Letter to Laboratory Corporation of America
DEPARTMENT OF HEALTH & HUMAN SERVICES |
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Certified Mail
Return Receipt Requested
March 2, 2004
Mr. Thomas P. MacMahon
Chairman and CEO
Laboratory Corporation of America
358 South Main Street.
Burlington, NC 27215
RE: OvaCheck - Ovarian Cancer Screen
Dear Mr. MacMahon
The Office of In Vitro Diagnostic Devices (OIVD) and the Centers
for Medicare and Medicaid Services (CMS) have reviewed materials
indicating that LabCorp is offering, or will soon offer, the OvaCheck
screening test for early-stage ovarian cancer, based on technology
licensed from Correlogic Systems, Inc.
Because the nature of this test is not clear from the materials
we have reviewed, we are uncertain if your offering of OvaCheck
is subject to regulation only by CMS, under the Clinical Laboratories
Improvement Amendments of 1988 (CLIA '88), or whether it may also require
premarket review by FDA under the Federal Food, Drug, and Cosmetic
Act. We invite you to meet with me and Ms. Judy Yost, Director of
the Division of Laboratory Services at CMS at your earliest convenience
to discuss the nature and appropriate regulatory status of the technology.
You may schedule this visit for Washington through my office (301-594-3084)
or for Baltimore through Ms. Yost’s office (410-786-3531).
We are committed to working with you as we strive to protect the
public health without unnecessarily imposing regulatory burdens
on the marketing of products of potential clinical importance.
/S/ |
/S/ |
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____________________ |
Steven Gutman, M.D
Director, Office of In Vitro Diagnostic
Device Evaluation and Patient Safety
Center for Devices and Radiological Health |
Judy Yost
Director, Division of Laboratory Services
Center for Medicare and Medicaid Services |
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