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):  November 3, 2011 (November 3, 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 November 3, 2011, the Company issued a press release entitled “ChembioReports 3rd Quarter 2011 Results”.   A copy of the press release is furnished herewith as Exhibit 99.1.

On November 3, 2011 the Company posted a PowerPoint Presentation to their website entitled “Investor Presentation November 2011.”  A copy of the presentation is furnished herewith as Exhibit 99.2.

In addition, also on November 3, 2011, the Company posted an Investor Fact Sheet to their website.  A copy of the fact sheet 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 Reports 3rd Quarter 2011 Results” dated November 3, 2011.
99.2	Presentation entitled “Investor Presentation November 2011” dated November 3, 2011.
99.3	Investor Fact Sheet posted to the company website dated November 3, 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.

November 3, 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 Reports 3rd Quarter 2011 Results” dated November 3, 2011.
99.2	Presentation entitled “Investor Presentation November 2011” dated November 3, 2011.
99.3	Investor Fact Sheet posted to the company website dated November 3, 2011.

EX-99.1

Chembio to Host Conference Call to Discuss 3rd Quarter 2011 Financial Results

Conference Call Scheduled for Thursday, November 3rd

At 10:00 a.m. Eastern Time

MEDFORD, NY, November 2, 2011 -- Chembio Diagnostics, Inc. (OTC/QB: CEMI & OTC/PK: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, announced today that the Company will release financial results for the third quarter of 2011, before the open of the market on Thursday, November 3, 2011. The Company’s 10-Q and earnings press release will be available immediately after 9:15 a.m. on our web site.

Lawrence A. Siebert, Chembio's president and chief executive officer, will host an investment community conference call beginning at 10:00a.m. Eastern Time on Thursday, November 3, 2011, to discuss these results and to answer questions. He will be joined by Richard Larkin, Chembio's chief financial officer.

To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until November 10, 2011 at 11:59 p.m. Eastern Time by dialing (877) 660-6853 from the U.S. or (201) 612-7415 from outside the U.S. and entering reservation account number 286 and conference ID #: 381588. The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=166292.  An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com.

Those interested in listening to the conference call live via the Internet may do so by visiting the Investor Relations section of Chembio's website at www.chembio.com. To listen to the live call, please go to the website 15 minutes prior to its start to register, download, and install the necessary audio software. A replay will be available on the website for a limited time.

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 North America, 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 130 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. Theyreflect 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:

Company: Susan Norcott

(631) 924-1135 Ext. 125

snorcott@chembio.com

Investor Relations:

The Investor Relations Group:

Adam Holdsworth

212-825-3210

aholdsworth@investorrelationsgroup.com

EX-99.2

Chembio Reports 3rd Quarter 2011 Results

Conference Call Scheduled for Thursday, November 3, 2011,

 at 10:00 a.m. Eastern Time

MEDFORD, N.Y (November 3, 2011) – Chembio Diagnostics, Inc. (OTC.PK: CEMI and OTC.QB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, reported revenues and earnings for the quarter ended September 30, 2011. Total revenues were $5.92million for the quarter ended September 30, 2011, a quarterly record for the Company, which compares to total revenues of $4.51 million for the quarter ended September 30, 2010, a 31.5% increase.  The Company recorded net income of approximately $.48 million for the quarter ended September 30, 2011, compared to net income of approximately $.17 million for the quarter ended September 30, 2010, an increase of 183%.   Basic earnings per share, after rounding, were approximately $.01 per share for the quarter ended September 30, 2011, as compared with less than $0.01 per share for the year earlier period.

For the nine months ended September 30, 2011, total revenues were $13.17 million which compares to total revenues of $11.04 million for the nine months ended September 30, 2010, a 19% increase.  The Company recorded net income of approximately $.53 million for the nine months ended September 30, 2011, compared to net income of approximately $.63 million for the nine months ended September 30, 2010, a decrease of 16.5%.  Basic earnings per share, after rounding, were approximately $.01 per share for each of the of the nine-month periods.

The Company had a 46% increase in Net Product Sales during the third quarter as compared with the comparable period in 2010.  This resulted from a $.82 million or 75% increase in sales to Alere, Inc. of our FDA-approved rapid HIV tests for marketing in the U.S. to $1.91 million and a $1.70 million increase in sales of our DPP® products, all to the Oswaldo Cruz Foundation (“FIOCRUZ”) in Brazil, to $1.705 million. The approximate $1.74 million increase in Net Product Sales for the third quarter was partially offset by a decrease of $287,000 in R&D, milestone and grant revenue and a decrease of $37,000 in license and royalty revenue.  The increased sales to Alere and Brazil together with increased sales to Mexico and Asia, substantially outpaced a decrease in sales to Africa and combined to produce a 52.7% increase in product gross margin dollars as compared to the third quarter of 2010. The product gross margin increased by almost two percentage points, from 39.4% in the third quarter of 2010 to 41.2% in the third quarter of 2011.  Overall gross margin was 45% for the three months ended September 30, 2011.

