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)
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
