LDTs: Global Regulatory Evolution

Five subject matter experts share their views and insights on the current regulatory landscape for LDTs

The debate over lab developed tests continues.

Lab developed tests (LDTs) play a crucial role in fighting diseases across the globe. And it is key for diagnostics laboratories to be able to innovate and offer efficient solutions to patients. With the transition to IVDR in Europe and the continued discussion about the FDA’s role in connection with LDTs in the US, the current regulatory LDT landscape is in flux. At the 2022 AACC Annual Meeting, Tecan sponsored a symposium on “Lab Developed Tests: Global Regulatory Evolution” covering different views and perspectives from key speakers on the status of lab developed testing.

Victoria Pratt, Ph.D., VP Molecular Diagnostics Quality Assessment at Optum Genomics, talks about the different needs of LDT stakeholders.

Melina Cimler, Ph.D., CEO and Founder of PandiaDx, shares her view from the perspective of test kit manufacturers. 

Randy Prebula, Partner at Hogan and Lovells, gives an overview on the latest status of LDT regulation in the US.

Dr. Heike Möhlig-Zuttermeister, VP Intelligence & Innovation IVD at RQM+, shares her insights on LDTs in the new IVDR environment.

Taunya Alexander, VP QARA Reagents and Consumables at Tecan, talks about challenges and her lessons learned in the IVDR transition.

The debate – Listen to the debate about LDTs featuring our five key speakers.

How to navigate the regulatory minefield?

With every new regulation or guideline comes uncertainty about how it will affect patients, laboratories and businesses. And if that wasn’t enough, each country, region and industry has its own set of rules and regulations that must be taken into consideration. Whether you operate in a mature or emerging market, regulations are constantly changing and becoming more detailed and specific. Get ahead of the regulatory challenge by collaborating with a knowledgeable and experienced partner that offers solutions and expertise to scale healthcare innovation globally.



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