In Vitro Diagnostics and Theranostics: World Market Analysis 2010-202527 Sep 2011 • by Natalie Aster
Genetic Testing is the newest category to be added to the EDMA classifications. It consists of any IVD tests which seek to analyse a person's genes to provide diagnostic or other information. Foetuses may be screened for certain diseases in the womb. Newborns are routinely tested for various genetic diseases, especially phenylketonuria. A test may be used to confirm diagnosis of a hereditary condition such as haemochromatosis. People may wish to know whether they are a carrier for certain genetic diseases, for example sickle-cell anaemia. Elsewhere, certain mutations are known to raise the risk of breast cancer. By testing for these mutations, patients can make prophylactic lifestyle or treatment decisions. Pharmacogenomic tests help predict whether a patient will benefit from a drug, e.g. the K-RAS test for Vectibix.
The report “In Vitro Diagnostics and Theranostics: World Market Analysis 2010-2025” by Visiongain examines the commercial prospects for in vitro diagnostics (IVD) in the global healthcare market. It also covers theranostics, a fusion of drug therapy and diagnostics to optimise efficacy and safety, as well as streamline drug development.
Published: June 2010
Price: US$ 2,461.00
Report Sample Abstract
Genetic Testing is still in its infancy and as such it currently represents a small proportion of the global IVD market. However its uptake is widespread and its growth rate outstrips that of any other IVD submarket.
There are several factors driving growth of the genetic testing market. Pharmacogenomics and personalisation of medical treatment are perhaps the most important. Genetic tests are an important tool for guiding prescribing decisions in some areas, and their use will continue to expand over the next fifteen years.
Use of theranostic tests improves efficacy, tolerability and economy of healthcare, making them attractive to physicians, patients and payers.
PARP inhibitors are predicted to be future blockbuster drugs for treating breast cancer. They are effective against tumours with mutated BRCA genes. This mutation can be inherited or acquired.
Those with the inherited version are at significantly higher risk of developing breast and ovarian cancer. In Q2 2010, Myriad Genetics reportedly lost a court case to determine the validity of the patent they had filed on the BRCA gene. They apparently had been using the patent to prevent any other company manufacturing or marketing a test for BRCA mutations, or even institutions using the gene in research. Judge Sweet of the United States District Court for the Southern District of New York ruled that the gene was a natural product and not patentable. Myriad may appeal to the Federal courts.
Knowing what type of cancer a patient has is vital for selecting the correct treatment. Often it is straightforward: a tumour is discovered in the breast and so breast cancer treatment protocol can be applied. However, many cancers are of unknown origin; that is, they have already metastasised and the site of the original tumour is not clear. IVD tests are now available to analyse the genetic make up of the cancer to determine where it originated.
BioTheranostics' CancerTYPE ID is a molecular classification assay that measures and integrates the expression of 92 genes to distinguish up to 54 different tumour types.
More information can be found in the report “In Vitro Diagnostics and Theranostics: World Market Analysis 2010-2025” by Visiongain.
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