The Company had a record gross margin for the quarter ended September 30, 2011 of $2.67 million as compared to $2.20 million in the quarter ended September 30, 2010.  Gross margin for the nine months ended September 30, 2011 was $6.65 million as compared to $5.61 million in the nine months ended September 30, 2010. These product sales, together with increased gross margins have enabled the Company to increase funding of research, development, clinical and regulatory programs by approximately $.88 million in 2011 while still maintaining a net income.

For the nine months ended September 30, 2011, the Company had a 38% increase in Net Product Sales consisting of a 52% increase in sales to Alere, Inc. of our FDA-approved rapid HIV tests for marketing in the U.S. and a $2.60 million increase in sales of our DPP® products to Brazil.  The 2010 DPP® net product sales were only $6,500.   These increases, together with overall sales increases and changes in product mix, combined to produce a 71.6% increase in product gross margin dollars as compared to the first nine months of 2010. The product gross margin increased by 8.5 percentage points, from 34.9% in the first nine months of 2010 to 43.4% in the first nine months of 2011.  Overall gross margin was 50.5% for the nine months ended September 30, 2011.

The Company’s cash increased for the nine months ended September 30, 2011 by $909,000, to $3.05 million, as compared to an increase in cash for the same period in 2010 of $268,000.  The increases during the 2011 and 2010 periods are primarily attributable to cash provided by operations. The increase in the 2011 period also includes cash received from the change in receivables of $1.29 million, an increase in deferred revenue of $426,000, an increase of $286,000 in loans from HSBC on the revolver for equipment purchases and a $290,000 increase in accounts payable and accrued liabilities.  These cash increases for the nine-month period were partially offset by an increase in inventories of $1.24 million. In addition the Company received $205,000 from the exercise of warrants.  The increased cash from operations in 2011 was also attributable to non-cash expenses aggregating $458,000, primarily from depreciation and amortization expense.

Lawrence Siebert, Chembio’s Chief Executive Officer, commented, “Chembio had a very strong quarter as we manufactured a record volume of products, improved product gross margins, maintained our commitment to investing in our product pipeline, and generated strong bottom line results and cash flow.”

Financial Highlights for the Quarter ended September 30, 2011

·   Product sales for the quarter ended September 30, 2011 (third quarter) increased 46% to $5.53 million from $3.79 million in the same period of 2010.

·   R&D, milestone and grant revenues for the third quarter decreased to $.37 million from $.66 million in the same period of 2010, and license and royalty revenue decreased to $.03 million from $.06 million.

·   The increased product revenue, together with changes in product mix, partially offset by decreased R&D and licensing and royalty revenues, combined to produce gross margin dollars that were $.46 million, or 21%, higher ($2.67 million vs. $2.21 million) than the gross margin dollars in the comparable period in 2010.  Product gross margin increased by $.79 million, or 52.7% ($2.28 million vs. $1.49 million), over the comparable period in 2010.

·   Research and development expenses remained nearly constant compared to the 2010 period.  The mix of items did change, for instance an increase in clinical trials of $61,000 was partially offset by a decrease in materials of $58,000.

·   Selling General & Administrative Expenses increased in the third quarter of 2011 by $147,000 over the comparable third quarter of 2010.  An increase in commissions, due to the higher DPP product sales to Brazil, as well as increases in wages, share-based compensation and other expenses, partially offset by decreased professional fees was responsible for the increase.

·   Operating income was approximately $.48 million in the third quarter of 2011 as compared to operating income in the third quarter of 2010 of approximately $.18 million. In addition, net income was approximately $.48 million in the third quarter of 2011 as compared to a net income in the third quarter of 2010 of approximately $.17 million.

Financial Highlights for the nine months ended September 30, 2011

·   Product sales for the nine months ended September 30, 2011 increased 38% to $11.52 million from $8.34 million in the same period of 2010.

·   R&D, milestone and grant revenues for the nine months decreased to $1.53 million from $2.30 million in the same period of 2010, and license and royalty revenue decreased to $.13 million from $.40 million.

·   The increased product revenue, together with changes in product mix, partially offset by decreased R&D and licensing and royalty revenues, combined to produce gross margin dollars that were $1.04 million, or 18.5%, greater ($6.65 million vs. $5.61 million) than the gross margin dollars in the comparable period in 2010.  Product gross margin increased by $2.08 million, or 71.6% ($4.99 million vs. $2.91 million), as compared with the comparable period in 2010.

