Bradley Merrill Thompson Quoted in “UPDate 1-Gene Startup 23andme Casts Eyes Abroad After U.S. Regulatory Hurdle”

Reuters

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC office, was quoted in an article titled "UPDate 1-Gene Startup 23andme Casts Eyes Abroad After U.S. Regulatory Hurdle"

Following is an excerpt:

Genetics startup 23andme is forging ahead with plans to sell its full-fledged test kit, but will focus on overseas markets after facing regulatory hurdles at home from the U.S. Food and Drug Administration. ?...

The Google Inc -backed firm is targeting English-speaking markets, with Australia, Canada and Britain the most likely contenders. ?...

Last year, 23andme agreed to stop selling its $99 DNA test in the United States until it obtained marketing authorization from the FDA. In a public warning letter, the FDA said it feared false positive or false negative results from the genetic test could prompt patients to take "morbidity inducing" actions, like unnecessary surgery. ?...

Bradley Merrill Thompson, a Washington D.C.-based attorney with Epstein Becker Green, said Canada is a logical choice for health entrepreneurs because of its affluent health system and clear regulatory guidelines.

"But in most countries, regulators will be concerned about whether 23andme's medical prediction would trigger actions," said Merrill Thompson, who counsels clients on FDA regulatory issues.