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):  June 21, 2011 (June 27, 2011)

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 June 21, 2011, the Company issued a press release entitled “Chembio Updates 2011 FIOCRUZ Revenue Outlook”.   A copy of the press release is furnished herewith as Exhibit 99.1.

On June 22, 2011, the Company issued a press release entitled “Chembio Updates 2011 FIOCRUZ Revenue Outlook”.  A copy of the press release is furnished herewith as Exhibit 99.2.

Additionally, on June 27, 2011, the Company issued a press release entitled “Chembio Initiates Pre-IDE Studies for Home Use of Sure Check® Rapid HIV Test “.  A copy of the press release is furnished herewith as Exhibit 99.3.

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 Expands Board of Directors” dated June 21, 2011.
99.2	Press Release entitled “Chembio Updates 2011 FIOCRUZ Revenue Outlook” dated June 22, 2011.
99.3	Press Release entitled “Chembio Initiates Pre-IDE Studies for Home Use of Sure Check® Rapid HIV Test” dated June 27, 2011.

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.

June 27, 2011                                                                 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 Expands Board of Directors” dated June 21, 2011.
99.2	Press Release entitled “Chembio Updates 2011 FIOCRUZ Revenue Outlook” dated June 22, 2011.
99.3	Press Release entitled “Chembio Initiates Pre-IDE Studies for Home Use of Sure Check® Rapid HIV Test” dated June 27, 2011.

EX-99.1

CHEMBIO EXPANDS BOARD OF DIRECTORS

MEDFORD, N.Y (June 21, 2011) – Chembio Diagnostics, Inc. (OTC.QB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, has appointed Barbara A. DeBuono, M.D., M.P.H., and Peter Kissinger, Ph.D., to its Board of Directors, effective July 1, 2011.

Barbara A. DeBuono, M.D., M.P.H. is a renowned expert in public health innovation, health policy, education and research. In May 2011, Dr. DeBuono was appointed President and CEO of ORBIS International, which is dedicated to saving sight and eliminating avoidable blindness worldwide with headquarters in New York City.  Previously, from 2009-2011, Dr. DeBuono was Chief Medical Officer, Partner and Global Director of Health and Social Marketing at Porter Novelli, and from 2000-2008 she was Executive Director, Public Health and Government at Pfizer Inc.  Dr. DeBuono has served as Commissioner of Health for the state of New York and as Director of Health in Rhode Island and she was honored by the CDC Foundation in 2005 as one of five Public Health Heroes nationwide.  She serves as adjunct professor at The George Washington University School of Public Health, and is a co-founder of The MAIA Foundation, a charity dedicated to women’s health in sub-Saharan Africa. A Fellow of the American College of Physicians, Dr. DeBuono received her B.A. from the University of Rochester, her M.D. from the University of Rochester School of Medicine, and a Masters in Public Health (M.P.H.) from Harvard University School of Public Health.

Peter Kissinger, Ph.D., is a scientist, entrepreneur and academic, with a multi-faceted career in biotechnology and biomedical technologies.  He is the founder and Chairman Emeritus of Bioanalytical Systems, Inc. (NASDAQ: BASI), served as its Chairman and CEO from 1974-2007, and is Professor of Chemistry and Associate Department Head at Purdue University, West Lafayette, Indiana.  Dr. Kissinger’s academic research has involved the study of modern liquid chromatography techniques, and in vivo methodology for drug metabolism and the neurosciences.  Dr. Kissinger has published more than 230 scientific papers and is a Fellow of the American Association of Pharmaceutical Scientists and the American Association for the Advancement of Science.  In 2005, he became the Chairman of Prosolia, which markets mass spectrometry innovations for life science, industrial and homeland security applications.  In 2007, he and Candice Kissinger founded Phlebotics, Inc., a medical device company focused on diagnostic information for intensive care medicine. He is a columnist for the trade publication Drug Discovery News. Dr. Kissinger received a B.S. in Chemistry from Union College, Schenectady, N.Y. and a Ph.D. in Analytical Chemistry from the University of North Carolina in Chapel Hill.

Lawrence A. Siebert, Chembio’s Chairman and CEO, remarked, “On behalf of our current board of directors, I welcome both Dr. DeBuono and Dr. Kissinger and their service to our board of directors”.

Engagement of BDO USA, LLP as Company’s Independent Accountants

As recently reported in an 8-K filing with the SEC, the Company has made a change in its independent accounting firm and engaged BDOUSA, LLP (“BDO”).  Lawrence Siebert commented, “BDO is one of the leading accounting firms with a strong presence locally and globally. We look forward to working with them.  We also appreciate the service of our previous accountants.”

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $7 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 known as 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 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, and actual results 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.

Contacts:

Company: Contact:

Susan Norcott 631-924-1135 x125 or snorcott@chembio.com

Investor & Public Relations

The Investor Relations Group

212-825-3210

James Carbonara JCarbonara@investorrelationsgroup.com

Orbis International

Jennifer Berman

Associate Director, Communications

ORBIS International

P: 646.674.5532

Jennifer.Berman@orbis.org

EX-99.2

CHEMBIO UPDATES 2011 FIOCRUZ REVENUE OUTLOOK

MEDFORD, N.Y (June 22, 2011) – Chembio Diagnostics, Inc. (OTC.QB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, is providing an update on the revenues anticipated from the Oswaldo Cruz Foundation, (“FIOCRUZ”) during the remainder of 2011.  As reported by Chembio on May 5, 2011, the Company had received orders for all four of the products approved thus far pursuant to its agreements with FIOCRUZ and that it would provide an update of its anticipated shipments to FIOCRUZ when possible.

