0001092662-14-000074.txt : 20141028 0001092662-14-000074.hdr.sgml : 20141028 20141028161307 ACCESSION NUMBER: 0001092662-14-000074 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20141028 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20141028 DATE AS OF CHANGE: 20141028 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: 141177284 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):  October 28, 2014 (October 27, 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 October 27, 2014, the Company issued a press release entitled "Chembio Partners with Integrated BioTherapeutics, Inc. to Develop Point-of-Care Diagnostic Tests for Ebola and Febrile Illness".  A copy of the press release is furnished herewith as Exhibit 99.1.

On October 28, 2014, the Company issued a press release entitled "Chembio Announces Agreements to Develop Point-of-Care Diagnostic Tests for Dengue Fever Virus and a Specific Type of Cancer".  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 Partners with Integrated BioTherapeutics, Inc. to Develop Point-of-Care Diagnostic Tests for Ebola and Febrile Illness" dated October 27, 2014.
99.2
Press Release entitled "Chembio Announces Agreements to Develop Point-of-Care Diagnostic Tests for Dengue Fever Virus and a Specific Type of Cancer" dated October 28, 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.


October 28, 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 Partners with Integrated BioTherapeutics, Inc. to Develop Point-of-Care Diagnostic Tests for Ebola and Febrile Illness" dated October 27, 2014.
99.2
Press Release entitled "Chembio Announces Agreements to Develop Point-of-Care Diagnostic Tests for Dengue Fever Virus and a Specific Type of Cancer" dated October  28, 2014.

 
 
 EX-99.2 2 ex99_2.htm EXHIBIT 99.2 FOR PRESS RELEASE



Chembio Announces Agreements to Develop Point-of-Care Diagnostic Tests for Dengue Fever Virus and a Specific Type of Cancer
 

MEDFORD, NY, October 28, 2014 -- Chembio Diagnostics, Inc. (NASDAQ:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that on October 27, 2014 it entered into an agreement to develop a POC diagnostic test for dengue fever virus.  The Company also announced that it has entered into an agreement with an international diagnostics company to develop a POC diagnostic test for a type of cancer.  Both development projects will incorporate Chembio's patented DPP® technology.  Under the terms of the agreements, financial details and the names of the collaborators are not being disclosed.
Javan Esfandiari, Chembio's Chief Science & Technology Officer and the inventor of the DPP® technology, commented, "We are pleased to enter into the agreement to develop a DPP® Dengue Fever Assay, which would be able to detect IgG/IGM and NS1 antigens. Based on our 2013 experience developing a DPP® Febrile Illness Assay in partnership with a U.S. government agency, we are confident in our ability to develop a stand-alone DPP® Dengue Fever Assay. We are also pleased to work with a leading diagnostics company to develop a state-of-the-art test for the early detection and monitoring of a specific type of cancer. The cancer project represents the first application of the DPP® technology outside of the infectious disease field and it is our hope that bringing the DPP® technology to the oncology market will aid in improving outcomes for patients battling cancer."
The DPP® point-of-care technology was developed at Chembio, granted initial patent protection in 2007, and has been successfully commercialized as two infectious disease products: DPP® HIV 1/2 Assay and DPP® HIV-Syphilis Combination Assay. The DPP® technology offers a significant advantage over traditional lateral flow technology, as it provides increased sensitivity and the ability to offer multiple test results with a single patient sample.

John Sperzel, Chembio's Chief Executive Officer, commented, "The World Health Organization estimates there are 3 billion people living in dengue endemic countries, and the CDC estimates there are 400 million dengue virus infections annually, making dengue virus a leading cause of illness and death in the tropics and subtropics. We believe a stand-alone DPP® Dengue Fever Assay and a dengue fever test as part of a DPP® Febrile Illness Assay, will be useful tools in combating this deadly disease. We also believe the DPP® technology has application in other clinical areas, and we are thrilled that an industry collaborator has recognized the potential value of DPP® within the oncology market."

Chembio's products are manufactured in the US by Chembio. For more information on any Chembio-branded products, please contact our customer service team at 1.844.CHEMBIO or visit us at:  www.chembio.com.


