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

MPLN Expands Immunohistochemistry with PD-L1

Geneuity a subsidiary of Molecular Pathology Laboratory Network Inc. launches Ventana PD-L1 and PD-1 assays, expanding their oncology immunohistochemistry menu of tests for NSCLC and other tumor types. MPLN’s repertoire of integrated testing now includes the addition of two new immunohistochemistry markers: VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody and VENTANA PD-1 (NAT105) Mouse Monoclonal Antibody.

PD-L1 by immunohistochemistry is indicated as an aid in the assessment of PD-L1 expression in non-small cell lung cancer (NSCLC) and other tumor types. Assessment of tumor PD-L1 protein levels may have prognostic and/or therapeutic significance in some cancer patients. Specifically, identifying PD-L1 expression on tumor cells may help determine which patients will most benefit from anti-PD-1/PD-L1 therapy.

The VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody (VENTANA PD-L1 (SP263)) is a rabbit monoclonal primary antibody directed against the programmed deathligand1 (PD-L1) B7 homolog 1 (B7-H1, CD274). The antibody detects the extracellular domain of PD-L1 and produces membranous and/or cytoplasmic staining.

PD-1 by immunohistochemistry detects the immune regulatory molecule programmed death-1 (PD-1) and has utility in both hematopathology diagnostics and in cancer biology. The programmed death-1 (PD-1) protein is expressed by follicular helper T-cells, and is useful in the diagnosis of hematolymphoid malignancies such as angioimmunoblastic T-cell lymphoma (AITL). In addition, clinical evidence suggests that IHC staining of the PD-1/PD-L1 pathway may have prognostic and/or therapeutic significance in some cancer patients.

MPLN selected the Ventana SP263 antibody as it complements existing laboratory platform and automation and has a simple single numerical cutoff value making interpretation more robust.


MPLN’s new LIS is launching June 20

MPLN LIS Blue v7.1.0 Ocean
Launch date June 20, 2016

Our next-generation laboratory information system (LIS) has been developed from the ground up to be fast, easy to use, accessible, and secure. MPLN has implemented the latest web technology to develop LIS Blue as a globally accessible browser-based web application.

LIS Blue delivers the same primary functionality as MPLN’s Indigo LIS. You can order tests, view reports, and check pending lists. The new interface is familiar and intuitive for those currently using MPLN’s Indigo LIS.

What makes it better?
Speed / Usability / Accessibility / Data Security

How do I start using it?
First, you will need a username and password. If you already have an account with MPLN Indigo LIS, it will carry over to the new system. If you require setting up a new account, contact client services at 865 380 9746

Next, you will need a modern desktop web browser. We recommend using the latest version of Google Chrome.

Install Chrome

Access LIS Blue:

What else do I need to know?
MPLN’s Indigo LIS will no longer be available once LIS Blue is live, and we want to make the transition as easy as possible for our valued customers. Our client service and technical support departments are available to help and have been working hard to make sure everyone is ready to make the switch.

Call client services or visit our help documentation for more info:
865 380 9746

Geneuity expands Next Generation Sequencing offering with Solid Tumor Panels

MARYVILLE, Tenn. – (Sept 17, 2015) – Geneuity and Molecular Pathology Laboratory Network (MPLN) today announced that it is expanding its integrated oncology specialty testing offering to include Next Generation Sequencing assays for solid tumor. The new panels will address Lung, Colon, Melanoma and an unknown primary 8 gene panel with soon to be released Gastrointestinal Stroma, Glioma, Ovarian, Renal and Thyroid solid tumor panels. Geneuity will be making the QIAGEN Human Tumor Actionable Mutations Panel available for clinical trial studies.

Continue Reading…

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 Next Generation Dx. Summit


Geneuity CRS and Molecular Pathology Laboratory Network Inc. Vice President Genomic Solutions Jamie Platt Ph.D., will be presenting at NextGenDx. Summit Washington DC. August 17th-20th 2015. Dr. Platt will present a short course on How Multi-Gene Panel and Exome Testing are Becoming New Diagnostic Standards for Inherited Disorders, Lead a problem solving discussion on NGS Annotation and Interpretation and present on NGS annotation in Genomics, Genetics, and RNA-SEQ with a review of the NGS Annotation Landscape for Genomics, Genetics, and RNA-Seq: Current Challenges for Commercial Clinical Labs.

Geneuity Presents at San Diego Medical Genomics Summit

Geneuity CRS and Molecular Pathology Laboratory Network Inc. Vice President Genomic Solutions Jamie Platt Ph.D., will be presenting at San Diego illumina Medical Genomics Summit June 8th 2015. Dr. Platt will present  “LDTs to NGS IVD Systems, a Customers Perspective” and discuss verification of the first FDA IVD use cleared MiSeqDx Next Generation Sequencing system. Dr. Platt will also highlight differences between Laboratory Developed Tests (LDT) and IVD assays in a CLIA environment and share experiences with the illumina IVD assay Cystic Fibrosis 139-Variant Assay (IVD).