25
Views
9
CrossRef citations to date
0
Altmetric
Miscellaneous

Molecular diagnostics: an FDA perspective

, &
Pages 129-140 | Published online: 09 Jan 2014

References

  • Schena M, Shalon D, Davis RW etal. Quantitative monitoring of gene expression patterns with a complementary DNA microarray. Science 270(4) 67–70 (1995).
  • Shalon D, Smith SJ, Brown PO. A DNA microarray system for analyzing complex DNA samples using two-color fluorescent probe hybridization. Genome Res. 6, 639–45 (1996).
  • Brown PO, Botstein D. Exploring the new world of the genome with DNA microarrays. Nature Genet. 21, 33–37 (1999).
  • •Provides an overview of DNA microarray.
  • Sreekumar A, Nyati MK, Varambally S etal Profiling of cancer cells using protein microarrays: discovery of novel radiation-regulated proteins. Cancer Res. 61, 7585–7593 (2001).
  • MacBeath G. Proteomics comes to the surface. Nature Biotechnol 19, 8289 (2001).
  • •Discusses the issues related to proteomics technologies.
  • Walter G, Bussow K, Lueking A etal High-throughput protein arrays: prospects for molecular diagnostics. Trends Mal Med. 8, 250–253 (2002).
  • •Provides detailed review of protein array technologies and its applications in molecular diagnostics.
  • Kuruvilla FG, Shamji AF, Stemson SM etal Dissecting glucose signalling with diversity-oriented synthesis and small-molecule microarrays. Nature 416, 653–657 (2002).
  • Paweletz CP, Charboneau L, Bichsel VE et al Reverse phase protein microarrays which capture disease progression show activation of prosurvival pathways at the cancer invasion front. Oncogene 20, 1981–1989 (2001).
  • Torhorst J, Bucher C, Kononen J etal Tissue microarrays for rapid linking of molecular changes to clinical end-points. Am. Pathol 159, 2249–2256 (2001). ioFigeys D, Pinto D. Proteomics on a chip: promising developments. Dectrophoresis22, 208–216 (2001).
  • Gullans SR. Of microarrays and meandering data points. Nature Genet. 26, 4–5 (2000).
  • DeRisi J, Penland L, Brown PO etal Use of a cDNA microarray to analyse gene expression patterns in human cancer. Nature Genet. 14, 457–460 (1996).
  • Rosenwald A, Wright G, Chan WC etal Lymphoma/Leukemia Molecular Profiling Project. The use of molecular profiling to predict survival after chemotherapy for diffuse large-B-cell lymphoma. N Engl. Med. 346, 1937–1947 (2002).
  • varh Veer LJ, Dai H, van de Vijver MJ etal Gene expression profiling predicts clinical outcome of breast cancer. Nature 415, 530–536 (2002).
  • Luo J, Duggan DJ, Chen Y etal Human prostate cancer and benign prostatic hyperplasia: molecular dissection by gene expression profiling. Cancer Res. 61, 4683–4688 (2001).
  • Bubendorf L, Kolmer M, Kononen J etal Hormone therapy failure in human prostate cancer: analysis by complementary DNA and tissue microarrays. j Natl Cancer Inst. 91, 1758–1764 (1999).
  • Hedenfalk I, Duggan D, Chen Y. Gene expression profiles in hereditary breast cancer. N. Engl. Med 244, 539–548 (2001).
  • Roses AD. Genome-based pharmacogenetics and the pharmaceutical industry. Nature Rev Drug Discov. 1, 541–548 (2002).
  • ••Discusses the role of pharrnacogeneticsand the drug industry.
  • Kim S, Dougherty ER, Chen Y etal Multivariate Measurement of Gene Expression Relationships. Genomics 67, 201–209 (2000).
  • Javed K, Jun SW, Markus R etal Classification and diagnostic prediction of cancers using gene expression profiling and artificial neural networks. Nature Med. 7, 673–679 (2001).
  • Altman RB, Klein TE. Challenges for biomediacl informatics and pharmacogenomics. Ann. Rev PharmacolToxicol 42, 113–133 (2002).
  • Nuwaysir EF, Bittner M, Trent J etal Microarrays and toxicology: the advent of toxicogenomics. Mo/. Carcinogenesis 24,153–159 (1999).
  • Waring JF, Jolly RA, Ciurlionis R etal Clustering of hepatotoxins based on mechanism of toxicity using gene expression profiles. Nature Genet. 29, 365–371 (2001).
  • Bittner P, Meltzer Y, Chen Y etal Molecular classification of cutaneous malignant melanoma by gene expression profiling. Nature 406, 536–540 (2000).
  • Brown PO, Hartwell L. Genomics and human disease-variations on variation. Nature Genet. 18, 91–93 (1998).
  • •Discusses the role of genomics in the diagnosis of human diseases.
  • Hamadeh HK, Bushel PR, Jayadev S etal Gene expression analysis reveals chemical-specific profiles. Toxica Sc]. 67, 219–231 (2002).
  • He B, Munson AE, Meade BJ. Analysis of gene expression induced by irritant and sensitizing chemicals using oligonucleotide arrays. Int. Immunopharmacol 1, 867–879 (2001).
  • Petricoin EF, Ardekani AM, Hitt BA eta]. Use of proteomic patterns in serum to identify ovarian cancer. Lancet 359, 572–577 (2002).
  • •Novel use SELDI-TOF technologies in combination with bioinformatics for the diagnosis of ovarian cancer at an early stage.
  • Cantor CR. Pharmacogenetics becomes pharmacogenomics: wake up and get ready. Mal Diagn. 4, 287–288 (1999).
  • Hamadeh HK, Bushel P, Tucker CJ, Detection of diluted gene expression alterations using cDNA arrays. Rio7i,chniques 32, 322–329 (2002).
  • Thomas RS, Rank DR, Penn SG etal. Identification of toxicologically predictive gene sets using cDNA microarrays. Mol. Pharmacol 60, 1189–1194 (2001)
  • Brazma A, Hingamp P, Quackenbush J etal Minimum information about a microarray experiment (MIAME) — toward standards for microarray data. Nature Genet. 29, 365–71 (2001).
  • Butte A. The use and analysis of microarray data. Nature Rev. Drug Discov 1, 951–960 (2002).
  • ••Reviews the different ways to analyse largesets of microarray data.
  • Petricoin EF, Hackett, JL, Lesko LJ etal Medical applications of microarray technologies: a regulatory science perspective. Nature Genet. (Suppl.) 32, 474–479 (2002).

Websites

  • www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/cfrsearch.cfm (Viewed February 2003)
  • www.fda.gov/cdrh/devadvice/ide/ application.shtml#required_element (Viewed February 2003)
  • www.fda.gov/cdrh/comp/ivdreg.html and http://www.fda.gov/cdrh/ode/d99–1.html (Viewed February 2003)
  • www.fda.gov/cdrh/k863.html (Viewed February 2003)
  • www.fda.gov/cdrh/dsma/pmaman/ front.html (Viewed February 2003)
  • www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfggp/Results.CFM (Viewed February 2003)
  • www.accessdata.fda.goviscriptilcdrh/ cfdocs/cfcfr/CFRSearch.cfm?FR = 864.4020 (Viewed February 2003) 108 www.fda.gov/cdrh/devadvice/332.html (Viewed February 2003)
  • www.fda.gov/cder/calendar/meeting/ phrma52002/workbook.pdf (Viewed February 2003)
  • www.ilsi.org/file/genomics.pdf (Viewed February 2003)
  • http://www.hupo.org (Viewed February 2003)

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.