to a fecal test.

MPLN’s Nicholas Potter and Geneuity’s Neil Quigley are co-authors on the recent paper in cancer treatment and research communications concerning colorectal cancer screening programs. This study compares uptake of an experimental blood test (Epi proColon IVD) with that of a FIT for colorectal cancer screening in an office setting. Dr. Potter provided study design, analysis, interpretation of data and statistical analysis. Dr. Quigley was the site principal investigator, providing study supervision and data acquisition. Additionally Geneuity’s Donald Henley, Kara Whitlock and Daniel Thomas provided technical assistance for the study.

Liles E.G, Coronado G.D, Perrin N, Howell Harte A, Nungesser R, Quigley N, Potter N.T, Weiss G, Koenig T, deVos T (2017) Uptake of a colorectal cancer screening blood test is higher than of a fecal test offered in clinic: A randomized trial Cancer Treatment and Research Communications. 10: 27–31

PRESEPT Trial. New Legislation Introduced for Blood Based Testing for Colorectal Cancer Screening

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).

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 Geneuity, 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.”

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

Geneuity Evaluates illumina TruSight® Tumor 15

Dr. Jamie Platt, Vice President of Genomic Solutions at Geneuity and Molecular Pathology Laboratory Network, Inc., evaluated the illumina TruSight® Tumor 15 and said the panel’s simplicity and ease of use makes it well-suited for translational labs, “The value and appeal of next-generation sequencing is the potential to consolidate traditionally iterative tumor analyses. Our evaluation of the new TruSight Tumor 15, with its streamlined library prep and sequencing workflow, gives us confidence that this application is ideal for deployment. Even our most challenging samples produced results, including those with low nucleic acid inputs, giving us assurance we can analyze our most precious specimens.”

Read illumina’s press release on Business Wire

Geneuity Presents at Biomarkers & Diagnostics World Congress 2015

Geneuity CRS and Molecular Pathology Laboratory Network Inc. Vice President Genomic Solutions Jamie Platt Ph.D., will be presenting at Biomarkers & Diagnostics World Congress 2015 in Philadelphia PA. May 7th . Dr. Platt will present on ‘Opportunities and Challenges for NGS-Based Clinical Trials’. Key challenges in NGS-based clinical trials will be discussed, and opportunities around assay validation, companion diagnostics, data analysis, genomic annotation and supporting services will be highlighted.

Continue Reading…

MPLN / Geneuity contributes to FDA approval of the Panther(TM) System

MPLN, through it’s Geneuity Clinical Research Services Division, participated in the instrument performance evaluations that contributed to the FDA approval of the Panther(TM) system for use with the APTIMA 2 Combo assay, particularly testing for the common sexually transmitted infections Chlamydia trachomatis andNeisseria gonorrhoeae. “It is a credit to the scores of talented and dedicated scientists and engineers who made it happen.  We believe that PANTHER will continue that revolution by bringing the power of fully-automated, sample to result capabilities to low- and medium- volume labs.,” said Carl Hull, Gene-Probe’s chairman and chief executive officer.

Dr. Nicholas Potter appointed to the medical advisory board of Epigenomics AG

Dr. Nicholas T. Potter has been appointed to the Medical Advisory Board of Epigenomics AG, a molecular diagnostics company developing and commercializing tests for the screening and diagnosis of cancer.  Their lead product Epi proColon 2.0, a blood-based test for the early detection of colorectal cancer (CRC) which is currently marketed in Europe and in development in the US, was recently used  to support a pivotal clinical trial for CRC detection and will be submitted to the FDA for approval later this year.  He is currently the Chief Scientific Officer and Director of Molecular Diagnostics at Molecular Pathology Laboratory Network, Inc., in Maryville TN.

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