AAV5 logo

AAV5 DetectCDx™ detects the presence of anti-AAV5 antibodies to aid in the selection of patients eligible for the treatment ROCTAVIAN™.

November 10, 2023

EU Approval of AAV5 DetectCDx™ Provides Access to Companion Diagnostic for Hemophilia A Gene Therapy

ARUP has gained a Conformité Européenne (CE) mark for AAV5 DetectCDx™ single-site use. The test

Dave Shiembob speaks to a group of people

Dave Shiembob, manager of ARUP Healthcare Advisory Services, guides clients with utilization best practices and real-time opportunities.

October 10, 2023

ARUP Healthcare Advisory Services Wins a Third ASCP Choosing Wisely Champion Award

A platform clients use to reduce testing waste, lower cost per test, and improve patient safety has

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Founding members of the new Institute for Research and Innovation in Diagnostic and Precision MedicineTM gather. In the back row, from left to right, are David P. Ng, MD; Hunter Best, PhD, FACMG; Tracy George, MD; Leo Lin, MD, PhD; and Brendan O’Fallon. In the front row, from left to right, are Salika M. Shakir, PhD, D(ABMM); Robert S. Ohgami, MD, PhD, FCAP; Benjamin Bradley, MD, PhD; and Erica Clyde. Not pictured: Tatiana Yuzyuk, PhD, ABMGG; Evan Raps, MD; Peng Li, MD, PhD; and Valarie McMurtry, MD, PhD.

September 29, 2023

ARUP’s New Institute for Research and Innovation in Diagnostic and Precision Medicine™…

New ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™ will

An individual is being prepped to donate blood

ARUP Blood Services has aligned its donor eligibility assessment processes to follow recent U.S. Food and Drug Administration (FDA) guideline updates, and the changes will take effect on July 18, 2023.

July 5, 2023

ARUP Blood Services Implements Changes in Response to New FDA Guidelines on Blood Donor…

The FDA now recommends the same assessment questions for all donors, regardless of gender or sexual

AAV5 DetectCDx™

ARUP’s new test is the first companion diagnostic immunoassay for a gene therapy product to receive FDA approval. FDA has issued simultaneous approval of ROCTAVIAN™ (valoctocogene roxaparvovec-rvox), BioMarin’s gene therapy for severe hemophilia A.

June 29, 2023

FDA Approves ARUP Laboratories’ AAV5 DetectCDx™, a First-Ever Companion Diagnostic Immunoassay for a Gene…

ARUP Laboratories has received FDA approval for its companion diagnostic immunoassay, AAV5

A clinician works at a computer

April 12, 2023

ARUP Laboratories Chooses Gestalt’s PathFlow Solution for Its Strategic…

ARUP and Gestalt Diagnostics announced a partnership under which ARUP will adopt Gestalt’s