0001092662-14-000023.txt : 20140325 0001092662-14-000023.hdr.sgml : 20140325 20140325144306 ACCESSION NUMBER: 0001092662-14-000023 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20140325 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140325 DATE AS OF CHANGE: 20140325 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CHEMBIO DIAGNOSTICS, INC. CENTRAL INDEX KEY: 0001092662 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 880425691 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35569 FILM NUMBER: 14715660 BUSINESS ADDRESS: STREET 1: 3661 HORSEBLOCK ROAD CITY: MEDFORD STATE: NY ZIP: 11763 BUSINESS PHONE: (631) 924-1135 MAIL ADDRESS: STREET 1: 3661 HORSEBLOCK ROAD CITY: MEDFORD STATE: NY ZIP: 11763 FORMER COMPANY: FORMER CONFORMED NAME: Chembio Diagnostics Inc. DATE OF NAME CHANGE: 20040607 FORMER COMPANY: FORMER CONFORMED NAME: TRADING SOLUTIONS COM INC DATE OF NAME CHANGE: 19990805 8-K 1 form8_k.htm FORM 8-K FOR PRESS RELEASE

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):  March 25, 2014 (March 25, 2014)


CHEMBIO DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
 
Nevada
 
0-30379
 
88-0425691
(State or other jurisdiction
 
(Commission File Number)
 
(IRS Employer
of Incorporation)
 
 
 
Identification Number)
 
 
3661 Horseblock Road
 
 
 
 
Medford, NY 11763
 
 
 
 
(Address of principal executive offices)
 
 
 
 
631-924-1135
 
 
 
 
(Registrant's Telephone Number)
 
 
 
N/A
(Former name or former address, if changed since last report)
 
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:
 
o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o  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 March 25, 2014, the Company issued a press release entitled "Chembio's HIV 1/2 STAT-PAK® Assay Receives CE Mark Approval for Rapid Point-of-Care Detection of HIV".  A copy of the press release is furnished herewith as Exhibit 99.1.


The information in this Item 7.01 of this Form 8-K is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Form 8-K also shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except to the extent that the Company specifically incorporates it by reference.


ITEM 9.01.                          FINANCIAL STATEMENTS AND EXHIBITS

Exhibits.

99.1
Press Release entitled "Chembio's HIV 1/2 STAT-PAK® Assay Receives CE Mark Approval for Rapid Point-of-Care Detection of HIV " dated March 25, 2014.
 
 

 
 


 
 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


March 25, 2014                                                                                              Chembio Diagnostics, Inc.




By:    /s/ John J. Sperzel III
John J. Sperzel III
Chief Executive Officer
 


 
 
EXHIBIT INDEX
Exhibit Number
Description
99.1
Press Release entitled "Chembio's HIV 1/2 STAT-PAK® Assay Receives CE Mark Approval for Rapid Point-of-Care Detection of HIV" dated  March 25, 2014.

 
 
 

EX-99.1 2 ex99_1.htm EXHIBIT 99.1 FOR PRESS RELEASE




Chembio's HIV 1/2 STAT-PAK® Assay Receives CE Mark Approval for Rapid Point-of-Care Detection of HIV

MEDFORD, N.Y., March 25, 2014 Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that its HIV 1/2 STAT-PAK® Assay received CE Mark approval from European regulators. The Chembio HIV 1/2 STAT-PAK® Assay is now cleared for commercialization within the European Union for rapid, POC detection of HIV. 

According to the World Health Organization (WHO), more than 1.5 million people have been diagnosed with HIV in the European Region since the start of the epidemic, including 131,000 new HIV cases in 2012. The WHO reports that in 2012, 50% of newly diagnosed HIV infections in the European Region were diagnosed late (with CD4 cell counts below 350/mm3) and 30% even later (with CD4 cell counts of 200/mm3 or lower), causing delayed initiation of antiretroviral therapy.  Based on this data the WHO reports that an increase in HIV testing and counseling needs to be scaled up in the battle against this disease.

"We believe the Chembio STAT-PAK® HIV 1/2 and SURE CHECK® HIV 1/2 Assays are important tools in the fight against HIV/AIDS. The simple test procedure, fast turnaround time, and reliable results make Chembio STAT-PAK® HIV 1/2 and SURE-CHECK® HIV 1/2 uniquely suited for clinical and outreach settings, allowing immediate patient counseling and referral," stated John Sperzel, President and CEO of Chembio.

 "In the coming months, we expect to launch the Chembio HIV 1/2 STAT-PAK® Assay and recently CE marked Chembio SURE CHECK® HIV 1/2 Assays in Europe.  In addition, we continue to work with regulators in Europe to obtain CE Marks for the Chembio DPP® HIV 1/2 Oral Fluid test and the Chembio DPP® HIV-Syphilis test," added Sperzel.

About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $10 billion point-of-care testing market. Chembio's two FDA PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by Alere, Inc.  Chembio markets its HIV STAT-PAK® line of rapid HIV tests internationally to government and donor-funded programs directly and through distributors. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP®.  Headquartered in Medford, NY, with approximately 200 employees, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485. For more information, please visit: www.chembio.com.
Forward-Looking Statements
Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.


CONTACTS:                         Chembio Diagnostics
Susan Norcott
(631) 924-1135, ext. 125
snorcott@chembio.com

                                                    Vida Strategic Partners (investors)
Stephanie C. Diaz
                                               (415) 675-7401
sdiaz@vidasp.com
 
 

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