AdvaMed Statement on the Release of FDA Rule on Laboratory-Developed Tests

AdvaMed logo

WASHINGTON, D.C. –  Today, AdvaMed, the Medtech Association, released the following statements from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s final rule for Laboratory Developed Tests (LDTs):

“We appreciate FDA’s commitment to ensuring the safety and effectiveness of in vitro diagnostic tests, regardless of their source, which is what today’s rule would accomplish,” Whitaker said. “We hope this rule is just the first step toward comprehensive reform of the framework for diagnostic test regulation overall, which the VALID Act would accomplish through Congress. This reform is critical to supporting the continued innovation of safe, effective, and high-quality diagnostic tests.”

“This rule represents significant progress in ensuring that diagnostic tests, regardless of where they were developed, meet FDA’s rigorous standards for safety and effectiveness,” Rothstein said. “We also encourage Congress to pass the bipartisan VALID Act, which would establish a modernized, diagnostics-specific regulatory framework for all diagnostics tests. We remain committed to advocating for this important legislation and we look forward to continuing our collaboration with Congress and all stakeholders in these efforts.”

###

Education And Opportunity Mark Strength Of Atlanta Biotech Industry

March 13, 2026
A skilled workforce is the engine that will drive growth across America’s biotechnology industry, and Atlanta has built multi-faceted training programs that are developing and sustaining the talent pipeline for everything from advanced laboratory research to industrial biomanufacturing.

Growing Georgia Biomanufacturing Industry Transforming American Industrial Strength

March 12, 2026
On March 12, 2026, Augusta, Georgia served as the setting for an important conversation about the future of American biotechnology and manufacturing. Manus welcomed members of the U.S. National Security Commission on Emerging Biotechnology (NSCEB) to its Augusta BioFacility to highlight how advanced biomanufacturing is strengthening U.S. supply chain resilience and supporting the growing bioeconomy. During the visit, Manus unveiled a significant expansion of its 44-acre Augusta BioFacility, increasing domestic capacity to produce critical biobased ingredients. The expansion further positions Georgia as a key hub for advanced biomanufacturing and demonstrates the growing role of biotechnology in strengthening national economic and supply chain security. Commission members met with leaders from industry, government, and academia to discuss strategies for scaling manufacturing infrastructure, strengthening resilient supply chains, and preparing the workforce needed to support the next generation of the U.S. bioeconomy. The visit also included conversations with Manus employees about the practical realities of building and operating advanced biomanufacturing facilities in the United States. The Augusta site has become one of the largest advanced biomanufacturing facilities in the country, producing a growing portfolio of bioalternatives at industrial scale. Among these products is high-purity Reb M, recently launched as Yume™ M Stevia Sweetener , supported by an all-Americas supply chain. “As we scale the Manus bioalternatives platform, Augusta has become a powerful example of what the modern U.S. bioeconomy looks like in practice,” said Manus Founder and CEO Ajikumar Parayil. The visit underscores Georgia’s expanding leadership in life sciences manufacturing and highlights how regional ecosystems can help advance U.S. leadership in biotechnology and biomanufacturing. Learn more about the expansion and visit: Manus welcomes U.S. National Security Commission on Emerging Biotechnology to unveil major Augusta BioFacility expansion Growing Georgia Biomanufacturing Industry Transforming American Industrial Strength

GLS Advocacy Success: HB 139 Tabled Ahead of Crossover

March 6, 2026
Message from CEO
MORE POSTS