DTC Genetic Health Risk Tests Exempted from FDA 510 (k) Requirements Manufacturers of direct-to-consumer (DTC) genetic health risk (GHR) assessment systems were directed to withdraw pending 510 (k) ...

Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests. The letters are addressed to three ...

With the marketplace for direct-to-consumer (DTC) genetic tests showing rapid growth, cardiologists must put the information these tools produce into context before applying the results to clinical ...

† Question 1: I would get tested before pregnancy for conditions other than cystic fibrosis (through regular healthcare). † Question 2: I would get tested for carrier status of conditions other than ...

LA JOLLA, California — "If we're going to have this genomics revolution, it's going to be driven by the consumer," Anne Wojcicki, chief executive office and cofounder of 23andMe, said here at the ...

NEW YORK--(BUSINESS WIRE)--Nucleus Genomics, a next-generation consumer genetic testing and analysis company, has raised $14 million in a new funding round led by Alexis Ohanian's Seven Seven Six. The ...

A data breach at MyHeritage, an online genealogy platform and direct-to-consumer genetic testing service, exposed the email addresses and hashed passwords of 92 million customers in October.

Please provide your email address to receive an email when new articles are posted on . More than half of National Kidney Foundation respondents were unaware of genetic testing opportunities. Only 9% ...