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.
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
May 30, 2024ARUP’s declaration amplifies the lawsuit’s claims that the FDA does not have legal authority over laboratory testing services and that regulating these services is unreasonable.
April 24, 2024A new partnership between ARUP and connectivity provider ELLKAY aims to give health systems the testing support, guidance, and technology needed to establish or expand lab outreach operations.
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.
November 10, 2023ARUP 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.
March 21, 2024The FDA’s proposed rule to regulate lab-developed tests will force labs to halt essential testing, harming children and patients with cancer and rare diseases, says ARUP’s Jonathan Genzen, MD, PhD.