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The U.S. District Court for the Eastern District of Texas in Plano on Wednesday heard oral arguments on motions for summary judgment in a legal challenge of the FDA’s authority to regulate laboratory-developed tests.

ARUP Laboratories has filed a declaration supporting a lawsuit against the FDA brought by the American Clinical Laboratory Association.

The U.S. District Court for the Eastern District of Texas today struck down the FDA’s final rule to regulate laboratory-developed tests.

Digitally colorized transmission electron microscopic image of avian influenza A (H5N1) virus particles (in gold), grown in Madin-Darby canine kidney (MDCK) epithelial cells (in green).

ARUP’s new assay, Influenza A (H5) Virus by Qualitative NAAT (ARUP test number 3018970), will expand the national capacity to detect the current outbreak of highly pathogenic avian influenza A (H5N1).

Representative Blake Moore (R-Utah, District 1) speaks during a House Committee on Ways and Means hearing held at ARUP Laboratories. Pictured from left to right are Celeste Maloy (R-Utah, District 2), Burgess Owens (R-Utah, District 4), Moore, Jason Smith (R-Missouri, District 8), and Brad Wenstrup, MD (R-Ohio, District 2).

The robotic arm removes the wet-mount specimen slide in preparation for scanning. Once scanned, the image will be screened via artificial intelligence (AI) for evidence of ova and parasites.

Fallon Williams, left, pictured with her son, Zay, daughter, Eko, and husband, Bashaun.

Susan Driggs, a medical laboratory scientist in ARUP’s University of Utah Hospital Clinical Laboratory, has worked in the same lab since the 1970s, before ARUP was founded.

A new test that ARUP offers for preeclampsia risk measures the ratio between two angiogenic factors (sFlt-1 and PlGF) that are produced by the placenta and are involved in the pathophysiology of preeclampsia.

Karen Brisendine currently works as a technologist in ARUP’s Mycology Acid-Fast Bacilli (AFB) Lab, but she has worked in many departments at ARUP since she started with the company at its founding in 1984. Along the way, she has learned more about herself and discovered a passion for laboratory science.

The partnership combines Tasso’s clinical grade blood collection solutions, such as the Tasso+ device pictured above, with ARUP’s gold standard testing capabilities to streamline and accelerate decentralized clinical research.

Rep. Blake Moore (R-UT) and other members of the Ways and Means Committee’s Health Subcommittee will participate in a field hearing on July 12 at ARUP Laboratories.

Jonathan Genzen, MD, PhD, MBA, ARUP’s chief medical officer and senior director of governmental affairs, along with three coauthors, created a detailed resource summarizing existing federal laws and regulations in the context of anatomic pathology.

The biomarker pTau 217 is associated with Alzheimer’s disease pathology and can be detected in plasma, providing a minimally invasive option to support other diagnostic tests.

Jonathan Genzen, MD, PhD, ARUP’s chief medical officer and senior director of governmental affairs, and Jonathan Carr, JD, chief compliance officer, discuss the FDA’s final rule on LDTs.

The research grant is named in honor of retired ARUP CEO Sherrie Perkins, MD, PhD, whose leadership laid the groundwork for ARUP’s increased focus on innovation.

The Tasso+ self-collection device can be shipped directly to patients, facilitating remote collection of whole blood samples and eliminating the need for lab visits.