-----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, FweKycQf1dCqgc3HejxPK+WmRCHmzCkxZaw8GT1nPaZFrdMSiRIKuoqRQ2qV6cwK NAx5NlOahBQk7srGeSW61g== 0001092662-09-000105.txt : 20091202 0001092662-09-000105.hdr.sgml : 20091202 20091202114211 ACCESSION NUMBER: 0001092662-09-000105 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20091202 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091202 DATE AS OF CHANGE: 20091202 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: 091216625 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 OF 12-1-09 form8k.htm  



 
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):  December 2, 2009 (December 1, 2009)


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 December 1, 2009, the Company issued a press release entitled “Chembio Diagnostics Donates 4,500 HIV Test Kits for World AIDS Day”.  A copy of the press release is furnished herewith as Exhibit 99.1.

On December 1, 2009, the Company issued a press release entitled “Chembio CEO Discusses Company’s HIV Testing Products on Fox News and Sirius Satellite Radio”.  A copy of the press release is furnished herewith as Exhibit 99.2.
 

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 Diagnostics Donates 4,500 HIV Test Kits for World AIDS Day” dated December 1, 2009.
99.2
Press release entitled “Chembio CEO Discusses Company’s HIV Testing Products on Fox News and Sirius Satellite Radio” dated December 1, 2009.
 


 


 
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:  December 2, 2009                                                                 Chembio Diagnostics, Inc.



By:    /s/ Lawrence A. Siebert                                      
Lawrence A. Siebert
Chief Executive Officer
 
 


 
EXHIBIT INDEX
 
Exhibit Number
Description
99.1
Press Release entitled “Chembio Diagnostics Donates 4,500 HIV Test Kits for World AIDS Day” dated December 1, 2009.
99.2
Press release entitled “Chembio CEO Discusses Company’s HIV Testing Products on Fox News and Sirius Satellite Radio” dated December 1, 2009.



 
 


EX-99.1 2 ex99_1.htm EXHIBIT 99.1 PRESS RELEASE OF 12/1/09 (1) ex99_1.htm  


 

 

 
Chembio Diagnostics Donates 4,500 HIV Test Kits for World AIDS Day

Medical Test Manufacturer Provides Point-of-Care Tests for the AIDS Healthcare Foundation’s 2009 Testing Millions Global Campaign

 MEDFORD, NY— December 1, 2009--Chembio Diagnostics, Inc. (OTC.BB: CEMI), a NY-based company that develops, manufactures, licenses and markets proprietary rapid diagnostic tests, is donating more than 4,500 rapid HIV test kits to the AIDS Healthcare Foundation’s 2009 Testing Millions Global Campaign, based in Los Angeles, to commemorate World AIDS Day 2009 on December 1st.
 
 
“It’s important to remember the need for routine testing so that AIDS patients can receive treatment,” said Lawrence A. Siebert, Chairman and CEO of Chembio.  “However, according to recent research, approximately one in five people who test positive for HIV fail to receive their results and post-test counseling.  Some of these patients who are unaware that they are infected inadvertently delay the beginning of treatment while placing others at risk of exposure.”
 
 
Siebert went on to note that rapid, point-of-care (POC) tests such as those that Chembio Diagnostics is donating to the Foundation—single test cartridges, similar to pregnancy tests, that use a small sample of blood and deliver a visual result in approximately 20 minutes—may be a solution to helping patients become aware of their test results by providing the results before the patients leave the testing site.

“We are extremely grateful that Chembio has seen fit to assist us in our efforts in this way on World AIDS Day,” said Terri Ford, senior director of global policy at the AIDS Healthcare Foundation. “Rapid point-of-care tests such as Chembio’s play a vital role in our vision for diagnosing HIV infections worldwide, and their generous gift to us of 4,500 tests is a sign of their commitment to our shared goals.”
 
 
Founded in 1985, Chembio entered the POC testing field in the late 1990s and, in 2002, focused its business to participate in the emerging global need and opportunity for rapid HIV tests.  In addition to Chembio’s two FDA-approved rapid tests for HIV, the company is developing a new generation of rapid STD tests using its patented Dual Path Platform technology.  These include a new rapid oral fluid HIV test, a unique combination screen and confirm point-of-care test for syphilis, and a rapid oral fluid hepatitis C test.
 
 
First conceived in 1987 and first celebrated the following year, World AIDS Day is dedicated to raising awareness of the AIDS epidemic caused by the spread of HIV infection.  Over one million Americans and 33 million individuals worldwide are estimated to be living with HIV.

