Companion Diagnostics

CLIA-certified, CAP-accredited

Our team of experienced project managers is available to assist our partners by developing companion diagnostics in a CLIA-certified, CAP-accredited diagnostic laboratory.

Contact us. We will evaluate your program to determine if ARUP can support your successful FDA submission.


From early development to FDA approval, we've got you covered.

The Pharma Services group is ready to partner with you to develop companion diagnostics in any phase of your therapeutic program.

Our Pharma Services developed, validated, and submitted to the FDA the first companion diagnostic tests to receive approval under the HDE program. This work included establishing a design control program that enables ARUP to meet 21 CFR part 820 regulations.

  • KIT D816V for Gleevec eligibility
  • PDGFRB FISH for Gleevec eligibility

We have extensive experience in conducting FDA presubmission meetings, FDA module preparation and submission for devices, study risk determination, and securing CE marking.


Why partner with ARUP Laboratories?

  • ARUP’s team of experts work with our partners to determine patient eligibility for clinical trials and effectiveness of new therapeutics.
  • We offer a full suite of anatomic pathology testing services including IHC, FISH, and genotyping.
  • Our partners have access to 90 nationally and internationally recognized medical directors, including experts in hematopathology and molecular oncology.
  • Our diagnostic test results and their interpretation by our anatomic pathologists are used by our partners to secure FDA approval of new therapeutics in oncology.

Central Pathology Review

World experts in rare disease pathology.

We're dedicated to the success of your new therapeutic submission.
Committed to testing and expert interpretation ensuring the right patients are receiving your therapy.

Contact us. We can assist with your project to ensure the highest probability of success.


Academic Research

Born out of academics.

Unparalleled attention to detail and robust quality systems will lend to the success of your academic research project.

Contact us. We are your trusted partner for academic research collaborations.


ARUP Laboratories understands the role of academic research in the advancement of medicine.

Non-profit enterprise of the University of Utah and its Department of Pathology.

Our Team of medical directors are faculty in the University of Utah’s Department of Pathology and make significant contributions in research and development.

Our medical and technical staff author textbooks and journal articles, present lectures, workshops, and symposia at regional, national, and international meetings.