LabMind

As of September 2024, there remains enormous uncertainty about the FDA’s final rule on laboratory-developed tests (LDTs). Will it hold up in court? Which tests are subject to which requirements? How can laboratories best prepare? In this interview, Dr. Jonathan Genzen, ARUP’s chief medical officer and senior director of governmental affairs, responds to questions sent in by members of the laboratory community. 

Related Information: 

• ARUP Resources on the FDA’s Final Rule on Laboratory-Developed Tests (https://www.aruplab.com/fda-ldt-final-rule)
• ARUP Webinar--The FDA’s Final Rule on LDTs: What You Need To Know (https://youtu.be/nGQ3sRfWkBg)
• ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests (https://www.aruplab.com/news/05-30-2024/arup-files-declaration-support-lawsuit-challenging-fdas-rule) 
• FDA email address for questions on the final rule: ([email protected])

Fixing American healthcare will require more than mere tweaks around the edges. Dr. Vikas Saini, president of the Boston-based Lown Institute, believes that it will require a return to medicine’s humanist roots. In this interview he describes some of the ways in which many healthcare organizations prioritize revenue and profit over patients and communities. He also explains why he remains optimistic that Hippocratic principles will ultimately prevail. 

Related Information: 

• Lown Institute (https://lowninstitute.org/)
• 2024 Top Hospitals: America’s Most Socially Responsible Hospitals (https://lownhospitalsindex.org/the-most-socially-responsible-hospitals-in-the-u-s-2024/)
• 2023 Shkreli Awards: The Lown Institute’s Top Ten List of the Worst Examples of Profiteering and Dysfunction in Healthcare (https://lowninstitute.org/projects/2023-shkreli-awards/)

Clinical laboratories offer great careers, but lack of awareness and other barriers can prevent excellent candidates from pursuing laboratory science professions. In this interview, Isak Schmidley, MLS(ASCP), explains how he first stumbled across medical laboratory science while attending community college in his early teens and then persevered past age stereotypes to land his first hospital laboratory job at the impressive age of 16. He shares advice for laboratory leaders on what his generation expects from employers and tips on how to recruit the next generation. 

Most hereditary cancers, including those associated with BRCA1 mutations and Lynch syndrome, can be prevented through a combination of genetic testing, surveillance, and surgery. Yet only a small minority of eligible individuals currently receive this lifesaving intervention. In this interview, Dr. Brian Shirts, director of the Institute for Public Health Genetics at the University of Washington, discusses a new nonprofit organization that uses family connections to identify individuals at high risk for hereditary cancers and other adult-onset hereditary diseases. 
connectmyvariant.org 
#connectmyvariant 

Due to genetic variation, patients metabolize and respond to medications in vastly different ways, so why do most drug therapy regimens continue to be one-size-fits-all? In this interview, Dr. Yuan Ji, ARUP’s section chief of Molecular Genetics and Genomics, discusses how currently available genetic tests can be used to improve both the safety and effectiveness of pharmacotherapy.

Related Content:
Current Clinical Pharmacogenomic Testing: How Do Clinical Laboratories Stay on Top of Changes to Technologies, Professional Guidelines, and Regulations?   https://arup.utah.edu/education/ji-pharmtest-2024.php