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The U.S. Food and Drug Administration (FDA) has updated its blood donation guidelines to remove a former ban related to concern about variant Creutzfeldt-Jakob disease (vCJD) transmission.

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.

A woman collects a saliva sample, a specimen type validated for the COVID-19 molecular diagnostic test developed during the COVID-19 pandemic as a laboratory-developed test.

Jennifer (Jenna) Rychert, PhD, ARUP medical director of Operational Informatics and Microbial Immunology, and Jonathan Genzen, MD, PhD, ARUP chief medical officer, coauthored the report of the new study, “Laboratory-Developed Test Orders in an Academic Health System.”

Medical laboratory professionals such as this pair at work at ARUP are in high demand. The U.S. Bureau of Labor Statistics estimated that nearly 26,000 more of these highly trained specialists will be needed each year through 2030.

Founding members of the new Institute for Research and Innovation in Diagnostic and Precision Medicine^TM 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.

ARUP Laboratories has released the company’s public comment in response to the FDA’s plan to regulate LDTs.

ARUP President and Chief Scientific Officer Tracy I. George, MD, pioneered the central pathology review service that screens and confirms potential patient candidates for clinical trials and monitors their drug responses.

Nathan Boggs, MD, PhD, an assistant professor of medicine at the Uniformed Services University who is engaged in systemic mastocytosis (SM) translational research, helped Mark Withers, MD, obtain a definitive diagnosis of SM after 20-plus years. Tracy George, MD, ARUP Laboratories president and chief scientific officer, has led the effort to develop highly sensitive tests at ARUP that aid in the diagnosis of SM and has played a key role in clinical trials for emerging treatments.

ARUP Associate Medical Director Steven Baker, MD, PhD, will lead research that aims to determine whether gene therapies can be developed to treat patients living with creatine transporter deficiency (CTD).

Members of the Biochemical Genetics laboratory gather for a photo.

Stewart and Becky Tribe, shown here with their 2-year-old son Woodward and their 5-year-old daughter Linden, say their family benefitted greatly from newborn screening that led to their son’s early GAMT deficiency diagnosis. Woody, as he is called, has taken supplements since his birth that have prevented cognitive impairments he might have developed if the disorder had not been detected in infancy.

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.

ARUP Medical Laboratory Scientist Beah Manuel performs enzyme activity deficiency testing. Employer recommendations from employees like Manuel and others in Utah landed ARUP Laboratories a spot on Forbes Magazine’s most recent list of best employers by state.

Detection of Candida auris by polymerase chain reaction (PCR) will provide faster results to aid healthcare providers in their efforts to combat spread of the infectious fungus.

Dr. Madhu Menon, ARUP section chief of Hematopathology and host of a new Hematopathology Expert Series, will be joined by colleagues for a panel discussion following the first webinar of the series: “State of Hematopathology: The Past, Present, and the Future.”