8-K

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 18, 2012 (July 16, 2012)

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 July 16, 2012, the Company issued a press release entitled “Chembio Exhibiting at 2012 AACC Annual Meeting and Clinical Lab Expo”. A copy of the press release is furnished herewith as Exhibit 99.1.

On July 17, 2012, the Company issued a press release entitled “Chembio Enters Into Six-Month $480,000 Follow-On Contract with CDC Contractor for Point-of-Care Influenza Test Development”.   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 Exhibiting at 2012 AACC Annual Meeting and Clinical Lab Expo” dated July 16, 2012.
99.2	Press Release entitled “Chembio Enters Into Six-Month $480,000 Follow-On Contract with CDC Contractor for Point-of-Care Influenza Test Development” dated July 17, 2012.

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.

July 18, 2012                                                                                      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 Exhibiting at 2012 AACC Annual Meeting and Clinical Lab Expo” dated July 16, 2012.
99.2	Press Release entitled “Chembio Enters Into Six-Month $480,000 Follow-On Contract with CDC Contractor for Point-of-Care Influenza Test Development” dated July 17, 2012.

EX-99.1

CHEMBIO EXHIBITING AT 2012 AACC ANNUAL MEETING AND CLINICAL LAB EXPO

Showcases Proprietary Point-of-Care Diagnostics and DPP Technology at Exhibit Booth #2351

MEDFORD, N.Y. (July 16, 2012) – Chembio Diagnostics, Inc. (NASDAQ: CEMI), a company that develops, manufactures, licenses and markets proprietary rapid diagnostic tests, will be exhibiting this week at the 2012 AACC Annual Meeting and Clinical Lab Expo, the largest dedicated clinicallaboratory meeting in the world.  The Expo is being held July 17-19th at the Los Angeles Convention Center with an estimated 19,000 participants and more than 700 exhibiting companies.

Exhibiting in the Clinical Lab Expo main exhibition hall at Booth #2351, the Company will be previewing sales collateral and videos that will soon be available online at the Company’s new website www.chembio.com.

Chembio will be showcasing its proprietary, patented Dual Path Platform (DPP®) technology, which enables development of point-of-care assays that provide unique features and capabilities such as multiplexing and improved control of challenging sample types like oral fluid. The Company has submitted a Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for marketing approval of its DPP® HIV 1/2 Assay, a rapid point-of-care test for the detection of antibodies to HIV 1 and 2 in oral fluid, finger-stick whole blood, venous whole blood, and serum or plasma samples, which provides a simple "reactive/non-reactive" result. Chembio anticipates the PMA to be reviewed and approved by the FDA by the end of 2012.  Several other tests have also been developed on this platform, and DPP®-based revenues are expected to grow significantly in 2012 over 2011.

“We are delighted to be highlighting our innovative line of rapid diagnostic tests at one of the industry’s premier events.  We are particularly pleased to be showcasing our DPP® HIV 1/2 Assay, as the clinical data show it can improve accuracy compared with the current lateral flow HIV test technologies,” noted Lawrence Siebert, President and Chief Executive Officer of Chembio.

“We are uniquely positioned to address the HIV self-test opportunity with our unitized Sure Check® HIV 1/2 finger-stick whole blood test,” he added.  “This test is FDA-approved for the professional market and is well established in the U.S. market by Alere as Clearview Complete HIV 1/2, and is more sensitive than the existing competitive oral fluid test.  In order to begin the regulatory process toward an over-the-counter market approval for self-testing by consumers, a company must first have a product that is FDA-approved for the professional market, making Chembio the only current practical alternative to the recently approved oral fluid self-test.  As such, we are accelerating our development plans to bring our rapid, in-home HIV test to market.”

About AACC

AACC is an international scientific/medical society of clinical laboratory professionals, physicians, research scientists and other individuals involved with clinical chemistry and related disciplines. Founded in 1948, the society has over 8,000 members and is headquartered in Washington, D.C.

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. (formerly, 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 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 170 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.  They 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

LHA

Anne Marie Fields

(212) 838-3777

AFields@lhai.com

@LHA_IR_PR

EX-99.2

Chembio Enters Into Six-Month $480,000 Follow-On Contract with CDC Contractor for Point-of-Care Influenza Test Development

MEDFORD, NY— July 17, 2012--Chembio Diagnostics, Inc. (NASDAQ: CEMI), a NY-based company that develops, manufactures, licenses and markets proprietary rapid diagnostic tests, entered into a follow-on, milestone-based development agreement of up to  $480,000 based on Chembio’s previous successful initial development of a multiplex rapid point-of-care (“POC”) influenza immunity test utilizing its patented Dual Path Platform (DPP®) technology.  The agreement contemplates a period of approximately six months in which the follow-on development activity is to be completed.

Chembio entered this agreement with a private contracting organization that is engaged to enter into, implement and provide technical oversight of agreements relating to pandemic preparedness on behalf of its client, the United States Centers for Disease Control and Prevention (“CDC”).  The previous development work for this product was completed by Chembio in 2010-11 pursuant to an initial $900,000 contract with this same organization.

The objective of this follow-on project is to further develop a rapid influenza immunity test which can be administered in the field to determine a person’s influenza immunity status or in an outpatient setting incorporating certain additional subunits of influenza virus proteins.

As a result of pandemic planning activities, the United States Department of Health and Human Services (“HHS”) and CDC identified POC and high-throughput testing as a gap in influenza diagnostics. Rapid responses in the field, such as the vaccination, prophylactic treatment, or isolation of patients, require POC diagnostic tests for influenza infection and immunity. Ideally, these tests should be fast, portable, self-contained, and non-technical. Development of these tests is especially critical for military forces, as evidenced by previous influenza outbreaks that spread rapidly through densely populated barracks and have killed thousands of soldiers

Javan Esfandiari, Chembio’s Senior Vice President of Research & Development and the inventor of DPP®, commented, “We are pleased to enter into this follow-on development program that builds on our strength in developing  multiplex products using our proprietary DPP® technology. This product could become an important diagnostic tool during influenza outbreaks.”

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. (formerly, 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 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 170 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.  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 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

LHA

Anne Marie Fields, (212) 838-3777

AFields@lhai.com

@LHA_IR_PR