The Food and Drug Administration has granted permission to DNA testing company 23andMe to sell Personal Genome Service Genetic Health Risk or GHR tests for 10 diseases.
For consumers, it is a breakthrough as it eliminates the middlemen, namely health professionals whom they consult for genetic tests.
The tests will help individuals know their genetic vulnerability to various diseases including Parkinson's and Alzheimer's.
The FDA said in a statement that these are the first-ever direct-to-consumer tests authorized for delivering information regarding an individual's predisposition to certain diseases or conditions.
Advance information helps in modifying one's lifestyle through consultations with health care professionals.
"Consumers can now have direct access to certain genetic risk information," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
But Shuren asked people to understand that mere genetic risk does not suggest a person will be developing a particular disease.
Genetic Risk Does Not Spell Disease
Even though GHR tests update genetic risk information, the tests will not conclude that a person is at risk of developing a certain disease or condition.
Genetic variants will not lead to the development of a health condition as environmental and lifestyle factors also influence the eruption of a disease.
One major advantage of at-home DNA test will be that it can dispense with the practice of consulting a medical professional for a genetic test. The practice has been that the doctor would order a genetic test for the patients and deliver the results to them. In some cases, patients also have to visit a genetic counselor before doing a genetic test.
To use the genetic test service of 23andMe, a person only has to spit into a tube and send it to the company where the lab will work on extracting DNA from the saliva cells and look for genetic markers using a special chip.
Within two months, the customer will be informed via email that results are ready. The results can be seen online with the interpretation, which will describe risk genes as well as reports of ancestry.
In GHR tests, more than 500,000 genetic variants are searched for, which may be associated with the diseases mentioned below.
• Parkinson's Disease
• Alzheimer's Disease
• Celiac Disease
• Alpha-1 Antitrypsin Deficiency
• Early-Onset Primary Dystonia
• Factor XI Deficiency
• Gaucher Disease
• G6PD
• Hereditary Hemochromatosis
• Hereditary Thrombophilia
Meanwhile, the FDA approval has not doused the anxiety over the accuracy of GHR tests.
The website of the National Institute on Aging notes that genetic testing cannot predict a disease with 100 percent accuracy as many other factors also influence the development of diseases.
Milestone In Adoption Of Personal Genetics
The company 23andMe claimed that the FDA approval has been the recognition of its prowess in analytical testing and genotyping with high accuracy thresholds.
"This is an important moment for people who want to know their genetic health risks and be more proactive about their health," said Anne Wojcicki, 23andMe CEO and co-founder. She said it is a milestone in the adoption of personal genetics.
