References
- Ashley EA, Butte AJ, Wheeler MT et al. Clinical assessment incorporating a personal genome. Lancet375, 1525–1535 (2010).
- Schena M, Shalon D, Davis RW, Brown PO. Quantitative monitoring of gene expression patterns with a complementary DNA microarray. Science270, 467–470 (1995).
- Jain KK. Applications of AmpliChip CYP450. Mol. Diagn.9, 119–127 (2005).
- Glas AM, Floore A, Delahaye LJ et al. Converting a breast cancer microarray signature into a high-throughput diagnostic test. BMC Genomics7, 278 (2006).
- Li X, Quigg RJ, Zhou J, Gu W, Nagesh Rao P, Reed EF. Clinical utility of microarrays: current status, existing challenges and future outlook. Curr. Genomics9(7), 466–474 (2008).
- Tezak Z, Ranamukhaarachchi D, Russek-Cohen E, Gutman S. FDA perspectives on potential microarray-based clinical diagnostics. Hum. Genomics2, 236–243 (2006).
- Leinonen M, Nieminen P, Kotaniemi-Talonen L et al. Age-specific evaluation of primary human papillomavirus screening vs conventional cytology in a randomized setting. J. Natl Cancer Inst.101(23), 1612–1623 (2009).
- Watson MS, Cutting GR, Desnick RJ et al. Cystic fibrosis population carrier screening: 2004 revision of American College of Medical Genetics mutation panel. Genet. Med.6, 387–391 (2004).
- Daly AK. Pharmacogenetics of the major polymorphic metabolizing enzymes. Fundam. Clin. Pharmacol.17, 27–41 (2003).
- Katsanis SH, Javitt G, Hudso K. A case study of personalized medicine. Science320, 53–54 (2008).
- Veltman JA. Genomic microarrays in clinical diagnosis. Curr. Opin. Pediatr.18, 598–603 (2006).
- Bejjani BA, Shaffer LG. Application of array-based comparative genomic hybridization to clinical diagnostics. J. Mol. Diagn.8, 528–553 (2006).
- Reich DE, Lander ES. On the allelic spectrum of human disease. Trends Genet.17, 502–510 (2001).
- Manolio TA, Collins FS, Cox NJ et al. Finding the missing heritability of complex diseases. Nature461, 747–753 (2009).
- Campbell G. Some issues in the statistical evaluation of genetic and genomic tests. J. Biopharm. Stat.14, 539–552 (2004).
- Quackenbush J. Microarray analysis and tumor classification. N. Engl. J. Med.354(23), 2463–2472 (2006).
- Ein-Dor L, Zuk O, Domany E. Thousands of samples are needed to generate a robust gene list for predicting outcome in cancer. Proc. Natl Acad. Sci. USA103(15), 5923–5928 (2006).
- van de Vijver MJ, He YD, van’t Veer LJ et al. A gene-expression signature as a predictor of survival in breast cancer. N. Engl. J. Med.347(25), 1999–2009 (2002).
- Buyse M, Loi S, van’t Veer L et al. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. J. Natl Cancer Inst.98, 1183–1192 (2006).
- Paik S, Shak S, Tang G et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N. Engl. J. Med.351(27), 2817–2826 (2004).
- Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Recommendations from the EGAPP Working Group: can tumor gene expression profiling improve outcomes in patients with breast cancer? Genet. Med.11(1), 66–73 (2009).
- Koscielny S. Why most gene expression signatures of tumors have not been useful in the clinic. Sci. Transl. Med.2(14), 14ps2 (2010).
- Cardoso F, Piccart-Gebhart M, van’t Veer L, Rutgers E; TRANSBIG Consortium. The MINDACT trial: the first prospective clinical validation of a genomic tool. Mol. Oncol.1(3), 246–251 (2007).
- Mook S, van’t Veer LJ, Rutgers EJ, Piccart-Gebhart MJ, Cardoso F. Individualization of therapy using Mammaprint: from development to the MINDACT Trial. Cancer Genomics Proteomics4(3), 147–155 (2007).
- Zujewski JA, Kamin L. Trial assessing individualized options for treatment for breast cancer: the TAILORx trial. Future Oncol.4(5), 603–610 (2008).
- Ross JS, Hatzis C, Symmans WF, Pusztai L, Hortobágyi GN. Commercialized multigene predictors of clinical outcome for breast cancer. Oncologist13, 477–493 (2008).
- Dumur CI, Lyons-Weiler M, Sciulli C, et al. Interlaboratory performance of a microarray-based gene expression test to determine tissue of origin in poorly differentiated and undifferentiated cancers. J. Mol. Diagn.10, 67–77 (2008).
- Sotiriou C, Wirapati P, Loi S et al. Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis. J. Natl Cancer Inst.98(4), 262–272 (2006).
- Valk PJ, Verhaak RG, Beijen MA et al. Prognostically useful gene-expression profiles in acute myeloid leukemia. N. Engl. J. Med.350(16), 1617–1628 (2004).
- Spira A, Beane JE, Shah V et al. Airway epithelial gene expression in the diagnostic evaluation of smokers with suspect lung cancer. Nat. Med.13(3), 361–366 (2007).
- Negrini M, Nicoloso MS, Calin GA. MicroRNAs and cancer – new paradigms in molecular oncology. Curr. Opin. Cell Biol.21(3), 470–479 (2009).
- Metzker ML. Sequencing technologies – the next generation. Nat. Rev. Genet.11(1), 31–46 (2010).
- Morozova O, Hirst M, Marra MA. Applications of new sequencing technologies for transcriptome analysis. Annu. Rev. Genomics Hum. Genet.10, 135–151 (2009).
Websites
- Medical News Today. Global molecular diagnostics market to reach 3.67 billion dollars by 2010, according to new report by Global Industry Analysts, Inc. www.medicalnewstoday.com/articles/104274.php
- Knol. Global cancer market review 2008 (world top ten cancer drugs) http://knol.google.com/k/global-cancer-market-review-2008-world-top-ten-cancer-drugs#
- Draft guidance for industry, clinical laboratories, and FDA staff. In vitro diagnostic multivariate index assays www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071455.pdf
- National Cancer Institute. Pap test www.cancer.gov/cancertopics/factsheet/Detection/Pap-test
- DR.Chip Biotech, Inc. Product characteristics www.bio-drchip.com.tw/HOME2ENG/DR.%20HPV%20IVD%20Kit.asp
- Osmetech. eSensor® XT-8 System Cystic Fibrosis Genotyping Test www.osmetech.com/cfgenotyping.htm
- Counsyl www.counsyl.com
- Counsyl. Publications and technical details www.counsyl.com/medical/publications/
- Universal Screening for Recessive Childhood Diseases http://sequencing.ncgr.org/index.php?option=com_content&view=article&id=44:preventing-rare-genetic-diseases&catid=37:medical-endeavors&Itemid=95
- Ambry Genetics®. News www.ambrygen.com/AmbryScreen-News.html
- Osmetech www.osmetech.com
- Roche www.roche.com/products
- Agendia www.agendia.com