0001092662-14-000004.txt : 20140213 0001092662-14-000004.hdr.sgml : 20140213 20140213153745 ACCESSION NUMBER: 0001092662-14-000004 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20140213 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140213 DATE AS OF CHANGE: 20140213 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: 14605716 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):  February 13, 2014 (February 10, 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 February 10, 2014, the Company issued a press release entitled "Chembio Provides Update on DPP® HIV 1/2 Assay CLIA Waiver Application".  A copy of the press release is furnished herewith as Exhibit 99.1.

On February 12, 2014,   the Company issued a press release entitled "Chembio Enters Agreements with RVR in Southeast Asia".    A copy of the press release is furnished herewith as Exhibit 99.2.

In February of 2014, the Company entered into a lease, effective March 1, 2014, for an additional 21,450 square feet of industrial space in Holbrook, New York for $14,657 per month.  The space will be utilized for offices (approximately 2,500 square feet) and warehousing (approximately 18,950 square feet).  The lease term expires on April 30, 2018.    The lease provides for annual increases of three percent each year starting March 1, 2015. 

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 Provides Update on DPP® HIV 1/2 Assay CLIA Waiver Application" dated February 10, 2014.
99.2
Press Release entitled "Chembio Enters Agreements with RVR in Southeast Asia" dated   February 12, 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.


February 13, 2014                                                                                 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 Provides Update on DPP® HIV 1/2 Assay CLIA Waiver Application" dated February 10, 2014.
99.2
Press Release entitled "Chembio Enters Agreements with RVR in Southeast Asia" dated   February 12, 2014.

 
 

EX-99.1 2 ex99_1.htm EX 99.1 PRESS RELEASE


CHEMBIO PROVIDES UPDATE ON DPP® HIV 1/2 ASSAY CLIA WAIVER APPLICATION


MEDFORD, N.Y., February 10, 2014 - Chembio Diagnostics, Inc. (NASDAQ:CEMI) a leader in point-of-care diagnostic tests for infectious diseases, today provided an update on its discussions with the U.S. Food and Drug Administration (FDA) concerning the company's CLIA waiver application for its DPP® HIV 1/2 Assay.  The DPP® HIV 1/2 Assay was approved by the FDA for professional use under an approved Pre-Marketing Application in December 2012. During 2013 untrained user studies were performed in support of a CLIA waiver application which was filed with the FDA at the end of November. During a recent discussion, the FDA indicated that additional new infections should be detected to strengthen Chembio's data that the DPP HIV-1/2 Assay performs equivalently in the hands of the untrained user as compared to the professional user.  Chembio is currently working with the FDA to define the specific additional requirements necessary for satisfactory completion of the CLIA waiver application.
The Company had anticipated that the CLIA waiver would be granted by the end of the first quarter of 2014.  The FDA's recent request will delay issuance of the waiver.  A new anticipated timetable will be announced when the Company believes it is in a reasonable position to do so.

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


EX-99.2 3 ex99_2.htm EX. 99.2 FOR PRESS RELEASE

 



CHEMBIO ENTERS AGREEMENTS WITH RVR IN SOUTHEAST ASIA
Agreements Provide Access to New Markets & Potential Cost-Effective Supplier


MEDFORD, N.Y., February 12, 2014 - Chembio Diagnostics, Inc. (NASDAQ:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that it has entered into two agreements with RVR Diagnostics SDN BHD ("RVR"), a privately-held company in Malaysia.  The agreements support Chembio's strategy of establishing a market presence in Asia, in collaboration with RVR as a licensee, distributor, and contract manufacturer.  The agreements grant exclusive distribution rights to RVR in certain countries in the region and enable RVR to manufacture Chembio's DPP® HIV 1/2 Assay and DPP® HIV-Syphilis Assay and potentially other products developed by Chembio incorporating its patented DPP® technology.
The agreements consist of a technology transfer, license and distribution agreement ("License Agreement") and also a contract manufacturing agreement ("Manufacturing Agreement").  Under the License Agreement, the parties will collaborate to allow RVR to manufacture the licensed products so that distribution activities can begin in 2015. In consideration for this work, Chembio will receive a non-refundable signature fee and, approximately one year later, a contingent fee upon validation of the transfer activity milestones.  RVR will distribute the products in the exclusive markets under license from Chembio subject to a royalty and continuing supply of reagents.  RVR is required to manufacture the DPP® HIV 1/2 Assay product in accordance with Chembio's FDA-approved specifications and plans to register its facility with the FDA. 
The Manufacturing Agreement will enable Chembio to source products from RVR's facility for shipment to Chembio's customers that are outside RVR's exclusive territory. This will provide Chembio with a new, strategically located and cost-effective capacity that will be important in serving a number of global markets including the rapidly growing Asian markets.
RVR was established in 2010 with the goal of becoming a leading supplier and distributor of high quality point-of-care diagnostic products in Asia.  RVR has been capitalized with a combination of private investment, public grants and research support from the National University of Malaysia, the country's premier university.
Javan Esfandiari, Chembio's SVP of Research & Development remarked, "We look forward to collaborating with RVR on our patented DPP® technology to support our strategy of growth in Asia, as well as RVR's commitment to provide high quality POC technology in the Asia market."

Avijit Roy, President of RVR commented, "We look forward to an exciting and bright future with Chembio in serving the Asia market."
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, to obtain regulatory approvals in a timely manner, as well as  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.

 
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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