 
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP® HIV 1/2 Assay and HIV 1/2 STAT-PAK® Assay in the U.S. and internationally. The Company's SURE CHECK® HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview® Complete. Outside the U.S., Chembio markets its SURE CHECK® HIV 1/2 Assays 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.
Headquartered in Medford, NY, 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 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. 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, which 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 (investor relations)
Stephanie C. Diaz
(415) 675-7401
sdiaz@vidasp.com

Vida Strategic Partners (media)
Tim Brons
(415) 675-7402
tbrons@vidasp.com

 
 
 EX-99.1 3 ex99_1.htm EXHIBIT 99.1 FOR PRESS RELEASE




Chembio Partners with Integrated BioTherapeutics, Inc. to Develop Point-of-Care Diagnostic Tests for Ebola and Febrile Illness
  
MEDFORD, NY, October 27, 2014 – Chembio Diagnostics, Inc. (NASDAQ:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has entered into an exclusive agreement with Integrated BioTherapeutics, Inc. (IBT), a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases.  Under the terms of the agreement, Chembio will combine its patented DPP® technology with IBT's proprietary Ebola reagents to develop POC diagnostic tests for Ebola and febrile illness.  Chembio will have exclusive rights to any POC product developed through this agreement.  Financial terms of the agreement were not disclosed.
While Ebola has caused multiple outbreaks since 1976, the frequency of epidemics in the past 15 years has drastically increased and the current outbreak in West Africa has reached unprecedented dimensions.  Over 10,000 people have been infected with Ebola and recent cases outside the African continent are drawing concern from public health officials.  Currently, the diagnosis of Ebola hemorrhagic fever can only be performed in specialized laboratories.  This limitation significantly delays the identification and isolation of the patients who have Ebola and in turn likely makes it more difficult to control an outbreak or prevent new epidemics.
Javan Esfandiari, Chembio's Chief Science & Technology Officer and the inventor of Chembio's DPP® technology, commented, "We are pleased to partner with IBT, a biotechnology company with extensive experience and a substantial number of reagents for Ebola and other filoviruses, to develop a DPP® Ebola assay.  In 2013, we partnered with the U.S. Government to develop a multiplex POC febrile illness assay which, in 20 minutes, can detect antigens from five different viruses, bacteria, and parasites with a single, finger-stick drop of blood.  The resulting product, DPP® Febrile Illness Assay, is currently in clinical trials in several countries, including the region of West Africa.  Our intent is to develop a stand-alone POC DPP® Ebola test and also include an Ebola test as part of our existing multiplex DPP® Febrile Illness Assay."
John Sperzel, Chembio's Chief Executive Officer, commented, "The partnership with IBT is a significant step in our continued efforts to expand Chembio's POC infectious disease portfolio.  Our prior success developing the multiplex DPP® Febrile Illness Assay demonstrates Chembio's ability to create such tests in a short amount of time, and we believe this partnership illustrates the value that our DPP® technology brings to the broader diagnostic market.  Through this agreement, Chembio's goal is to further develop innovative, sensitive and specific POC diagnostic tests for detection of febrile illnesses, including Ebola."
M. Javad Aman, President and Chief Scientific Officer of IBT, commented, "We are facing a humanitarian crisis and global public health challenge.  Development of a rapid POC test for Ebola will be a critical step towards enabling early detection and quarantine that could help save countless lives.  Through this partnership, the capabilities of the two companies will be combined to produce a POC product we believe will meet this serious challenge in a timely manner."
Chembio is represented by Squire Patton Boggs (US) LLP and IBT is represented by Crowell & Moring LLP in this transaction.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP® HIV 1/2 Assay and HIV 1/2 STAT-PAK® Assay in the U.S. and internationally. The Company's SURE CHECK® HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview® Complete. Outside the U.S., Chembio markets its SURE CHECK® HIV 1/2 Assays 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.
Headquartered in Medford, NY, 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 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com
About Integrated BioTherapeutics, Inc.
Integrated BioTherapeutics, Inc. (IBT) is a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases.  IBT's pipeline includes product candidates for several bacterial and viral infections including vaccines and immunotherapeutics for Ebola and other filoviruses, a multivalent vaccine for staphylococcal infections, and immunotherapeutics for Hepatitis C Virus. For more information, please visit http://www.integratedbiotherapeutics.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, which 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 (investor relations)
Stephanie C. Diaz
(415) 675-7401
sdiaz@vidasp.com

Vida Strategic Partners (media)
Tim Brons
(415) 675-7402
tbrons@vidasp.com
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