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.
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™.
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.
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.