Skip to main content

Advertisement

SpringerLink
Log in

Precision medicine and the FDA's draft guidance on laboratory-developed tests

  • Correspondence
  • Published:

From Nature Biotechnology

View current issue Submit your manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Figure 1: The FDA's proposed risk-based framework for regulatory approval of in vitro diagnostic devices (IVDs).

References

  1. US Food and Drug Administration. Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests (LDT). http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416685.pdf (FDA, 2014).

  2. Ratner, M. Nat. Biotechnol. 32, 855 (2014).

    Article  CAS  Google Scholar 

  3. Nelson, C. et al. MMWR Morb. Mortal. Wkly. Rep. 63, 333 (2014).

    PubMed  PubMed Central  Google Scholar 

  4. Holtzman, N.A. & Watson, M.S. Final Report of the Task Force on Genetic Testing. http://www.genome.gov/10001733 (US Task Force, 1997).

    Google Scholar 

  5. Buchen, L. Nature 471, 428–432 (2011).

    Article  CAS  Google Scholar 

  6. Saslow, D. et al. Am. J. Clin. Pathol. 137, 516–542 (2012).

    Article  Google Scholar 

  7. Imperiale, T.F. et al. N. Engl. J. Med. 370, 1287–1297 (2014).

    Article  CAS  Google Scholar 

  8. Kwak, E.L. et al. N. Engl. J. Med. 363, 1693–1703 (2010).

    Article  CAS  Google Scholar 

  9. Hwang, T.J., Avorn, J., Carpenter, D. & Kesselheim, A.S. Health Aff. 33, 309–315 (2014).

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Faculty of Arts and Sciences, Harvard University, Cambridge, Massachusetts, USA

    Thomas J Hwang

  2. The Blackstone Group, London, United Kingdom

    Thomas J Hwang

  3. Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA

    Lisa Soleymani Lehmann

  4. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Program on Regulation, Therapeutics and Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA

    Aaron S Kesselheim

Authors
  1. Thomas J Hwang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lisa Soleymani Lehmann
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Aaron S Kesselheim
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Aaron S Kesselheim.

Ethics declarations

Competing interests

T.J.H. is employed by Blackstone, but Blackstone and Blackstone's clients were not involved in the decision to pursue this research project and did not contribute in any way to it. The views expressed in this manuscript are those of the authors and do not represent the views of, and do not constitute a recommendation by, Blackstone or any of its affiliated or subsidiary entities. The authors' employers, grantors and funders had no role in the design and conduct of the study; preparation, review or approval of the manuscript; or the decision to submit the manuscript for publication.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hwang, T., Lehmann, L. & Kesselheim, A. Precision medicine and the FDA's draft guidance on laboratory-developed tests. Nat Biotechnol 33, 449–451 (2015). https://doi.org/10.1038/nbt.3221

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt.3221

  • Springer Nature America, Inc.

Search

Navigation