The Challenge

A Midwestern diagnostic company desired to bring a DNA based diagnostic to market as an FDA approved medical device. The device would be cleared through the FDA PMA approach and would be the companies first FDA approved medical device. A parallel submission (FDA/CMS) would be utilized.  The technology represented an innovative, groundbreaking approach to identify colorectal cancer using a genetic based noninvasive test.

The diagnostic company needed to accomplish the qualification and validation of the facility/utility systems, functional test methods, production, and reagent formulation, dispensing, labeling, and kitting of the medical device. Performance Validation was retained to provide assistance with these tasks.

The Solution

Initial tasking included the development of the validation plans for the following subsystems associated with the production/testing facility:
• Facility / Utility
• Functional Test Methods
• Manufacturing and formulation
• Dispensing, Labeling, and kitting

To accomplish this task, Performance validation developed the validation program standard operating procedures for facility and utility qualification, change control, cleaning, and process validation.

On successful completion of SOP development, Performance Validation was retained to further assist in the development of the validation plans for each major manufacturing step in the production workflow, including the development of equipment IQ, OQ protocols, and process validation protocols. Additionally, Performance Validation provided consultancy services to the client to assist in providing a best-fit compliant solution for their validation program and project specific validation documents.

Finally, Performance Validation was retained to assist in developing the equipment qualification protocols that would be executed for the equipment used in performing the clinical trial assays at the trial sites.

The Results and Benefits

Qualification of the facility, equipment, and process validation was successfully completed on time and within the allowable budget. The diagnostic company submitted the PMA submission to the FDA for review.

  • In March 2014, the FDA advisory panel unanimously recommended approval of this diagnostic test.
  • The facility completed its FDA inspection with no findings or observations in July 2014.
  • FDA approval and CMS recommendation for national coverage determination was obtained in August 2014.

As reported in the FDA Press release “This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day,” said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS. “This parallel review represents unprecedented collaboration between the two agencies and industry and most importantly will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer.”

Launching of this non-invasive diagnostic is a game changer in the detection of colorectal cancer. Often considered the most preventable – but least prevented cancer. Approval of this diagnostic has the potential to improve compliance with colorectal screening. Thus, improving early detection and treatment, resulting in improved survivability of individuals identified with colorectal cancer.  Performance Validation is very pleased to have participated in this project.

For additional information please schedule a call with one of our subject matter experts. 

John Underwood
Vice President, Michigan Division Director

Performance Validation

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