Medtech 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


Hill scrutinizes genetic testing firms

This article was originally published in The Gray Sheet

Executive Summary

House Energy and Commerce Committee is investigating three firms that market personalized genetic testing directly to consumers following a high-profile announcement and reversal by Pathway Genomics earlier this month on plans to start selling its test collection kits at Walgreens retail outlets. Bipartisan leaders of the committee sent letters May 19 to 1Pathway, 223andMe and 3Navigenics, each of which sell genetic test sampling kits and testing services via the Internet, requesting documentation in support of the accuracy of the testing services, of sufficient staff training, of appropriate procedures for providing results to patients and handling DNA samples, and of compliance with FDA regulations. Walgreens delayed plans to carry Pathway's sampling kits after FDA made a public case that the firm was bucking agency regulations by offering the kits and services without approval (4"The Gray Sheet" May 17, 2010)

You may also be interested in...

FDA Cites Long-Term Precedent In Blocking Retail Genetic Screening Plans

A particularly public preemptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans last week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests

Bellwether Wuxi Biologics' Plunge Indicative Of China Biotech Challenges

Major Chinese biopharma contract services group WuXi Biologics' share price plummeted after it said external factors would contribute to it missing original revenue targets this year in multiple areas.

Cosmetic And Personal Care Weekly Trademarks Review: 5 December

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.


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