C-Path to ease process for diagnostic-test OK

November 3, 2008

By hammersmith

[Source: Dan Sullivan, ARIZONA DAILY STAR] – The Tucson-based Critical Path Institute is working to create a standard-setting body to evaluate the performance of diagnostic medical tests before their submission to the U.S. Food and Drug Administration.

This project has been approved by the C-Path board of directors, and initial funding for the project has come from a $2.16 million grant from Science Foundation Arizona. U.S. Rep. Gabrielle Giffords, D-Ariz., has also backed appropriation of another $2 million in the 2009 fiscal year budget to supplement the grant from SFAz.

C-Path has hired PricewaterhouseCoopers to create a business plan for the new non-profit agency, and has received a federal trademark for its name, United States Diagnostic Standards.

This week, C-Path started approaching diagnostic companies to get commitments. The drug institute also is planning a new facility for the project and hiring employees.

To get a drug approved by the Food and Drug Administration, it may take 15 years and $1 billion, but the process is well-defined, according to Dr. Raymond Woosley, the president and CEO of C-Path. However, there is no such pathway for diagnostic tests, he said.

Companies like Ventana Medical Systems, which markets tests for cancer, have had difficulties getting these tests through the FDA system, Woosley said.

United States Diagnostic Standards, or USDS, will help streamline the process, filling a national need to advance the field of personalized medicine