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June 29, 2023ARUP Laboratories has received FDA approval for its companion diagnostic immunoassay, AAV5 DetectCDx™, which helps determine patient eligibility for a new gene therapy for severe hemophilia A.
November 29, 2023ARUP believes the FDA’s plan to regulate lab-developed tests will limit access to testing, increase costs, and face a court challenge, and is calling for collaboration to better address LDT oversight.
October 2, 2023The FDA’s newly proposed rules would regulate all in vitro diagnostic products as medical devices if enacted. ARUP believes additional FDA oversight would disrupt the diagnostic testing market.
September 29, 2023New ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine™ will improve patient lives by advancing groundbreaking diagnostic and prognostic technologies.
June 12, 2023ARUP’s Clinical Trials and PharmaDx groups supported Blueprint Medicines’ clinical trials that led to FDA approval for AYVAKIT® (avapritinib), a new treatment for indolent systemic mastocytosis.
March 20, 2024ARUP’s new test, Alzheimer’s Disease Markers, CSF, will pave the way for more assays that help detect the disease soon enough to try therapy to slow its progression.
April 27, 2023ARUP’s Biochemical Genetics lab performs critical, complex testing to diagnose and monitor metabolic disorders. Every person in the laboratory plays a role in promptly delivering thorough results.
March 5, 2024Nearly 85% of respondents to an ARUP survey believe the FDA’s proposed rule to regulate lab-developed tests will negatively impact their labs. Only 3% believe they have the financial resources to
July 5, 2023The FDA now recommends the same assessment questions for all donors, regardless of gender or sexual orientation. ARUP Blood Services is one of the first donor centers to update processes in response.
January 10, 2024After wrapping up her education in plant biology, Dipanwita Banerjee, MS, took some time off to see the world and start a family. She later returned to the laboratory environment at ARUP.
August 22, 2023Forbes magazine has listed ARUP as one of the 2023 Best Employers by State based on employer recommendations from employees and others in Utah in a recent survey conducted by Statista.
August 15, 2023ARUP is gearing up for the launch of a new hematopathology webinar to be hosted by Madhu Menon, MD, PhD, FCAP. Other ARUP experts will join Menon to discuss timely issues in hematopathology testing.
December 1, 2023Utah Business magazine honored ARUP Laboratories with its Best Companies to Work For award for the sixth consecutive year based on anonymous employee survey results.
June 23, 2023Valerie Collier, MS, CGC, will present insights on the DEX MolDx program and how to submit Z-Code applications under new private payer Z-Code requirements as an expert panelist in an upcoming webinar.
May 1, 2023ARUP’s new test to detect Candida auris will offer a robust screening tool to help clinical facilities identify patients colonized with the yeast and guide infection prevention measures.
November 10, 2023A panel discussion at the Utah Life Sciences Summit explored how the FDA’s proposed rule to further regulate laboratory-developed tests could slow advances in diagnostic medicine.
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 will aid in determining the eligibility of non-U.S. patients for a new hemophilia A gene therapy.