Recently FIOCRUZ informed Chembio of the schedule it has established with Brazil’s Ministry of Health for the introduction of these products. Based on that schedule and the corresponding requested delivery dates Chembio has received from FIOCRUZ, the Company currently anticipates that it will realize at least $3 million in Net Sales with respect to these products during the balance of 2011, including at least $600,000 in the current quarter. The Company may update this information from time to time, for example when the Company files its quarterly financial reports.

During 2008 and 2010 Chembio entered into five agreements with FIOCRUZ for five DPP® products which  Chembio had developed or would develop and which FIOCRUZ and the Ministry of Health of Brazil believe would be essential to better serve the needs of the public health sector in Brazil.  During 2010 and 2011 year to date, FIOCRUZ has received regulatory approval (ANVISA & MAPA) for distributing four of the five products under these agreements, a fifth approval is pending.

A recent news clip featuring the DPP® HIV 1&2 Confirmatory test being launched by FIOCRUZ can be viewed at http://www.band.com.br/jornaldaband/conteudo.asp?ID=100000439673 .

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $7 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 known as 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 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, and actual results 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.

Contacts:

Company: Contact:

Susan Norcott 631-924-1135 x125 or snorcott@chembio.com

Investor & Public Relations

The Investor Relations Group

212-825-3210

James Carbonara JCarbonara@investorrelationsgroup.com

EX-99.2

Chembio Initiates Pre-IDE Studies for Home Use of Sure Check® Rapid HIV Test

MEDFORD, NY -- June 27, 2011 -- Chembio Diagnostics, Inc. (OTC.QB: CEMI) (“Chembio” or the “Company”), which develops, manufactures, markets and licenses point-of-care diagnostic tests, has initiated studies required for submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration for its Sure Check® rapid HIV Test as the first step toward over-the-counter (OTC) product approval.  This is the first of Chembio’s FDA-approved rapid HIV tests that it will target for the at-home market.

The first step toward approval is to submit an investigational device exemption (IDE).  Chembio believes that a market study of the intended users and an additional “Flex” Study are required to complete the IDE submission. Both of these studies have been initiated and Chembio plans to complete both of these studies and submit an IDE to the FDA during the latter part of this year. Chembio will be requesting a meeting with the FDA to confirm and further clarify the process prior to submitting an IDE.

Lawrence Siebert, CEO of Chembio Diagnostics, commented, “Today is National HIV Testing Day, and it is important to realize that the need for a simple at-home rapid HIV test is still unfulfilled. Approximately 20 percent of Americans with HIV are unaware of their infected status according to the CDC.  Our test will empower individuals who don’t have access to point-of-care testing, or who are afraid to take the test in a public setting, to get the information they need to make  informed decisions, including getting early access to increasingly effective therapeutic treatments.  We believe that our Sure Check® HIV system is convenient, cost effective and reliable, and that by addressing this additional market segment we will help to achieve the important public health objective of increasing awareness of HIV status.”

The Sure Check® HIV test is a finger-stick whole blood test that is unique in how easy it is to use and provides results in just 15 minutes.  This is by no means the first at-home test that uses blood samples; many diabetes and coagulation monitoring tests currently use blood samples.  Chembio believes that its test will be as acceptable to the general public as these other tests that have been widely used in the home testing market.

Chembio’s Sure Check® HIV test uses a “barrel” system that is easy to use and should be accepted for self-testing based upon its growing success in the professional market, such as public health testing clinics.  The barrel system contains a sample port at one end of the barrel which houses the HIV test strip.  The small blood sample (only 2.5 micro liters required) enters the barrel simply by touching the sample port to the fingertip pricked with the provided safety lancet.  The “barrel” technology confines the sample and reagents, thereby minimizing potential exposure to the user or other parties.  [For more information see http://www.chembio.com/humantest3.html ]

Sure Check® HIV received FDA approval for professional use on May 25, 2006 and was granted CLIA waiver status in 2007.  The HIV 1/2 Stat-Pak® Assay, Chembio’s other FDA-approved lateral flow rapid HIV test, also received approval for hospitals and clinics on May 25, 2006.  To date, these represent two of the four FDA-approved rapid HIV tests in the U.S. market.  Chembio’s patented Dual Path Platform (DPP®) HIV test, for use with oral fluid or blood samples, is currently in clinical trials.   Also in development with Chembio’s DPP® technology are DPP® Syphilis, DPP® Hepatitis C and DPP® Influenza tests.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $7 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 known as Inverness Medical Innovations, Inc. Chembio markets its HIV STAT-PAK(R) 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(R)) technology, which has significant advantages over lateral-flow technologies in numerous applications. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP(R). 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, and actual results 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.

Contacts:

Company Contact

Susan Norcott

631-924-1135 x125

snorcott@chembio.com

Investor & Public Relations

The Investor Relations Group

212-825-3210

James Carbonara

JCarbonara@investorrelationsgroup.com