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


LabCorp warning

This article was originally published in The Gray Sheet

Executive Summary

FDA sends a warning letter to clinical lab giant Laboratory Corporation of America Sept. 29 for not obtaining clearance or approval to market its OvaSure ovarian cancer screening test, launched in June as a diagnostic service. In August, the agency had sent an "untitled" letter to LabCorp, charging the firm with marketing the test without proper clinical validation (1"The Gray Sheet" Aug. 25, 2008, p. 9). Last month, FDA officials had a face-to-face meeting with company executives. FDA typically does not enforce device review requirements for tests that are developed by a lab and offered as a service by that lab, but the warning letter points out that OvaSure was "designed, developed and validated" by Yale scientists

You may also be interested in...

FDA Questions LabCorp On Its Ovarian Cancer Test Service

FDA is charging clinical lab giant Laboratory Corporation of America with marketing a test for ovarian cancer without proper clinical validation

FDA Commissioner Nominee Hahn Advances To Full Senate, Despite Some Dems’ Reservations

Stephen Hahn, the Trump administration’s nominee to lead the US FDA, has been approved by the Senate Health, Education, Labor and Pensions (HELP) Committee, with some “no votes” from Democratic senators in leadership positions, and is expected to be considered by the full Senate this week.

FDA Holding February Public Meeting On Using AI In Radiology

The US agency will host a two-day meeting to discuss the evolution of artificial intelligence technology used to analyze radiological images when diagnosing patients and in advising radiologists to take optimal pictures. The takeaways from the meeting will be used by the FDA to help it develop its thinking on how to regulate such technology.




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