Medtech Insight is part 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

UsernamePublicRestriction
UsernamePublicRestriction

FDA To Regulate Direct-To-Consumer Genetic Tests

This article was originally published in The Gray Sheet

Executive Summary

Citing the need to prove that direct-to-consumer genetic assays are analytically and clinically accurate, CDRH sent letters to five genetic testing firms June 10 requesting pre-market submissions for the companies' already-marketed services

You may also be interested in...



DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says

The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.

What's Next For LDTs? FDA May Be Eyeing A New Game Plan

Following the agency's signal to stakeholders that it will not be finalizing a regulatory framework for laboratory-developed tests this year, industry experts suggest some other approaches FDA could take to address lab tests of all stripes.

Pathway Genomics Remains In FDA Crosshairs For Genetic Testing Service

An untitled letter from FDA targets Pathway Genomics' recent launch of a cancer screening assay that FDA says is being marketed directly to consumers without proper FDA review.

Related Content

Topics

UsernamePublicRestriction

Register

MT028996

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

Cancel