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

UsernamePublicRestriction

Sequenom Addresses Problems With Tainted Data; CEO Fired

This article was originally published in The Gray Sheet

Executive Summary

Sequenom will rely on independent third-party validation of all future tests after an investigation into SEQureDX Down syndrome test R&D data revealed mishandling by employees

You may also be interested in...



FDA Aims To Finalize Framework For Lab-Developed Tests In Near Term

FDA could have a final framework in place for overseeing a greatly expanded range of laboratory test services within months of a public meeting scheduled for July, according to agency officials

FDA Aims To Finalize Framework For Lab-Developed Tests In Near Term

FDA could have a final framework in place for overseeing a greatly expanded range of laboratory test services within months of a public meeting scheduled for July, according to agency officials

Sequenom settles shareholder suit

Firm announces Jan. 15 it will pay $14 million to resolve a class action shareholder suit related to employee mishandling of its SEQureDX Down syndrome test data. Subject to final approval by the U.S. District Court for the Southern District of California, the firm will also issue to the class members and their attorneys 9.95% of its common stock outstanding. Former Sequenom CEO Harry Stylli, CFO Paul Hawran and Senior VP-Research and Development Elizabeth Dragon also have entered into the settlement. Sequenom fired Stylli and Dragon, and Hawran resigned, after an independent investigation revealed the firm failed to put in place adequate protocols and controls for the conduct of studies in the Down syndrome test program, leading to errors in data and inadequately substantiated claims (1"The Gray Sheet" Oct. 5, 2009)

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT028005

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

Cancel