-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DVOYGihCZ0Q7sO033JQuzc0zMkkWyjOlqu4Rx3slWL69vbv8GTTHT1svc3pGwq03 Neg5LxErtNZHAC9rFrQbZQ== 0001092662-06-000062.txt : 20060714 0001092662-06-000062.hdr.sgml : 20060714 20060714165841 ACCESSION NUMBER: 0001092662-06-000062 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060710 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060714 DATE AS OF CHANGE: 20060714 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: 000-30379 FILM NUMBER: 06963129 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 form8k.htm FORM 8-K FOR PRESS RELEASES Form 8-K for Press Releases




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) July 10, 2006

CHEMBIO DIAGNOSTIC, 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 Disclosures.

 
(a)
On July 10, 2006 the Registrant issued the press release titled “Chembio to Present at the 2006 C.E. Unterberg Towbin Emerging Growth Opportunities Conference” included herein as Exhibit 99.1.

 
(b)
On July 12, 2006 the Registrant issued the press release titled “Chembio Submits CLIA Waiver Application for HIV 1/2 Stat-Pak(TM)” included herein as Exhibit 99.2.

ITEM 9.01. Financial Statements and Exhibits
 
(c) Exhibits.


99.2
Press Release titled “Chembio Submits CLIA Waiver Application for HIV 1/2 Stat-Pak(TM)” issued July 12, 2006.
 

 
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.


Date: July 14, 2006    Chembio Diagnostics, Inc.
 
By:    /s/ Lawrence A. Siebert  
Lawrence A. Siebert
Chief Executive Officer
 
 


EX-99.1 2 ex99-1.htm EXHIBIT 99.1 PRESS REALSE OF 7/10/06 Exhibit 99.1 Press Realse of 7/10/06


Press Release of 7/10/06
 


Chembio to Present at 2006 C.E. Unterberg Towbin
Emerging Growth Opportunities Conference

MEDFORD, N.Y. - July 10, 2006 - Chembio Diagnostics Inc.’s (OTCBB: CEMI) Chairman and President, Lawrence Siebert, will present at the 2006 C.E. Unterberg Towbin Emerging Growth Opportunities Conference on Wednesday, July 12th at 3:12 PM (EST) at New York City’s Mandarin Oriental Hotel. A live webcast of the presentation will be available on the Company’s website at www.chembio.com. Additional information regarding the conference can be found at www.unterberg.com.

Mr. Siebert will speak about the market opportunities for the Company’s rapid diagnostic tests for infectious diseases and the positive effect that government funding, treatment goals, and CDC routine testing recommendations are having towards worldwide demand. He will also discuss Chembio’s other infectious disease rapid tests and the Company’s new rapid test platform, the Dual Path Platform (DPP(TM)), the platform for a new oral fluid based rapid HIV test the Company is developing.
 
ABOUT CHEMBIO
 
Chembio Diagnostics, Inc. possesses expertise in the development and manufacturing of rapid diagnostic tests for various infectious diseases. Chembio is participating in the frontlines of the global battle against the devastating AIDS pandemic. This battle, to which the United States alone has pledged $15 billion in international aid, is the impetus behind Chembio's rapid HIV tests. Because rapid tests can detect HIV antibodies within minutes, the massive prevention and treatment programs that are now scaling up can be much more effective. The Company has received marketing approval from the FDA for its SURE CHECK(R) HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid tests . The Company also manufactures additional rapid tests that it has developed for other deadly diseases, including human and veterinary Tuberculosis and Chagas Disease and has developed a patent-pending platform, the Dual Path Platform (DPP(TM)) for its next generation HIV and other rapid tests. References to Chembio Diagnostics, Inc. may actually refer to Chembio Diagnostic Systems, Inc., the wholly owned subsidiary of Chembio Diagnostics, Inc. Chembio is located at 3661 Horseblock Road, Medford, NY 11763. For additional 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, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements 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, to obtain regulatory approvals in a timely manner, and 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.
 
Contact:
The Investor Relations Group
Investors: James Carbonara/Andrea Raetzer
Media: Judy Katz/Susan Morgenbesser
212-825-3210


EX-99.2 3 ex99-2.htm EXHIBIT 99.2 PRESS RELEASE OF 7/12/06 Exhibit 99.2 Press Release of 7/12/06


Exhibit 99.2 Press Release of 7/12/06
 


 
Chembio Submits CLIA Waiver Application for HIV 1/2 Stat Pak (TM) Potential Customers: 189,000 Doctor’s Offices and Clinics

MEDFORD, N.Y. July 12, 2006-Chembio Diagnostics Inc. (OTCBB: CEMI) has submitted a CLIA Waiver Application for the Chembio HIV 1/2 STAT-PAK(TM) rapid diagnostic test on July 7th, 2006. The CLIA waiver, if granted, will allow Chembio to market to approximately 189,000 laboratory entities across the United States, including doctors’ offices and clinics.

Chembio received marketing approval for its HIV 1/2 STAT-PAK(TM) from the U.S. Food and Drug Administration’s Center for Biologics and Research (CBER) on May 25th, 2006. That approval is a prerequisite to submitting the CLIA Waiver. The test is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2.

Larry Siebert, Chief Executive Officer states, “In view of new recommendations by the United States Centers for Disease Control that HIV tests become a part of routine medical care for most Americans, the CLIA waiver, once it is granted, would enable Chembio to provide its tests to doctors’ offices and clinics, where much of this testing would be taking place.”

The Company also expects this year to submit an application for CLIA Waiver for its SURE CHECK(R) HIV 1/2, which also received marketing approval from the FDA’s CBER.

ABOUT CHEMBIO
Chembio Diagnostics, Inc., a developer and manufacturer of rapid diagnostic tests for infectious diseases, is on the frontlines of the global battle against the AIDS pandemic. The Company has received marketing approval from the FDA for its SURE CHECK(R) HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid tests. The Company also manufactures rapid tests for veterinary Tuberculosis and Chagas Disease, and has developed a patent-pending technology, the Dual Path Platform (DPP(TM)), for its next generation HIV and other rapid tests. For additional 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, as the Company has not completed the preparation of its financial statements for those periods, nor has its auditor completed the audit of those results. Actual revenue may differ materially from those anticipated in this press release. Such statements 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, to obtain regulatory approvals in a timely manner, and 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.
 
Contact:
The Investor Relations Group
Investors: James Carbonara/Andrea Raetzer
Media: Susan Morgenbesser
212-825-3210


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