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Jonathan Genzen, MD, PhD (left), chief medical officer and senior director of governmental affairs, and Jonathan Carr, JD (right), compliance officer, prepare for ARUP’s webinar on the FDA’s proposed rule to regulate lab-developed tests. |
November 30, 2023 |
Watch Now: ARUP Experts Host Q&A Session on FDA’s Proposal to Regulate Lab-Developed Tests Days before the public comment period ends, ARUP Laboratories’ experts host webinar to educate and encourage attendees to provide comments on the FDA’s proposed rule to regulate lab-developed tests. |
ARUP Laboratories has released the company’s public comment in response to the FDA’s plan to regulate LDTs. |
November 29, 2023 |
ARUP Laboratories Urges FDA to Withdraw Proposed Rule Regulating Laboratory-Developed Tests ARUP 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. |
Jonathan Genzen, MD, PhD (left), chief medical officer and senior director of governmental affairs, will lead the webinar, and Jonathan Carr, JD (right), compliance officer, will moderate a Q&A session. |
November 21, 2023 |
ARUP to Host Webinar to Discuss Impacts of the FDA’s Proposed Rule to Regulate Lab-Developed Tests ARUP experts seek to increase understanding of the FDA’s proposed rule to regulate lab-developed tests as medical devices and the impact on hospitals and patients during a webinar on November 29. |
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 will aid in determining the eligibility of non-U.S. patients for a new hemophilia A gene therapy. |
From left, Greg Critchfield, Myriad Genetics and Sera Prognostics; Mark Poritz, Co-Diagnostics; Kyle Berg, Quansys Biosciences; Jared Bauer, Seek Labs; Tracy I. George, ARUP Laboratories; and Andrew Hemmert, bioMerieux. These panelists addressed challenges facing diagnostics companies during a discussion at the Utah Life Sciences Summit in Salt Lake City on November 9. |
November 10, 2023 | A 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. |
Founding members of the new Institute for Research and Innovation in Diagnostic and Precision MedicineTM collaborate. From left, Erica Clyde, MBA; Robert S. Ohgami, MD, PhD, FCAP; and Hunter Best, PhD, FACMG. |
November 9, 2023 |
ARUP to Highlight Molecular Pathology Advances at Annual Association for Molecular Pathology Meeting ARUP experts in molecular pathology will present at, participate in, and be available to attendees during the upcoming Association for Molecular Pathology (AMP) Meeting and Expo in Salt Lake City. |
ARUP Institute for Research and Innovation in Diagnostic and Precision Medicine We accelerate groundbreaking diagnostic and prognostic technologies to drive life-changing innovation. Our large, single-site operation and renowned quality framework, combined with our extensive expertise, provide an ideal incubator to advance custom projects for innovative partners. The Sherrie Perkins Research and Innovation Collaboration Grant The Sherrie Perkins Research and Innovation Collaboration Grant funds cutting-edge research in laboratory medicine.
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