FDA Approved Direct-To-Consumer (DTC) Genetic Testing For 10 Diseases, Including Alzheimer’s And Parkinson’s.

Prolonged struggle between manufacturers and regulatory bodies’ restraints growth of the growth

Manufacturers and regulatory bodies are the essential parts of healthcare ecosystem and cooperation between them is must for any development. Manufacturers drive innovation whereas regulatory authorities insures safety and efficacy of the product or process. However, the direct-to-consumer genetic testing devices market has seen very little cooperation. For instance, 23andMe was started in 2006 and the company started selling its direct-to-consumer (DTC) genetic testing devices in 2007 and was even named ‘Invention of the Year’ by Time magazine in 2008. However, in 2013, FDA ordered 23andMe to discontinue marketing its personal genome service (PGS), as the company had not obtained the legal regulatory approval. The company completely denied the charge and sold their products till 2015. In 2017, the company got first FDA approval for genetic tests for 10 diseases. The hindrance between the manufacturers and regulatory bodies restraints the market growth.

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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Easy accessibility along with increased incidences of chronic disease such as cancer, Alzheimer’s, and Parkinson’s is expected to drive growth of the market

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.

Increasing awareness about health, especially in developed economies such as U.S., Canada, and U.K. among others, and increasing incidences of chronic diseases such as cancer, Alzheimer’s, and Parkinson’s is majorly contributing to growth of the market. The reasons for this reactiveness varies with geography. For instance, in developed economies such as U.S. and Germany, aging population are more prone to chronic conditions, which include cancer, neurological disorders, and cardiovascular disorders. In 2017, FDA approved direct-to-consumer (DTC) genetic testing for 10 diseases, including Alzheimer’s and Parkinson’s. This has further certified direct-to-consumer (DTC) genetic testing devices for these conditions, which in turn, is expected to increase the use of direct-to-consumer (DTC) genetic tests among patients suffering from the medical conditions.

Limited accessibility to healthcare facilities, mainly in emerging economies such as Brazil, India, and China, is the major reason for low adoption of advanced technologies such as genetic tests. However, introduction of direct-to-consumer (DTC) genetic testing devices is expected to solve this problem as customers can use direct-to-consumer (DTC) genetic testing devices at their home.

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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