Navigating FDA Regulations and AI in Genetic Testing with Yuriy Shevchenko

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Navigating FDA Regulations and AI in Genetic Testing with Yuriy Shevchenko

August 9, 2024

How do you bridge the gap between scientific innovation and regulatory compliance in the ever-evolving field of genetics? There’s no better expert to answer this question than LEAP's own Yuriy Shevchenko, PhD who spends his days helping labs with all of their needs operationalizing and auotmating clinical and biopharma assays, moving from R&D to commercial launch, improving assay designs, reducing TAT, automating, and reducing failures. 

In this Connected Conversation by Ad Astra hosted by Elena Petrova, Yuriy discusses:

  • The implications of the latest FDA Final Rule about LDTs and the discussion about whether the FDA should even be regulating them at all.

  • The communication challenges between government agencies, the scientific community, and business entities.

  • The future of genetic testing and the role of AI in enhancing but not replacing the human touch in clinical diagnostics.

  • The importance of patient safety and the need for qualified professionals to review AI-generated results.

  • The impact of the COVID-19 pandemic on genetic testing and the surge in demand.

You’ll also hear about Yuriy’s background of over 20 years of expertise in genetic diagnostics and his journey to the forefront of designing clinical diagnostic assays and creating automated, high-throughput lab workflows under CLIA/CAP/NYSDOH/FDA regulations.

After you watch this interview, if you’d like to find out how Yuriy and LEAP can help your organization with LIMS, Bioinformatics, or Lab Automation, let’s talk.

For more information on how LEAP can help your organization get ready to meet the FDA enforcement phase-in, click here.

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LEAP Consulting Group Launches Practice to Support Clinical Labs through Compliance with the FDA Final Rule on LDT Enforcement