HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA Points To Premarket Clearance For Direct-To-Consumer Genetic Tests

This article was originally published in The Tan Sheet

Executive Summary

FDA tells direct-to-consumer genetic testing company 23andMe that it should immediately stop marketing its Personal Genome Service in a strongly worded, lengthy warning letter that experts say could provide guidance across the sector. The firm says it will address the agency’s concerns.

You may also be interested in...

510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014

CDRH says it plans to release the 510(k) program final guidance as well as the anticipated in vitro companion diagnostic final guidance next year. The device center has divided the 22 forthcoming guidance documents into an “A-list” and a “B-list,” based on its priorities and allocated resources.

23andMe Launches TV Ad Campaign For DTC Gene Testing Service While Seeking 510(k)

The seller of a $99 direct-to-consumer genetic test service is running ads with actors discussing the values of learning one’s personal DNA profile. But the firm’s continued marketing of the testing services and now its high-profile ads may raise questions about the regulatory status of its offerings.

FDA To Regulate Direct-To-Consumer Genetic Tests

FDA sent letters to five genetic testing firms requesting pre-market submissions for the companies' already-marketed services, citing the need to prove that direct-to-consumer genetic assays are analytically and clinically accurate


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts