FDA approves new gene carrier test for ten diseases
Many diseases are hereditary, and those with a family medical history of genetic diseases are at high risk for these conditions. Different genetic tests can help determine the likelihood of genetic disorders based on ethnic descent, such as prenatal testing undergone by couples before pregnancy.
But can a at-home test diagnose being a carrier for genetic disorders, and even multiple genetic diseases? The U.S. Food and Drug Administration (FDA) has recently approved a direct-to-customer test that could be a game changer. Meet the test that could change the world of medicine.
The test approved by the FDA was developed by 23andME (one of the company’s investors is Google). This groundbreaking at-home test can allow users to find out their genetic risk level for ten different diseases.
The test assesses the genetic risk for the following diseases: Parkinson’s disease, Alzheimer’s disease, Celiac disease, Alpha-1 antitrypsin deficiency, Factor XI deficiency, Gaucher type 1, Early-onset primary dystonia, Hereditary thrombophilia, Bloom syndrome, and G6PD deficiency. These diseases may not all be well known to those who are not doctors, but the known diseases among the ten are considered severe conditions.
The test is relatively easy to take. All that is required is a saliva sample, which is then mailed to the enclosed address. This means that technically, the interpretation is done in a laboratory in the United States and not at home, as one might assume from the new announcements. It is still a relatively simple process, that does not require leaving one’s home apart from a quick stop at the postal service.
After several weeks, an envelope with the detailed results of the genetic interpretation. The bottom line of these results is the genetic risk level for diseases the designated diseases.
It should be noted that the test does not determine whether one is a carrier and does not diagnose the diseases, since this requires more advanced technologies. The test can help understand the probability of developing a disease, which can help preparation such as undergoing further more frequent tests to detect the disease in its early stages.
What does the future hold?
The FDA approval relates to the test’s credibility and precision and means it is suitable for use. The FDA is now working towards approving more kits that can give answers regarding other diseases. It can be interesting to see if soon, tests will eliminate the human factor enable interpreting test results without the need for healthcare professionals.
Today, there are concerns of incorrect interpretation of the tests when not performed by professionals, despite the available information online.
However, this test is just the beginning. Time will tell if most screen testing, and particularly genetic testing, will be performed at home and make matters simpler. Either way, this is outstanding news for people with a family history of genetic diseases, and for those who are concerned and want to know they are at low risk for different diseases.
