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

ARUP’s Capabilities

• Developing novel, single-site CDx under design control in accordance with 21 CFR part 820
• Submitting Humanitarian Use Device (HUD), Study Risk Determination (SRD), Investigational Device Exemption (IDE), and Humanitarian Device Exemption/Premarket Approval (HDE/PMA) FDA filings
• Interacting with U.S. and global regulatory bodies
• Handling CE (Conformitè Europëenne) marking of tests
• Coordinating CDx projects that involve a range of different assay types
• Facilitating collaboration with ARUP’s subject matter experts
• Offering CDx testing at ARUP in the commercial setting for the life of the approved therapeutic

ARUP’s Pharma Services team developed, validated, and submitted the first CDx tests to receive approval from the U.S. Food and Drug Administration (FDA) under the Humanitarian Device Exemption (HDE) program.

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

This work included establishing a design control program that enables ARUP to meet 21 CFR part 820 regulations.

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

Our Pharma Services team also has considerable experience in developing immunoassays as CDx for the detection of preexisting antibodies to gene therapy vectors.
Read more about ARUP’s experience in CDx development for gene therapy..

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

Email companiondiagnostics@aruplab.com to get started.