# Part 1: The Theranos Loophole & Lab Developed Tests

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-02-10
- Length: 37m
- Episode: 305
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests
- Listen: https://podcast.greenlight.guru/episode/part-1-the-theranos-loophole-lab-developed-tests

## Summary

Mike Drues, president of Vascular Sciences, explains the regulatory distinction between Lab Developed Tests (LDTs) and In Vitro Diagnostics (IVDs), noting that LDTs are currently exempt from FDA pre-market review under the guise of the 'practice of medicine.' He argues that this loophole, highlighted by the Theranos case, allows companies to bypass rigorous safety and efficacy testing, creating a double standard where hospitals face no oversight for modifying commercial devices while manufacturers do. Drues emphasizes that the VALID Act, which would bring LDTs under FDA jurisdiction, has been stalled in Congress despite bipartisan support, leaving a significant regulatory gap that risks patient safety.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=0) Introduction: Mike Drues and Vascular Sciences
- [2:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=165) Defining IVDs and their FDA Regulation
- [9:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=548) The Definition and Regulatory Status of LDTs
- [13:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=816) The Theranos Loophole and Hospital Scope
- [19:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=1166) The VALID Act and Political Stalemate
- [24:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=1498) Why Labs Develop Tests and Modification Risks
- [27:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=1666) Risk Assessment: Non-Invasive High-Risk Devices
- [33:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests#t=2007) Future Outlook and Reactive Regulation

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Debugging & failure analysis](https://hardwarepodcasts.com/topic/debugging-and-failure-analysis)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Theranos (company)
- FDA (other)
- CDRH (other)
- CLIA (other)
- VALID Act (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)
- [043 - “Half Knowledge Can Hurt” with Shadeed Salam](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam) (Let's Combinate)
- [047 - "Truthful Not Misleading" with Darshan Kulkarni](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni) (Let's Combinate)
- [087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque](https://hardwarepodcasts.com/podcast/lets-combinate/2023-05-31-087-from-crime-reporting-to-regulatory-affairs-and-on-off-the-record-with-ferdou) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)

## 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/2023-02-10-part-1-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.