UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in Charter)
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(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
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(Address of Principal Executive Offices) |
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Registrant’s telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
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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)) |
Indicate by a check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
7.01 – Regulation FD Disclosure.
OraSure Technologies, Inc. (“OraSure” or the “Company”) previously submitted an application to the U.S. Food and Drug Administration (“FDA”) for Emergency Use Authorization (“EUA”) for use of the OraSure SARS CoV-2 Antibody ELISA (“Antibody ELISA”) in the qualitative detection of total antibodies to SARS CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device (“Collection Device”). After reviewing the Company’s submission, the FDA requested that the Company provide additional analytical data on sample collection and stability and resubmit separate EUAs for the Antibody ELISA and the Collection Device. The Company has completed the necessary studies, collected the requested data and, on May 21, 2021, submitted applications for the separate EUAs as requested by the FDA.
Signatures
Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
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ORASURE TECHNOLOGIES, INC. |
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Date: May 26, 2021 |
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By: |
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/s/ Jack E. Jerrett |
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Jack E. Jerrett |
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Senior Vice President, General Counsel and Chief Compliance Officer |