·   Research and development expenses increased by $.87 million, or 31%, to $3.70 million compared to $2.82 million in the 2010 period.  The increase is primarily due to an increase of $.66 million in clinical trial expenses.

·   Selling General & Administrative Expenses increased by $.27 million or 12.6% in the first nine months of 2011 as compared to the first nine months of 2010.  This was primarily due to an increase in commissions for the shipment of our DPP® products to Brazil.

·   Operating income was approximately $.54 million in the first nine months of 2011 as compared to operating income in the first nine months of 2010 of $.64 million. In addition, net income was approximately $.53 million in the first nine months of 2011 as compared to net income in the first nine months of 2010 of $.63 million.

·   The September 30, 2011 cash balance was $3.05 million as compared with $2.14 million at  December 31,  2010.  The increase in the 2011 period includes cash received from the change in receivables of $1.29 million, an increase in deferred revenue of $426,000, an increase of $289,000 in loans from HSBC on the revolver for equipment purchases and a $290,000 increase in accounts payable partially offset by an increase in inventories of $1.24 million.  In addition the Company received $205,000 from the exercise of warrants.  The increased cash from operations in 2011 was also attributable to non-cash expenses aggregating $458,000, primarily from depreciation and amortization expense.

***********************

Summary of Clinical, Development and Regulatory Activities

CLINICAL & REGULATORY

CE Mark for FDA approved HIV tests – The final studies for the CE Marking requirements are complete and we submitted this data during October 2011.

Regulatory Approvals in Brazil through the Oswaldo Cruz Foundation (FIOCRUZ) – During 2010 we received notification from FIOCRUZ that our DPPâ HIV 1/2 screening test and our DPPâ HIV confirmatory test were each approved by Brazil's National Health Surveillance Agency (ANVISA).  During 2011 our DPP® visceral canine leishmania ("VL") rapid test was approved by Brazil’s Ministry of Agriculture, Livestock and Food Supply ("MAPA"). This is the first diagnostic product that FIOCRUZ has successfully submitted for approval to MAPA.  In addition, FIOCRUZ received the required approval from ANVISA for the DPP® Syphilis-Treponemal test and the DPP®-Leptospirosis test.  The submission for the DPP® multiplex Syphilis Treponemal-Non-Treponemal has not yet occurred.

FDA Approval for DPP® HIV 1/2 Screening Assay – We began submitting the PMA (Pre-Marketing Approval) application using the Modular PMA option, and we have thus far submitted Module I containing manufacturing information and Module II containing non-clinical data, which was submitted in the beginning of October 2011.  We have experienced some delays in completing the clinical trials, which are the main component for the final Module III.  We now expect to finish the clinical trials during the fourth quarter of 2011. As of October 31, 2011 we have completed approximately 90% of the 3,000-patient clinical trials. We believe that the results of the clinical trials thus far indicate that the sensitivity and specificity of this product on all matrices meets or exceeds the performance requirements for FDA approval. However the trials are not complete and there can be no assurance that the FDA will agree with our assessment.

DPP® Syphilis Screen & Confirm - We are engaged in a number of activities oriented to commercializing this product.  We have commenced testing at the first of three sites in support of our planned 510(K) clearance of this product.   During October 2011 we received CE Marking for this product and this is allowing us to start commercializing it outside the United States.

Sure Check HIV for Consumer Self-Testing –  In September 2011, the Company received clarification from the Food and Drug Administration for the regulatory requirements for the Sure Check® HIV 1/2 rapid test for sale over-the-counter (OTC).  Additional studies are required for submission of an Investigational Device Exemption (IDE) as the first step toward product approval.  We believe these studies can be completed by the end of the first quarter of 2012 at which time we would submit our IDE to the FDA.

RESEARCH & DEVELOPMENT

DPP® Leptospirosis – We have approximately nine months left of the three-year $3 million Small Business Innovative Research (SBIR) Phase II grant we were awarded in 2009 by the United States National Institutes of Health (NIH) to fully develop, validate, and commercialize a rapid diagnostic test for Leptospirosis for general use worldwide.  Our work pursuant to this grant is progressing on schedule. The test will be developed with our DPP® technology and will utilize proprietary reagents developed by Yale University and the Oswaldo Cruz Foundation at the Brazilian Ministry of Health.  Development of the test will be in collaboration with the Division of Infectious Diseases, Yale University in New Haven, CT and the Oswaldo Cruz Foundation, the largest biomedical research institution in Latin America.

DPP® Tuberculosis – As reported in February 2011, we were awarded a three-year $2.9 million, subsequently reduced to $2.4 million, Small Business Innovative Research (SBIR) Phase II grant from the United States National Institutes of Health (NIH) to continue development of a simple, rapid, accurate, and cost-effective serological test for active tuberculosis that can be utilized in resource-limited settings.

