Fluoride Action Network

WMIS Launches Clinical Trials for Sodium Fluoride (F-18) for CMS

Source: Digital Journal | November 30th, 2011 | Press Release
Industry type: Pharmaceuticals

With the success of the World Molecular Imaging Society’s (WMIS) initiative in helping obtain the FDA approval for Sodium Fluoride F18 injection, WMIS is now launching critical clinical trials to secure fair and meaningful reimbursement for this procedure. Successful clinical trials for reimbursement are necessary to ensure the feasibility and market acceptance for this diagnostic test.

The completion of the WMIS-led clinical trial, which has enrolled more than 325 patients, is a necessary CMS prerequisite prior to inclusion of sodium fluoride F 18 as a covered diagnostic positron emission tomography (PET) and PET/computed tomography (CT) clinical service for patients. A nuclear medicine imaging technique that produces a 3-D image or picture of biological processes in the body, PET is used to diagnose and improve patient management in diseases such as cancer, heart disease and neurologic disorders.

Leading companies in the industry such as IBA Molecular North America Inc., PETNET Solutions, Inc., a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., GE, and Triad are helping to support WMIS in this initiative.

Results from this WMIS trial and the National Oncologic PET Registry (NOPR) for sodium fluoride are required by the Centers for Medicare and Medicaid Services (CMS) to enable a broad coverage decision.

“With great partners such as IBA Molecular North America Inc., PETNET Solutions, GE, and Triad – we are transforming the competitive dynamics of the industry and WMIS is proud to facilitate industry-wide collaboration to deliver profound innovations” said WMIS’s President Dr. Juri Gelovani. “The industry needed to transition into a positive and collaborative gear to overcome self-defeating inertia and to create a win-win for all stakeholders. WMIS is smashing the industry silos and leading the convergence.”

Commenting on this remarkable example of industry-wide collaboration, PETNET’s CEO Ian Turner said: “The participation of industry, NOPR collaboration and multi-site interest in this innovative research reinforces the commitment to advancing a new paradigm for molecular imaging. PETNET Solutions is proud of its participation in this collaborative effort to advance the knowledge of the inherent benefit offered with sodium fluoride F 18 bone imaging relative to existing technology.”

IBA Molecular North America Inc., another industry leader and critical partner in the initiative, has also committed significant resources and taken a leadership role to accelerate the success of the initiative.

WMIS anticipates conclusion of the trial in 2012. CMS broad coverage approval is expected after trial results and the NOPR registry data are collected and published.

About WMIS
The World Molecular Imaging Society is a progressive organization that builds the school of thought, scientific paradigms and clinical practices of Molecular Imaging to advance the growing field of Molecular Medicine. The Academy and its journal are involved in the various technologies of molecular imaging and multimodalities formed by merging together imaging of biological processes with imaging anatomical structures within which these processes take place. This includes such technologies as PET, optical imaging, MRI, SPECT, CT and ultrasound. WMIS is the sponsor for the National Oncologic PET Registry (NOPR). To learn more about WMIS or to become a member, please visit the website at http://www.wmis.org.


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