Skip to main content
SpringerLink
Log in

Small Business Development for Molecular Diagnostics

  • Protocol
  • First Online:
Molecular Profiling

Part of the book series: Methods in Molecular Biology ((MIMB,volume 823))

Abstract

Molecular profiling, which is the application of molecular diagnostics technology to tissue and blood ­specimens, is an integral element in the new era of molecular medicine and individualized therapy. Molecular diagnostics is a fertile ground for small business development because it can generate products that meet immediate demands in the health-care sector: (a) Detection of disease risk, or early-stage disease, with a higher specificity and sensitivity compared to previous testing methods, and (b) “Companion diagnostics” for stratifying patients to receive a treatment choice optimized to their individual disease. This chapter reviews the promise and challenges of business development in this field. Guidelines are provided for the creation of a business model and the generation of a marketing plan around a candidate molecular diagnostic product. Steps to commercialization are outlined using existing molecular diagnostics companies as learning examples.

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

Access this chapter

Log in via an institution
Protocol
USD 49.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Mamounas, E. P., Tang, G., Fisher, B., Paik, S., Shak, S., Costantino, J. P. et al. (2010) Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol 28, 1677–83.

    Article  PubMed  Google Scholar 

  2. Paik, S., Tang, G., Shak, S., Kim, C., Baker, J., Kim, W. et al. (2006) Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 24, 3726–34.

    Article  PubMed  CAS  Google Scholar 

  3. Paik, S., Shak, S., Tang, G., Kim, C., Baker, J., Cronin, M. et al. (2004) A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 351, 2817–26.

    Article  PubMed  CAS  Google Scholar 

  4. American Hospital Association (2010) Fast Facts on US Hospitals. American Hospital Association: Chicago, IL, http://www.aha.org/aha/content/2010/pdf/101207fastfacts.pdf Accessed 16 February 2011

  5. Batchelder, K., Miller, P. (2006) A change in the market--investing in diagnostics. Nat Biotechnol 24, 922–6.

    Article  PubMed  CAS  Google Scholar 

  6. Goldstein, D. B. (2010) Personalized medicine. Nature 463, 10.

    Article  Google Scholar 

  7. Callaway, E. (2011) Cancer-gene testing ramps up. Nature 467, 766–7.

    Article  Google Scholar 

  8. Collins, F. (2010) Has the revolution arrived? Nature 464, 674–5.

    Article  PubMed  CAS  Google Scholar 

  9. Hamburg, M. A., Collins, F. S. (2010) The path to personalized medicine. N Engl J Med 363, 301–4.

    Article  PubMed  CAS  Google Scholar 

  10. Taube, S. E., Jacobson, J. W., Lively, T. G. (2005) Cancer diagnostics: decision criteria for marker utilization in the clinic. Am J Pharmacogenomics 5, 357–64.

    Article  PubMed  Google Scholar 

  11. Schafer, J. C. (2007) Molecular Diagnostic Assays: Leading a High Value Evolutions. 2011, in Biotechnology Focus

    Google Scholar 

  12. Khoury, M. J., Evans, J. P., Burke, W. (2010) A reality check for personalized medicine. Nature 464, 680.

    Article  Google Scholar 

  13. Doig, A. (2007) Molecular Diagnostics Market Assessment. Genetic Engineering & Biotechnology News 27, http://www.genengnews.com/gen-articles/molecular-diagnostics-market-assessment/2006/. Accessed 16 February 2011.

  14. Sannes, L. (2007) Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape. in Insight Pharma Reports. Cambridge Healthtech Institute, 232.

    Google Scholar 

  15. Southern, E. M. (1974) An improved method for transferring nucleotides from electrophoresis strips to thin layers of ion-exchange cellulose. Anal Biochem 62, 317–8.

    Article  PubMed  CAS  Google Scholar 

  16. Leslie, D. E., Azzato, F., Ryan, N., Fyfe, J. (2003) An assessment of the Roche Amplicor Chlamydia trachomatis/Neisseria gonorrhoeae multiplex PCR assay in routine diagnostic use on a variety of specimen types. Commun Dis Intell 27, 373–9.

    PubMed  Google Scholar 

  17. Whiley, D. M., Tapsall, J. W., Sloots, T. P. (2006) Nucleic acid amplification testing for Neisseria gonorrhoeae: an ongoing challenge. J Mol Diagn 8, 3–15.

    Article  PubMed  CAS  Google Scholar 

  18. Shah, S. S., Ketterling, R. P., Goetz, M. P., Ingle, J. N., Reynolds, C. A., Perez, E. A. et al. (2010) Impact of American Society of Clinical Oncology/College of American Pathologists guideline recommendations on HER2 interpretation in breast cancer. Hum Pathol 41, 103–6.

    Article  PubMed  CAS  Google Scholar 

  19. Jacobs, T. W., Gown, A. M., Yaziji, H., Barnes, M. J., Schnitt, S. J. (1999) Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system. J Clin Oncol 17, 1983–7.

    PubMed  CAS  Google Scholar 

  20. Hammond, M. E., Hayes, D. F., Dowsett, M., Allred, D. C., Hagerty, K. L., Badve, S. et al. (2010) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med 134, e48-72.

    PubMed  CAS  Google Scholar 

  21. Veer, L. J., Dai, H., van de Vijver, M. J., He, Y. D., Hart, A. A., Mao, M. et al. (2002) Gene expression profiling predicts clinical outcome of breast cancer. Nature 415, 530–6.

    Article  PubMed  Google Scholar 

  22. van de Vijver, M. J., He, Y. D., Veer, L. J., Dai, H., Hart, A. A., Voskuil, D. W. et al. (2002) A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 347, 1999–2009.

    Article  PubMed  Google Scholar 

  23. Winter, P. (2009) Let’s make a deal. The Journal of Life Sciences 14–15.

    Google Scholar 

  24. Levine, D. S. (2009) A diagnosis of deals. The Journal of Life Sciences 12–13.

    Google Scholar 

  25. Meckley, L. M., Neumann, P. J. (2010) Personalized medicine: factors influencing reimbursement. Health Policy 94, 91–100.

    Article  PubMed  Google Scholar 

  26. Allegra, C. J., Aberle, D. R., Ganschow, P., Hahn, S. M., Lee, C. N., Millon-Underwood, S. et al. (2010) National Institutes of Health State-of-the-Science Conference statement: Diagnosis and Management of Ductal Carcinoma In Situ September 22–24, 2009. J Natl Cancer Inst 102, 161–9.

    Article  PubMed  Google Scholar 

  27. Kontos, E. Z., Viswanath, K. (2011) Cancer-related direct-to-consumer advertising: a critical review. Nat Rev Cancer 11, 142–50.

    Article  PubMed  CAS  Google Scholar 

  28. Farkas, D. H., Holland, C. A. (2009) Direct-to-consumer genetic testing: two sides of the coin. J Mol Diagn 11, 263–5.

    Article  PubMed  Google Scholar 

  29. Levine, D. S. (2007) Getting Personal. The Journal of Life Sciences 42–28.

    Google Scholar 

  30. Elkin, E. B., Weinstein, M. C., Winer, E. P., Kuntz, K. M., Schnitt, S. J., Weeks, J. C. (2004) HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. J Clin Oncol 22, 854–63.

    Article  PubMed  Google Scholar 

  31. Ferrusi, I. L., Marshall, D. A., Kulin, N. A., Leighl, N. B., Phillips, K. A. (2009) Looking back at 10 years of trastuzumab therapy: what is the role of HER2 testing? A systematic review of health economic analyses. Per Med 6, 193–215.

    Article  PubMed  CAS  Google Scholar 

  32. Hunt, P. W., Harrigan, P. R., Huang, W., Bates, M., Williamson, D. W., McCune, J. M. et al. (2006) Prevalence of CXCR4 tropism among antiretroviral-treated HIV-1-infected patients with detectable viremia. J Infect Dis 194, 926–30.

    Article  PubMed  CAS  Google Scholar 

  33. Daar, E. S., Lynn, H. S., Donfield, S. M., Lail, A., O’Brien, S. J., Huang, W. et al. (2005) Stromal cell-derived factor-1 genotype, coreceptor tropism, and HIV type 1 disease progression. J Infect Dis 192, 1597–605.

    Article  PubMed  Google Scholar 

  34. Vandekerckhove, L., Verhofstede, C., Demecheleer, E., De Wit, S., Florence, E., Fransen, K. et al. (2011) Comparison of phenotypic and genotypic tropism determination in triple-class-experienced HIV patients eligible for maraviroc treatment. J Antimicrob Chemother 66, 265–272.

    Article  PubMed  CAS  Google Scholar 

  35. Rader, R. A. (2010) FDA Biopharmaceutical Product Approvals and Trends: Significantly More Approvals Were Granted in 2009. Biotechnology Information Institute. http://www.biopharma.com/approvals_2009.html. Accessed 16 Feb 2011

  36. Zenios, S., Chess, R. B., Denend, L. (2006) Genomic Health: Launching a Paradigm Shift…and an Innovative New Test (Case No: OIT49). Stanford Graduate School of Business: Palo Alto, CA, 1–36.

    Google Scholar 

  37. Ross, J. S., Hatzis, C., Symmans, W. F., Pusztai, L., Hortobagyi, G. N. (2008) Commercialized multigene predictors of clinical outcome for breast cancer. Oncologist 13, 477–93.

    Article  PubMed  Google Scholar 

  38. Farkas, D. H. (2008) Interview with Daniel H. Farkas, PhD, Executive Director of the Center for Molecular Medicine. Anagnostou, A., Rockville, telephone interview.

    Google Scholar 

  39. Farkas, D. H. (2008) Diagnostic Molecular Pathology in an Era of Genomics and Trans-lational Bioinformatics. Diagnostic Molecular Pathology 17, 1–2 10.1097/PDM.0b013e-31815dd481.

    PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Tatari Design Center and Zorba Marketing Incorporated, Alexandria, VA, USA

    Anthanasia Anagostou

  2. Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, VA, USA

    Lance A. Liotta

Authors
  1. Anthanasia Anagostou
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lance A. Liotta
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Lance A. Liotta .

Editor information

Editors and Affiliations

  1. Center for Applied Proteomics and, George Mason University, University Blvd. 10900, Manassas, 20110, Virginia, USA

    Virginia Espina

  2. Center for Applied Proteomics &, George Mason University, University Blvd. 10900, Manassas, 20110, Virginia, USA

    Lance A. Liotta

Rights and permissions

Reprints and permissions

Copyright information

© 2012 Springer Science+Business Media, LLC

About this protocol

Cite this protocol

Anagostou, A., Liotta, L.A. (2012). Small Business Development for Molecular Diagnostics. In: Espina, V., Liotta, L. (eds) Molecular Profiling. Methods in Molecular Biology, vol 823. Humana Press. https://doi.org/10.1007/978-1-60327-216-2_28

Download citation

  • DOI: https://doi.org/10.1007/978-1-60327-216-2_28

  • Published:

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-60327-215-5

  • Online ISBN: 978-1-60327-216-2

  • eBook Packages: Springer Protocols

Publish with us

Policies and ethics

Search

Navigation