Media Contact
Leah Westover
AVP, Product & Market Strategy
The FDA's phased plan to regulate Laboratory Developed Tests (LDTs) faces significant legal challenges. Stakeholders are raising concerns over the FDA’s authority, particularly post-Chevron Doctrine reversal, which limits agency deference. The outcome of these legal battles could reshape the LDT landscape and influence how laboratories approach compliance.
About Vastian
Founded in 1995, Vastian provides the leading SaaS-based quality management software for clinical laboratories and hospitals in the country. We offer support for more than 5,000 healthcare facilities in all 50 states, 50 countries, all 7 continents, and over 500,000 clinical professionals each year. With our proprietary platform, we provide a full suite of solutions from document and compliance management to enterprise and individual education and CEUs, as well as readiness assessments to ensure preparedness for compliance agency regulations and certification. Vastian is a private equity backed, fast-growing business based in Lawrenceville, GA, outside Atlanta.