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): April 4, 2012
OraSure Technologies, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-16537 | 36-4370966 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) | ||
| 220 East First Street Bethlehem, Pennsylvania |
18015-1360 | |||
| (Address of Principal Executive Offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: 610-882-1820
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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 –Regulation FD Disclosure.
On April 4, 2012, OraSure Technologies, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration’s Blood Products Advisory Committee will consider the Company’s application for the approval of its OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter market at a meeting scheduled for May 15, 2012. A copy of the press release is attached as Exhibit 99 to this Form 8-K and is incorporated herein by reference.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits
| Exhibit |
Description | |
| 99 | Press Release, dated April 4, 2012, announcing that the U.S. Food and Drug Administration’s Blood Products Advisory Committee will consider the Company’s application for the approval of its OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter market at a meeting scheduled for May 15, 2012. | |
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.
| ORASURE TECHNOLOGIES, INC. | ||||||
| Date: April 4, 2012 | By: | /s/ Jack E. Jerrett | ||||
| Jack E. Jerrett | ||||||
| Senior Vice President, General Counsel and Secretary | ||||||
Index to Exhibits
| Exhibit |
Description | |
| 99 | Press Release, dated April 4, 2012, announcing that the U.S. Food and Drug Administration’s Blood Products Advisory Committee will consider the Company’s application for the approval of its OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter market at a meeting scheduled for May 15, 2012. | |
Exhibit 99
| Investor Contact: | Media Contact: | |
| Ronald H. Spair | Ashley Buford | |
| Chief Financial Officer | GolinHarris for OraSure Technologies | |
| 610-882-1820 | 917-653-5694 | |
| investorinfo@orasure.com | abuford@golinharris.com |
FDA Sets Date for Advisory Committee Review
of OraSure Over-the-Counter Rapid HIV Test
Final phase of clinical testing to be among agenda topics for
Blood Products Advisory Committee Meeting on May 15th
BETHLEHEM, Pa., April 4, 2012 — OraSure Technologies, Inc. (NASDAQ: OSUR) today announced that the U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) will consider the Company’s application for the approval of its OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter (OTC) market at a meeting scheduled for May 15, 2012.
The Company will be presenting the findings from the final phase of clinical testing, which involved the use of the OraQuick® In-Home HIV Test, an OTC investigational use version of the OraQuick ADVANCE® Rapid HIV-1/2 test, by individuals in an unobserved setting. Approximately 5,800 subjects were enrolled and tested in this phase across 20 sites nationwide, resulting in the identification of more than 100 previously undiagnosed individuals with HIV.
“There is an urgent need for additional testing options to identify individuals who are HIV- positive, link them to care and reduce transmission of the virus,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “Our belief is that the availability of an easy-to-use, accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support.”
The meeting notice for the Blood Products Advisory Committee meeting is scheduled for publication in the Federal Register on April 5th according to a notice posted on the registry at https://www.federalregister.gov/articles/2012/04/05/2012-08167/blood-products-advisory-committee-meetings.
According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.2 million people in the U.S. who have HIV and despite current HIV testing options, approximately 240,000 of them are unaware of their status. It is estimated that those undiagnosed are responsible for up to 70 percent of the approximately 50,000 new HIV infections occurring each year in the U.S. The CDC recommends all people ages 13 to 64 be offered an HIV test in healthcare settings, with more frequent testing for people at higher risk.
OraSure currently manufactures and sells the OraQuick ADVANCE ® Rapid HIV-1/2 Test which is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in oral fluid in 20 minutes. As the market leading rapid HIV test with over 20 million tests sold, OraQuick ADVANCE ® is used extensively throughout the United States in public health settings, hospitals, community-based organizations, and physician offices where HIV testing is conducted. The OraQuick® In-Home HIV Test is an over-the-counter version of the OraQuick ADVANCE ® product currently sold into the professional market.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture and distribution of rapid point-of-care infectious disease tests, collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In addition, through its wholly-owned subsidiary, DNA Genotek Inc., the Company also is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company’s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure Technologies, please visit www.orasure.com.
The OraSure Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6440
Important Information
This press release contains certain forward-looking statements, including with respect to products, clinical studies and regulatory submissions. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to market and sell products, whether through an internal, direct sales force or third parties; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; failure of distributors or other customers to meet purchase forecasts or minimum purchase requirements for the Company’s products; impact of replacing distributors and success of direct sales efforts; inventory levels at distributors and other customers; ability to identify, complete, integrate, and realize the full benefits of potential future acquisitions, including the Company’s acquisition of DNA Genotek; impact of competitors, competing products and technology changes; impact of the economic downturn, high unemployment and poor credit conditions; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other products; changes in
market acceptance of products based on product performance, extended shelf life or other factors; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical product components; availability of related products produced by third parties or products required for use of our products; history of losses and ability to achieve sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to refinance outstanding debt under expiring credit facilities on acceptable terms or at all; ability to retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors are discussed more fully in the Company’s Securities and Exchange Commission filings, including its registration statements, Annual Report on Form 10-K for the year ended December 31, 2011, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.