At ARUP Laboratories, we pride ourselves on discovering and sharing solutions to the myriad challenges our hospital and health system partners face. 

So it should come as no surprise that when the FDA earlier this year published its long-anticipated and far-reaching new rule regulating laboratory-developed tests (LDTs) as medical devices, ARUP was at the forefront, unraveling the contents and implications of the 500-page rule so that we can help our clients thoughtfully and strategically adopt the new regulation while continuing to prioritize patient care.

Fortunately, ARUP’s chief medical officer and senior director of governmental affairs, Jonathan Genzen, MD, PhD, MBA, has spent the past decade gaining substantial expertise and understanding of attempts by the FDA and the U.S. Congress to place new regulation on LDTs. Dr. Genzen has earned well-deserved respect in the clinical laboratory industry, not only as a knowledgeable and generous educator, but as an impassioned advocate for the tens of thousands of laboratory scientists who have committed their careers to the practice of high-quality, caring laboratory medicine.

You will hear Dr. Genzen’s voice throughout this edition of Magnify, which aims to help make sense of the new FDA rule. He has published research, written articles, and appeared on numerous webinars and in podcasts that are available at aruplab.com. In the pages of this issue, you will find his carefully crafted and continually updated matrix of the requirements that labs will have to comply with, as well as a timeline that spells out each stage of the rule’s implementation in the coming years. Drawing on Dr. Genzen’s expertise, ARUP will continue to share knowledge and guidance when or if the landscape around the new rule shifts. Many of you know, for example, that a lawsuit challenging the FDA’s authority to regulate LDTs is wending its way through the courts even as the new Trump administration may act to rescind the rule.

Hospitals and health systems that partner with ARUP know they can count on us to support them in any way possible so that they can support their patients. We’ll continue to make good on that promise.