Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Green Park Collaborative to Develop Evidence Standards for Next Generation Sequencing-Based Testing in Oncology

January 13, 2014 By the Associated Press

The Green Park Collaborative (GPC-USA), sponsored by the Center for Medical Technology Policy (CMTP), today launched a new effort to develop methodological guidance on the kinds of evidence needed to evaluate promising tests in the rapidly developing field of Next Generation Sequencing (NGS) for cancer diagnosis and treatment.

NGS streamlines the technical aspects of molecular testing for a variety of diseases while producing higher volumes and breadth of genomic information, at increasingly competitive costs. When applied in oncology, NGS promises to accelerate our growing understanding of cancer, helping to define tumors’ biological pathways and genetic characteristics. It is yielding a much more accurate picture of diseases and making possible a new generation of targeted therapies.

Assessing the clinical utility of these innovations, however, remains challenging.

“The rapid development of NGS-based tests for use in oncology has highlighted this technology’s tremendous potential to improve clinical care and patient outcomes,” said Sean Tunis, MD, MSc, President and CEO of CMTP. “At the same time, it underscores the need for a clearly defined, consistent and broadly accepted framework for evaluating the evidence of the clinical utility of tests in well-designed, feasible studies.” Providing needed methodological guidance This 2014 initiative, organized within the GPC’s existing Oncology Consortium (see below), will produce an Effectiveness Guidance Document (EGD) designed to inform evidence-based decision making regarding coverage and reimbursement for NGS-based tests. The work will be directed by Elisabeth Houtsmuller, PhD, senior program director for GPC, and driven by a technical working group that will include expert representatives from health plans, CMS, NGS test developers, FDA, patient groups, oncology guideline organizations, clinical oncologists, drug/biologic companies, and other groups with a direct interest in NGS in oncology.

The project’s EGD will focus on NGS-based tests used to manage patients with a known diagnosis of cancer (as opposed to risk prediction testing). Its recommendations will be aligned with existing and emerging regulatory guidance where relevant. This effort will be informed by CMTP’s recent work on evidentiary standards for studies of the clinical validity and clinical utility of molecular diagnostics in oncology.

“The kind of guidance this process is developing will be invaluable,” said Elaine Jeter, MD, Medical Director of Palmetto, GBA, a Medicare Administrative Contractor and the developer of the MolDx program.

“There is tremendous promise surrounding Next Generation Sequencing technologies, but we need guidance to help us evaluate the quality of the evidence supporting these tests and in turn guide test makers in their efforts to demonstrate these products’ clinical utility.” The GPC’s Oncology Consortium is also developing an EGD and associated methodologic recommendations and data strategies to help shape research on the best ways to sequence cancer care treatments.  This work is led by Donna Messner, PhD, Research Director at CMTP, and Anne Schott, MD, who specializes in medical oncology at the University of Michigan.  Dr. Schott is chairing the Technical Working Group responsible for developing initial recommendations for the guidance document.

Related Articles Read More >

A photo of Capstan Medical's mitral valve implant, which uses nitinol.
Capstan Medical’s R&D head discusses the heart valve and robotics startup’s tech, engineering challenges and solutions, advice for others in medtech and how to join his team
An illustration of a neurosurgeon using a robotic endoscope to remove a brain tumor.
MDO Nitinol Innovation Special Report
A photo of Highridge Medical CEO Rebecca Whitney.
Highridge Medical is betting on this spine tech
A photo of the miniature Auxilium Biotechnologies implants made on the International Space Station.
Implants 3D-printed in space could enable nerve regeneration
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe