C-Path to ease process for diagnostic-test OK

[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 — the evolving process of matching patients to specific treatments based on genetic data.

"We think this is a huge unmet need, and, by filling it, will create jobs in Arizona, but more importantly it will really break the logjam so that we can get personalized medicine available to people in a more reliable fashion," Woosley said.

Woosley pointed to institutions like United States Pharmacopeia (USP) and Underwriter Laboratories that have set standards in their industries and have seals of approval.

"We don't have an Underwriter Laboratories or USP for diagnostic tests," Woosley said. "So that's why we got a grant from SFAz to see if such an entity would be viable, and then start it in Arizona."

The new standards agency would take a product closer to final FDA approval by establishing performance standards for each test.

Initially, USDS is working closely with Ventana Medical Systems to establish standards for a diagnostic test the company has developed for lung cancer.

The business plan for United States Diagnostic Standards calls for a further $24 million in investment over the next five years for USDS to break even, Woosley said. He estimates it will be six to nine months before the facility is operating.

"It's not a business because if it started making a profit, people wouldn't value our seal of approval," he said.

The non-profit status of USDS and its neutrality are essential for companies and the FDA to trust the results it produces, according to Dr. Gary Greenburg, a program officer at SFAz.
Greenburg sees this new national lab as very important to Arizona because it will raise the profile of Arizona and Southern Arizona in the diagnostic and bioindustry community and hopefully spin off new technology as a result.

"SFAz believes that the USDS will also help attract high-wage professionals to Southern Arizona, as well as acting as a magnet to attract and foster diagnostic and biotechnology companies," Greenburg said in an e-mail.