The Wall Street Journal reports that the US Food and Drug Administration (FDA) is "clearing the first direct-to-consumer genetic test for disease risk ... signaling that it will allow a wide range of such products onto the U.S. market without agency review."
The FDA specifically is allowing 23andMe "to sell a test that consumers can use to find out whether they carry a gene variant for Bloom syndrome, a rare disease leading to stunted growth and cancer risk in their children."
The FDA decision, the story says, "is creating an easier path to market for other direct-to-consumer genetic tests, possibly including ones like Tay-Sachs disease, cystic fibrosis and sickle-cell anemia. These are higher-risk among certain ethnic populations, and members of those groups may decide to get themselves widely tested ... The decision was a surprising one for an agency that has signaled it will carefully scrutinize certain diagnostic and other disease tests produced at laboratories and hospitals, citing risks that an inaccurate reading will lead patients to make ill-advised health decisions."
The FDA specifically is allowing 23andMe "to sell a test that consumers can use to find out whether they carry a gene variant for Bloom syndrome, a rare disease leading to stunted growth and cancer risk in their children."
The FDA decision, the story says, "is creating an easier path to market for other direct-to-consumer genetic tests, possibly including ones like Tay-Sachs disease, cystic fibrosis and sickle-cell anemia. These are higher-risk among certain ethnic populations, and members of those groups may decide to get themselves widely tested ... The decision was a surprising one for an agency that has signaled it will carefully scrutinize certain diagnostic and other disease tests produced at laboratories and hospitals, citing risks that an inaccurate reading will lead patients to make ill-advised health decisions."
- KC's View:
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It is a little surprising, to be honest, that the FDA seems to have decided that at-home DNA testing kits are outside its regulatory purview. But it is not at all surprising that these kinds of products are going to go mainstream ... because this strikes me that the ability to analyze a person's DNA to determine genetic predisposition to diseases is a natural evolution in science and technology. Sure, it seemed for a time that the marketing got a little ahead of the science ... but the science will very quickly surpass the marketing, and the world will change for the better.
