US regulators are moving to stop sales of Google-backed 23andMe’s landmark product, Saliva collection DNA kits, because they have not cleared sufficient tests for license approval.
Saliva Collection DNA kits are currently sold directly to the public via 23andMe‘s website for $99. Since the kits help people assess their risk of cancer, heart disease and other medical conditions, they fall into a category classed as a medical device, requiring FDA approval.
“FDA is concerned about the public health consequences of inaccurate results from the PGS device. The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work,” they said.
Within a decade the DNA testing market is projected to become a $25 billion annual market.
