LDT UPDATE W/STACI KEARNEY (ELEVATION STRATEGIC CONSULTING) Artwork

Beyond the Scope

Beyond The Scope, a new podcast by the Digital Pathology Association, focuses on hot topics in digital pathology. Co-hosts Dr. Giovanni Lujan (OSUWMC) and Dr. David Tulman (Instapath) converse with key opinion leaders in an engaging format discussing all of the new research, technology, and workflows emerging in digital pathology. Beyond The Scope aims to cover specific topics ranging from artificial intelligence to computational pathology, whole slide imaging to in/ex-vivo microscopy, regulation and commercialization, and more! For more information on the DPA, please visit https://digitalpathologyassociation.org/.

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Beyond the Scope

LDT UPDATE W/STACI KEARNEY (ELEVATION STRATEGIC CONSULTING)

June 17, 2024 • Digital Pathology Association • Season 4 • Episode 5

Staci Kearney PhD is the founder and CEO of Elevation Strategic Consulting, a firm that provides regulatory assistance to digital pathology companies. In May 2024, The FDA ruled that Laboratory Developed Tests (LDTs) will be regulated as medical devices with FDA oversight in the coming years. Staci joins for a special episode to break down the timeline for vendors to be compliant with the new rule and implications for digital pathology companies and laboratories.

Laboratory Developed Tests-Frequently Asked Questions-FDA

A forum to engage with the hosts and other listeners has been launched on the DPA website www.digitalpathologyassociation.org. DPA members may login to the DPA Collaborate hub (under the Resources tab) and join the Beyond The Scope community. All listeners are encouraged to use this forum to suggest future topics and guests, submit questions and corrections, and provide general feedback.