UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 24, 2006
GENOMIC HEALTH, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction
of incorporation)
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000-51541
(Commission
File Number)
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77-0552594
(IRS Employer
Identification No.) |
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301
Penobscot Drive, Redwood City, California
(Address of principal executive offices)
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94063
(Zip Code) |
Registrant’s telephone number, including area code: (650) 556-9300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing
obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 8.01 Other Events.
Genomic Health, Inc. (the “Company”) announced today that it has received a letter from the
Food and Drug Administration (the “FDA”) regarding Oncotype DX™, the Company’s genomic-based test
for early stage breast cancer patients. The letter invited the Company to meet with the FDA to
discuss the nature and appropriate regulatory status of the Company’s technology and the least
burdensome ways that the Company may fulfill any FDA premarket review requirements that may apply.
The Company plans to meet with the FDA in the near future.
Oncotype DX was launched in 2004 and to date over 2,000 physicians have utilized the test in
the treatment planning for more than 7,000 breast cancer patients. Clinical laboratory services
like Oncotype DX are currently regulated under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) as administered through the Centers for Medicare/Medicaid Services, as well as by
applicable state laws. The test is performed at the Company’s Redwood City central reference
laboratory, which is accredited under CLIA and the College of American Pathology (CAP). The
Company’s licensed clinical laboratory and the Oncotype DX test cleared all required CLIA
evaluations before the first patient test was run and results reported.
As previously disclosed in the Company’s SEC filings, in December 2004, the FDA contacted the
Company regarding the regulatory status of Oncotype DX and the Company subsequently engaged in
informal communications with the FDA. In early 2005, the FDA indicated that it was considering
whether Oncotype DX may be subject to FDA premarket review.
A copy of the letter from the FDA is attached hereto as Exhibit 99.1.
Forward Looking Statements.
This current Report on Form 8-K contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s
actions in response to the FDA. Forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially, including the results of discussions with the
FDA, the status of regulation by the FDA of the Company’s products and the other risks and
uncertainties set forth in the Company’s filings with the Securities and Exchange Commission,
including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. These
forward-looking statements speak only as of the date hereof. The Company disclaims any obligation
to update these forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
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Exhibit No.
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Description |
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99.1 |
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Letter from the Food and Drug Administration dated January 23,
2006 |