Detours on the road to personalized medicine: Barriers to biomarker validation and implementation

JAMA

Volumn 306, Issue 17, 2011, Pages 1914-1915

  Fiore, Louis D ^a,b   D'Avolio, Leonard William ^a,c  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b BOSTON UNIVERSITY   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; DNA; MESSENGER RNA;

BREAST CANCER; CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DIAGNOSTIC TEST; DNA SEQUENCE; DRUG DELIVERY SYSTEM; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; GENETIC ASSOCIATION; GENOME ANALYSIS; GENOTYPE; GOVERNMENT; HEALTH CARE COST; HEALTH CARE DELIVERY; HUMAN; MEDICAL INFORMATION SYSTEM; MEDICARE; MICROARRAY ANALYSIS; NOTE; PERSONALIZED MEDICINE; POINT OF CARE TESTING; PRIORITY JOURNAL; REIMBURSEMENT; RNA SEQUENCE; SINGLE NUCLEOTIDE POLYMORPHISM; VALIDATION PROCESS;

EID: 80355148400     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2011.1605     Document Type: Note

References (7)

1. Hunter DJ, Kraft P. Drinking from the fire hose - statistical issues in genomewide association studies. N Engl J Med. 2007;357(5):436-439. (Pubitemid 47204871)
2. Kohane IS, Masys DR, Altman RB. The incidentalome: a threat to genomic medicine. JAMA. 2006;296(2):212-215. (Pubitemid 44050375)
3. US Food and Drug Administration. Draft guidance for industry: clinical laboratories, and FDA staff: in vitro diagnostic multivariate index assays, July 26, 2007. http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm071455.pdf. Accessed October 14, 2011.
4. Dana Farber Cancer Institute. OncoMap: profiling-tumor-DNA. http://www.dana-farber.org/Research/Featured-Research/OncoMap--Profiling-tumor- DNA.aspx. Accessed October 5, 2011.
5. Partners HealthCare Center for Personalized Genetic Medicine. Gene insight suite. http://pcpgm.partners.org/it-solutions/geneinsight. Accessed October 5, 2011.
6. Genomic Health Inc. Oncotype DX breast cancer assay and the Oncotype DX colon cancer assay. http://oncotypedx.com. Accessed October 5, 2011.
7. Fiore LD, Brophy M, Ferguson RE, et al. A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen. Clin Trials. 2011;8(2):183-195.