Hardware Podcasts

Part 2: The Theranos Loophole & Lab Developed Tests

Global Medical Device Podcast · 16 Feb 2023 · 43m · Episode 306

What this episode covers

Mike Drues, president of Vascular Sciences, discusses the regulatory loopholes surrounding Lab Developed Tests (LDTs) and their relation to the Theranos scandal, arguing that LDTs are not inherently low-risk and require rigorous engineering. He advises companies to create LDT justification documents and contingency plans to prepare for potential FDA regulation under the VALID Act. Drues proposes specific criteria for legitimate LDTs, including labeling restrictions, technology complexity limits, and risk assessments, while suggesting an EUA-like pathway or a dedicated Center for Diagnostics at the FDA to balance oversight with innovation.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Theranos, Greenlight Guru
Also
VALID Act, Clea, FDA

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