FDA approves home genetic test

Local News
A test recently approved by the FDA shows whether you have a higher risk of Alzheimer’s and Parkinson’s disease, as well as several other serious conditions.
 
Just last month, the FDA agreed to allow the marketing of 23 and Me’s Genetic Health Risk Tests for ten diseases or conditions.
 
Scientists test DNA from a saliva sample for  genetic variants linked to conditions including celiac disease, blood clotting disorders,  a disorder that raises the risk of lung and liver disease, as well as Parkinson’s and Alzheimer’s.
 
A genetic counselor from Geisinger Health System says the technology gives you accurate results, but a positive finding on a test only means that you have a” slightly”  increased risk of the disease, during your lifetime.
 
“If you get a report back that says you are at an increased risk for Alzheimer’s it doesn’t mean you have Alzheimer’s, it means you have an increased chance to get it over your lifetime, so like I said maybe a couple percentage points differently, but that report would say for sure what that percentage is,” Miranda Hallquist explained.
 
And she added, “it  shouldn’t be used for treatment and care, they should be used in the context of an individual’s overall health and well-being to guide that person’s choices throughout their life, not to guide their next steps for what treatment or management would be.”
 
Hallquist said Geisinger’s genetic program called MyCode looks at the whole genome, unlike 23 and Me, which focuses on  snips of genetic material. MyCode explores 76 genes linked to heart problems, cancer,  and other diseases.
 
According to Hallquist, so far,  fewer than five percent of patients enrolled in MyCode have received significant findings. They’re offered counseling and treatment advice,  MyCode also combines test results with the medical records of patients who’ve signed up for the program.
 
Geisinger hopes to enroll at least 250,000 patients in MyCode
 

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February 07 2021 06:30 pm

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