To Gain More Insights into the Direct-to-Consumer Genetic Testing Devices Market, Browse Summary of the Research Report –
Genetic testing is a type of medical test that determines changes in genes, chromosomes, or proteins. The tests was available only through healthcare professionals such as doctors, nurses, and genetic counselors. However, this trend is gradually shifting towards the customer or consumer. Genetic testing is now offered directly at home, and is called Direct-to-Consumer (DTC) Genetic Testing, which bypasses the mediators or facilitators such as Physicians, Genetic Counselors, and others. The most critical thing about the genetic tests is that these tests are for disease susceptibilities only and cannot be used alone for treatment decisions or other medical interventions. In genetic testing, interpretation is important and is transferred to individual patient, who may not be trained geneticist.
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Direct-to-Consumer (DTC) Genetic Testing is advantageous for manufacturers as it gives direct access to them to appeal to the customer and maximize their revenue. However, this testing provides easy access to the customer while chances of misinterpretation are really high.
The U.S. FDA has kept these tests in “Tier 3” category due to high chances of misinterpretation of direct-to-consumer (DTC) genetic testing. According to FDA, Tier 3 category means that there is no clinical validity or utility of such applications in healthy individuals in the population.
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Genetic testing requires patients or healthy individuals to visit trained medical professionals such as doctors, nurses or counselors, in order to get their test interpretations of the result. This process has now become unnecessary or voluntarily with the introduction of direct-to-consumer (DTC) genetic testing devices. This has significantly cut down the cost associated with testing and increasing accessibility of such tests to potential patients.
Table of Contents
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Top players in the market
Key players operating in the global direct-to-consumer genetic testing devices market include 23andMe, Pathway Genomics, Color Genomics, Counsyl, Inc., deCode genetics, Inc., Map My Gene, and GenePartner.
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