Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Developing context-specific next-generation sequencing policy

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Rent or buy this article

Prices vary by article type

from$1.95

to$39.95

Prices may be subject to local taxes which are calculated during checkout

Figure 1: Breakdown of clinical offerings.

References

  1. Korf, B.R. & Rehm, H.L. J. Am. Med. Assoc. 309, 1511–1521 (2013).

    Article  CAS  Google Scholar 

  2. Collins, F.S. & Hamburg, M.A. N. Engl. J. Med. 369, 2369–2371 (2013).

    Article  CAS  Google Scholar 

  3. US Food and Drug Administration. Draft guidance for industry, Food and Drug Administration staff, and clinical laboratories: framework for regulatory oversight of laboratory developed tests (LDTs) http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm416685.pdf (FDA, 3 October 2014).

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

    Article  CAS  Google Scholar 

  5. Evans, B.J., Burke, W. & Jarvik, G.P. N. Engl. J. Med. 372, 2258–2264 (2015).

    Article  CAS  Google Scholar 

  6. US Food and Drug Administration. The public health evidence for FDA oversight of laboratory developed tests: 20 case studies http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf (FDA, 16 November 2015).

  7. Deverka, P.A., Kaufman, D. & McGuire, A.L. J. Am. Med. Assoc. 312, 1857–1858 (2014).

    Article  CAS  Google Scholar 

  8. Curnutte, M.A., Frumovitz, K.L., Bollinger, J.M., McGuire, A.L. & Kaufman, D.J. Nat. Biotechnol. 32, 980–982 (2014).

    Article  CAS  Google Scholar 

  9. Phillips, K.A. et al. Health Aff. 33, 1246–1253 (2014).

    Article  Google Scholar 

  10. Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976).

  11. The American College of Obstetricians and Gynecologists. Frequently asked questions, FAQ179, pregnancy. Preconception carrier screening http://www.acog.org/-/media/For-Patients/faq179.pdf?dmc=1&ts=20150327T1659412690 (2012).

  12. Edwards, J.G. et al. Obstet. Gynecol. 125, 653–662 (2015).

    Article  Google Scholar 

  13. Dondorp, W. et al. Eur. J. Hum. Genet. 11, 1592 (2015).

    Article  Google Scholar 

  14. Gregg, A.R. et al. Genet. Med. 15, 395–398 (2013).

    Article  CAS  Google Scholar 

  15. Wang, J.-C. et al. Genet. Med. 17, 234–236 (2015).

    Article  CAS  Google Scholar 

  16. US National Institutes of Health. NIH News http://www.genome.gov/27554919 (4 September 2013).

  17. American Academy of Pediatrics. Pediatrics 131, 620–622 (2013).

  18. Yang, Y. et al. J. Am. Med. Assoc. 312, 1870–1879 (2014).

    Article  CAS  Google Scholar 

  19. ACMG Board of Directors. Genet. Med. 17, 505–507 (2015).

  20. Mertz, A. Statement of Alan Mertz, president, the American Clinical Laboratory Association, for US House of Representatives Energy and Commerce Committee Subcommittee on Health, hearing on 21st Century Cures: Examining the Regulation of Laboratory Developed Tests http://docs.house.gov/meetings/IF/IF14/20140909/102625/HHRG-113-IF14-Wstate-MertzA-20140909.pdf (9 September 2014).

  21. Green Park Collaborative. Initial medical policy and model coverage guidelines for clinical next generation sequencing in oncology: report recommendations http://www.cmtpnet.org/docs/resources/Full_Release_Version_August_13__2015.pdf (17 August 2015).

  22. Topol, E.J. & Damani, S.B. J. Am. Coll. Cardiol. 56, 1564–1566 (2010).

    Article  Google Scholar 

  23. Lee, H. et al. Lab. Med. Online 4, 198–202 (2014).

    Article  Google Scholar 

  24. Dunnenberger, H.M. et al. Annu. Rev. Pharmacol. Toxicol. 55, 89–106 (2015).

    Article  CAS  Google Scholar 

  25. College of American Pathologists. Proposed approach to oversight of laboratory developed tests http://www.cap.org/apps/docs/advocacy/ldt/oversight_model.pdf (28 April 2010).

  26. Monaghan, K.G. et al. Genet. Med. 15, 314–315 (2013).

    Article  Google Scholar 

  27. Robson, M.E. et al. J. Clin. Oncol. 33, 3660–3667 (2015).

    Article  CAS  Google Scholar 

  28. US Food and Drug Administration. Developing analytical standards for NGS testing http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM468521.pdf (2015).

Download references

Acknowledgements

We thank G. Javitt for thoughtful commentary on the manuscript. This work was funded by National Human Genome Research Institute grant R01-HG006460 to A.L.M.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Mary A Majumder.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Additional information

Editor's note: This article has been peer-reviewed.

Supplementary information

Supplementary Table 1

Surveyed companies and academic institutions (PDF 108 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Curnutte, M., Frumovitz, K., Bollinger, J. et al. Developing context-specific next-generation sequencing policy. Nat Biotechnol 34, 466–470 (2016). https://doi.org/10.1038/nbt.3545

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt.3545

This article is cited by

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing