Textbook of Personalized Medicine - Second Edition [2015]

670 Table 22.1 Drugs with genetic information in their labels Drug Company Indication Genotype Effect Label Abacavir (Ziagen) Gl ...

671 distinguish allelic variants of these enzymes are considered to be well established and, therefore, valid biomarkers. A prob ...

672 development process for medical products – the Critical Path – to make product development more predictable and less costly. ...

673 combination of genes or proteins is a better indicator of disease or disease risk than a single gene or protein. FDA conside ...

674 by a particular use. In this instance, a test for the prognosis of breast cancer would require different data than a test us ...

675 device outweigh risks; and (b) an already approved product exists, but labeling for that product must be revised to address ...

676 Further, it will be helpful if the device sponsor and the therapeutic product sponsor submit information about the proposed ...

677 technology suppliers Affymetrix and Illumina, which make the tools the testing companies use. In 2008, Department of Health ...

678 Ensuring that the public has information adequate to making informed choices about genetic testing is a prerequisite to real ...

679 data from a test that has not been validated by the FDA”. In 2010, the FDA sent let- ters to fi ve companies – 23andMe, Navi ...

680 Genetic counseling appropriate to the type of test and disease should be offered; and for some tests psychosocial evaluatio ...

K.K. Jain, Textbook of Personalized Medicine, DOI 10.1007/978-1-4939-2553-7_23, 681 © Springer Science+Business Media New York 2 ...

682 Personalized Medicine and Orphan Drug Syndrome There is no satisfactory defi nition of an orphan disease. In the USA it is d ...

683 Lowering the Cost of Sequencing the Human Genome Previously it was very expensive to sequence the three billion base pairs o ...

684 tests had received $600 million in grants and tax credits under Qualifying Therapeutic Discovery Project (QTDP) in the US. T ...

685 particular drug. The results of such a trial would be far more conclusive and focused than those of trials that do not use p ...

686 Personalized Medicine and the Rising Healthcare Costs in the US Overall, health care infl ation continues to rise precipitou ...

687 Reduction of high expense of hospital stay Predictive medicine will reduce costs by prevention The healthcare reform bill ...

688 Oncotype Dx (Genomic Health) is a test with compelling cost-saving potential. It is used to predict chemotherapy benefi t fo ...

689 characterized as “poor metabolizers” (1–10 % of Caucasians). Studies have shown that pharmacogenetic analyses will signifi c ...