Diagnostic Kits/Patents and the Progress of Personalized Medicine: Difference between revisions
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Herder, M., Patents & the Progress of Personalized Medicine: Biomarkers Research as Lens. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1435468 [Accessed October 1, 2009]. | Herder, M., Patents & the Progress of Personalized Medicine: Biomarkers Research as Lens. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1435468 [Accessed October 1, 2009]. | ||
Types of biomarkers: | |||
#Diagnostic biomarkers: "identify the presence of disease at the earliest stage, before clinical manifestation. (Wilson et al., 2007) | #Diagnostic biomarkers: "identify the presence of disease at the earliest stage, before clinical manifestation. (Wilson et al., 2007) | ||
#Prognostic biomarkers "stratify risk of disease progression in patients undergoing definitive therapy." (Wilson et al., 2007) | #Prognostic biomarkers "stratify risk of disease progression in patients undergoing definitive therapy." (Wilson et al., 2007) | ||
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Types of "genetic testing" services | Types of "genetic testing" services | ||
#Diagnostics: "companies can go to market as soon as they have phenotype-gene association information and the necessary | #Diagnostics: "companies can go to market as soon as they have phenotype-gene association information and the necessary genetic sequencing equipment in hand. (Herder, M., 2009) | ||
genetic sequencing equipment in hand. (Herder, M., 2009) | |||
#Pharmacogenomics(also pharmacogenetics): personalized medicine through incorporate genetic information into drug choice | #Pharmacogenomics(also pharmacogenetics): personalized medicine through incorporate genetic information into drug choice | ||
#Theragnostics: focuses on "integration of information from a diverse set of biomarkers" (Herder, M., 2009) | #Theragnostics: focuses on "integration of information from a diverse set of biomarkers" (Herder, M., 2009) | ||
Regulatory framework | |||
*Regulation is carried out by the FDA and/or the Centers for Medicare and Medicaid Services (CMS) | |||
**Testing requires both analytically and clinically valid | |||
**Currently there is ambiguity in the process | |||
Revision as of 11:30, 2 October 2009
Herder, M., Patents & the Progress of Personalized Medicine: Biomarkers Research as Lens. SSRN eLibrary. Available at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1435468 [Accessed October 1, 2009].
Types of biomarkers:
- Diagnostic biomarkers: "identify the presence of disease at the earliest stage, before clinical manifestation. (Wilson et al., 2007)
- Prognostic biomarkers "stratify risk of disease progression in patients undergoing definitive therapy." (Wilson et al., 2007)
- Predictive biomarkers: identify patients most likely to respond to specific interventions." (Wilson et al., 2007)
- Therapeutic biomarkers: "provide a quantifiable measure of response to therapy in patients undergoing treatment." (Wilson et al., 2007)
- Toxicity biomarkers: "biomarkers can be used to identify patients at risk for developing adverse reactions to individual therapeutics." (Wilson et al., 2007)
Types of "genetic testing" services
- Diagnostics: "companies can go to market as soon as they have phenotype-gene association information and the necessary genetic sequencing equipment in hand. (Herder, M., 2009)
- Pharmacogenomics(also pharmacogenetics): personalized medicine through incorporate genetic information into drug choice
- Theragnostics: focuses on "integration of information from a diverse set of biomarkers" (Herder, M., 2009)
Regulatory framework
- Regulation is carried out by the FDA and/or the Centers for Medicare and Medicaid Services (CMS)
- Testing requires both analytically and clinically valid
- Currently there is ambiguity in the process