# Part 2: The Theranos Loophole & Lab Developed Tests

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-02-16
- Length: 43m
- Episode: 306
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests
- Listen: https://podcast.greenlight.guru/episode/part-2-the-theranos-loophole-lab-developed-tests

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests#t=0) Introduction and Recap of LDT Regulation
- [4:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests#t=292) Risk Assessment: LDTs vs IVDs and Cancer Diagnostics
- [14:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests#t=842) The Theranos Loophole and Liberal Interpretation of LDTs
- [20:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests#t=1251) Contingency Planning and LDT Justification Documents
- [26:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests#t=1611) Criteria for Legitimate LDTs: Labeling, Technology, and Risk
- [36:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests#t=2204) Proposed Regulatory Solutions: IRB Oversight and New FDA Center

## Topics

- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Theranos (company)
- VALID Act (other)
- Clea (other)
- FDA (other)
- Greenlight Guru (company)

## Related episodes from other shows

- [154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-18-154-ivds-ldts-companion-diagnostics-precision-medicine-clinical-validation-bioma) (Let's Combinate)
- [Theranos, Silicon Valley, and the March Madness of Tech Fraud](https://hardwarepodcasts.com/podcast/oxide-and-friends/2021-09-21-theranos-silicon-valley-and-the-march-madness-of-tech-fraud) (Oxide and Friends)
- [216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou) (Let's Combinate)
- [074: Medical Device Product Development Best Practices](https://hardwarepodcasts.com/podcast/product-startup/2021-05-05-074-medical-device-product-development-best-practices) (Product Startup)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-16-part-2-the-theranos-loophole-lab-developed-tests. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.