PharmaDx—Project Examples & Highlights

As part of the PharmaDx program, ARUP has developed and implemented an augmented quality management system, which meets FDA requirements for medical devices under 21 CFR part 820, for use with selected pharma-sponsored programs.

Under its design control program, PharmaDx has received FDA approval for two companion diagnostic tests for determining Gleevec eligibility in two oncology indications. These are the first laboratory-developed tests to be approved by the FDA under the Humanitarian Device Exemption (HDE) program for rare diseases.

Recent highlights of ARUP’s PharmaDx program include:

  • Introduction of new tests into the clinical laboratory
  • Infectious disease assay development and clinical testing
  • Two FDA approvals for laboratory-developed tests
  • Laboratory support for global vaccine study
  • Multiple projects in oncology
  • Multiple projects in rare metabolic diseases

Benefits of working with ARUP’s PharmaDx team:

  • Access to a sophisticated, fully automated clinical laboratory that offers one of the broadest test menus in the industry
  • Some of the best turnaround times available in the industry
  • CLIA-based quality system and flexibility to accommodate specialized quality and regulatory requirements upon request
  • Test development expertise, including assay development under design control in accordance with FDA regulations (21 CFR part 820)
  • Clinical resources, including 100 medical experts available for client consultation
  • Dedicated, experienced project management team
  • Culture of excellent customer service