Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


23andMe Launches Personal Genome Service For Carrier Screening After Work With FDA

This article was originally published in The Gray Sheet

Executive Summary

Two years of conversations with FDA have led 23andMe back to the health care market with the Oct. 21 launch of its new Personal Genome Service, focused on carrier screening tests. The firm says its close engagement with FDA has improved its customer communication and quality control.


Related Content

US FDA Implements 'Firm-Based' Regulatory Approach To DTC Genetic Health Risk Tests
FDA, 23andMe Open Up Market Pathway For DTC Genetics


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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