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Expert Review of Molecular Diagnostics Volume 11, 2011 - Issue 4
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Perspective

Regulating molecular diagnostic assays: developing a new regulatory structure for a new technology

Jeffrey N Gibbs Hyman, Phelps & McNamara, PC, 700 Thirteenth Street, NW Suite 1200, Washington, DC 20005, USA. [email protected]
Pages 367-381 | Published online: 09 Jan 2014

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Craig Van Dyke. (2013) Research Policies for Schizophrenia in the Global Health Context. International Journal of Mental Health 42:1, pages 51-76.
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Linnea M Baudhuin, Leslie J Donato & Timothy S Uphoff. (2012) How novel molecular diagnostic technologies and biomarkers are revolutionizing genetic testing and patient care. Expert Review of Molecular Diagnostics 12:1, pages 25-37.
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John Peabody, Trever Burgon, David Paculdo, Othman Ouenes, Enrico de Belen, Mike Richey, Richard M Thayer & Mickey Urdea. (2021) Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company. BMJ Innovations 7:1, pages 11-17.
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Luc Bissonnette & Michel G. Bergeron. 2015. Current and Emerging Technologies for the Diagnosis of Microbial Infections. Current and Emerging Technologies for the Diagnosis of Microbial Infections 87 110 .
François Thomas & Ahmad Awada. 2015. Next Generation Sequencing in Cancer Research, Volume 2. Next Generation Sequencing in Cancer Research, Volume 2 19 37 .
François Thomas, Christine Desmedt, Philippe Aftimos & Ahmad Awada. (2014) Impact of tumor sequencing on the use of anticancer drugs. Current Opinion in Oncology 26:3, pages 347-356.
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Julius Alexander SteffenChristian Lenz. (2013) Technological evolution of diagnostic testing in oncology. Personalized Medicine 10:3, pages 275-283.
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Luc Bissonnette & Michel G. Bergeron. (2012) Multiparametric technologies for the diagnosis of syndromic infections. Clinical Microbiology Newsletter 34:20, pages 159-168.
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Luc Bissonnette & Michel G. Bergeron. (2012) Infectious Disease Management through Point-of-Care Personalized Medicine Molecular Diagnostic Technologies. Journal of Personalized Medicine 2:2, pages 50-70.
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