About the AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 120,000 individuals in 23 countries worldwide in the US, Africa, Latin America/Caribbean the Asia/Pacific region and Eastern Europe. The Foundation is currently embarked on a mass global testing initiative, the ‘testing Millions’ campaign to identify and treat many of the 25 million people worldwide who do not know they are infected.  In the US, the Foundation runs specialized healthcare centers in California, Florida and Washington, DC which provide patients with up-to-date and effective treatment and services tailored specifically to them by expert HIV/AIDS medical professionals.
 
 
About Chembio Diagnostics
 
 
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio’s two FDA-approved rapid HIV tests are marketed in the U.S. by Inverness Medical Innovations, Inc. Chembio markets its HIV STAT-PAK line of rapid HIV tests internationally to government and donor-funded programs, both directly and through partnerships and 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.  Chembio’s pipeline of products incorporating this technology includes rapid tests for the screening of HIV and hepatitis C (HCV) using oral fluid samples as well as a multiplex screen and confirm rapid point-of-care diagnostic test for syphilis. Headquartered in Medford, NY, with approximately 100 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.
 

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, which reflect management's current views, are based on a number of 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:
Investor Relations:
James Carbonara, 212-825-3210

or

Media Relations:
Enrique Briz, 212-825-3210



EX-99.2 3 ex99_2.htm EXHIBIT 99.2 PRESS RELEASE OF 12/1/09 (2) ex99_2.htm  




 
CHEMBIO CEO DISCUSSES COMPANY’S HIV TESTING PRODUCTS ON FOX NEWS AND SIRIUS SATELLITE RADIO

MEDFORD, NY – December 1, 2009 – Lawrence A. Siebert, Chairman and CEO of Chembio Diagnostics, Inc. (OTC.BB:CEMI), a company that develops, manufactures, licenses, and markets proprietary rapid diagnostic tests, has appeared in interviews conducted by FOX News and Sirius Satellite Radio that were broadcast today.

The FOX News segment focused on the need and benefit of rapid HIV testing. During the segment, Mr. Siebert discussed Chembio’s rapid point-of-care HIV tests, which basically use a small sample of blood and deliver a visual result in approximately 20 minutes. Mr. Siebert also discussed Chembio’s donation of more than 4,500 rapid HIV test kits to the AIDS Healthcare Foundation’s 2009 Testing Millions Global Campaign, based in Los Angeles, to commemorate World AIDS Day 2009.  The segment can also be viewed by visiting http://video.foxnews.com/12083852/speeding-up-hiv-testing ..

The Sirius Satellite Radio segment, which aired today at 8:30 am EDT, was hosted by Dr. Kimberly DeOre on Sirius’ Doctor Radio Channel. The segment was also scheduled to coincide with World AIDS Day 2009.  Mr. Siebert once again outlined his company’s efforts to develop rapid point-of-care HIV tests and his company’s donation of tests to the AIDS Healthcare Foundation.  The segment, which will be re-broadcast tonight at 8 pm, then on Wednesday, December 2 at 2 am, and again on Friday, December 4 at 2pm, is available to Sirius and XM Satellite radio subscribers on Sirius Channel 114 and XM Channel 119. Subscribers can also listen to the segment online by visiting www.sirius.com and launching the online player. The Doctor Radio section can be found by selecting Family & Health under the channel selector.

Commenting on the interviews, Mr. Siebert said, “I am very grateful to be given these opportunities by FOX News and Sirius Satellite Radio to discuss Chembio’s outreach efforts to the community of HIV healthcare providers and patients. We believe our tests have the potential to increase awareness of the extent of HIV infection and to get patients started on the road to the care that they deserve in a more timely manner.”

About Chembio Diagnostics
 
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $5 billion point-of-care testing market. Chembio’s two FDA-approved rapid HIV tests are marketed in the U.S. by Inverness Medical Innovations, Inc. Chembio markets its HIV STAT-PAK line of rapid HIV tests internationally to government and donor-funded programs directly and through partnerships and 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.  Chembio’s pipeline of products incorporating this technology includes rapid tests for the screening of HIV and hepatitis C (HCV) using oral fluid samples as well as a multiplex screen and confirm rapid point-of-care diagnostic test for syphilis. Headquartered in Medford, NY, with approximately 100 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.

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, which reflect management's current views, are based on a number of 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:
Investor Relations:  James Carbonara, 212-825-3210

or

Media Relations: Enrique Briz, 212-825-3210 


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