A Bloomberg report said the clash of 23andMe Inc and the US Food and Drug Administration concerning the direct sale of the firm's gene analysis service is a sign that the oversight of the industry that is forecast to grow five times in size is set to become stricter.
Google-backed 23andMe's Personal Genome Test enables individuals to conduct an analysis of their risk in hundreds of diseases using DNA data. Hyman Phelps & McNamara Attorney Jeff Gibbs said the regulator's action last month to ban the sales of the testing kit is a suggestion that the agency is increasing its focus on tests that it has not yet regulated, the report said.
Bloomberg reported that the demand for genetic tests is growingm which would help diagnose or determine one's risk and aid in making decisions regarding treatment for diseases like cancer. James Evans, who works as a geneticist at the University of North Carolina in Chapel Hill, told Bloomberg that regulation is necessary to ensure that tests like 23andMe deliver on their claims.
In a phone interview, Evans told Bloomberg, "These tests should ultimately have to prove themselves. They should be forced to gather the evidence that backs up those claims."
The report added that insurers and government health programs like Medicare are also feeling the challenge with the advent of genetic analysis in the market. Last year, the largest health insurer in the US, UnitedHealth Group Inc, said it forecasts the national yearly spending of genetic tests to grow fivefold to $25 billion in the next decade.
Companies like closely-held Pathway Genomics Inc, which was warned by the FDA about providing estimates of genetic risks to consumers directly, form part of the industry. Pathway Genomics now provides the genetic risks estimates through doctors. Myriad Genetics, the largest provider of genetic breast and ovarian cancer diagnostic services, as well as closely-held Ambry Genetics Corp are also the other companies that make up the genetic testing industry, the report said.
Join the Conversation