Battelle/CDC DPP® Influenza Immunity Test–Our prototypes were evaluated by Battelle/CDC and this resulted in a request for additional development work during the summer.  Subsequently, in October 2011, we recently entered into an amendment of this contract, beginning November 1, 2011, to continue additional development work for this product in the fourth quarter of 2011 and the first quarter of 2012.  This development work will be funded by approximately $250,000 in periodic milestone payments to be received by the Company during this period upon attainment of such milestones.

Other Research & Development Activities – We are considering certain new DPP® product opportunities, either as OEM development projects and/or as Chembio-branded products.  These products are being identified based upon our assessment of unique opportunities in the market and how they can be uniquely addressed by our proprietary technology, as well as by our development and manufacturing experience. We are also identifying and assessing additional technologies that we believe could provide us with additional products, and capabilities, and thereby provide additional revenue streams. Chembio continues to work with commercial, governmental and private organizations in order to obtain R&D contracts and grant funding for development projects.  These programs have subsidized the Company’s development expenses while expanding the applications for and know-how related to DPP®, and have also served in creating important collaborative relationships.

Conference Call

Chembio has scheduled a conference call and webcast for 10:00 a.m. Eastern time on Thursday, November 3, 2011.  To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until November 10, 2011 at 11:59 p.m. Eastern Time by dialing (877) 660-6853 from the U.S. or (201) 612-7415 from outside the U.S. and entering reservation account number 286 and conference ID #: 381588.  The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=166292.  An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com.

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 North America, 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 130 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. 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:

Company Contact:

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

Investor & Public Relations

The Investor Relations Group

212-825-3210

Adam S. Holdsworth aholdsworth@investorrelationsgroup.com

(Tables to follow)

Chembio Diagnostics, Inc.
Summary of Results of Operations
(Unaudited)
	For the three months ended				For the nine months ended
	September 30, 2011		September 30, 2010		September 30, 2011		September 30, 2010
Net product sales	$	5,526,883	$	3,786,572	$	11,516,325	$	8,337,133
License and royalty revenue		25,000		61,789		125,322		400,758
R&D, milestone and grant revenue		369,904		656,642		1,529,972		2,299,970
TOTAL REVENUES	$	5,921,787	$	4,505,003	$	13,171,619	$	11,037,861
GROSS MARGIN	$	2,670,733	$	2,208,501	$	6,647,353	$	5,609,841
Research and development expenses	$	1,242,295	$	1,230,100	$	3,697,309	$	2,822,455
Selling, general and administrative expenses	$	949,237	$	801,854	$	2,412,867	$	2,143,715
NET INCOME FROM OPERATIONS	$	479,201	$	176,547	$	537,177	$	643,671
NET INCOME	$	475,605	$	167,976	$	528,147	$	632,568
Basic net income per share	$	0.01	$	0.00	$	0.01	$	0.01
Weighted average number of shares outstanding, basic		63,304,584		62,146,847		62,887,212		62,068,204

Chembio Diagnostics, Inc.
Summary of Balance Sheets
	September 30, 2011		Dec 31, 2010
	(Unaudited)
CURRENT ASSETS:
Cash and cash equivalents	$	3,045,348	$	2,136,351
Accounts receivable, net of allowance for doubtful accounts of $20,000 and $35,000 for 2011 and 2010, respectively		2,657,781		3,946,398
Inventories		2,588,225		1,349,161
Prepaid expenses and other current assets		188,841		204,824
TOTAL CURRENT ASSETS		8,480,195		7,636,734
FIXED ASSETS, net of accumulated depreciation		848,799		813,214
OTHER ASSETS
Deposits on equipment		208,460		-
License agreements and other assets		561,226		636,226
	$	10,098,680	$	9,086,174
TOTAL CURRENT LIABILITIES	$	3,199,016	$	3,076,457
TOTAL OTHER LIABILITIES		145,859		200,773
TOTAL LIABILITIES		3,344,875		3,277,230
TOTAL STOCKHOLDERS’ EQUITY		6,753,805		5,808,944
	$	10,098,680	$	9,086,174

Chembio Diagnostics, Inc.
Summary of Cash Flow
	For the nine months ended (Unaudited)
	September 30, 2011			September 30, 2010
Net cash provided by operating activities	$	1,559,123		$	213,731
Net cash used in investing activities		(282,175	)		(188,193	)
Net cash (used in) provided by financing activities		(367,951	)		242,210
INCREASE IN CASH AND CASH EQUIVALENTS	$	908,997		$	267,748

#   #   #

EX-99.3

RAPID Tests for EARLIER Treatment

Investor Presentation

Slide 2

Forward Looking Statements

Statements contained herein that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended.  Those statements include statements regarding the intent, belief or current expectations of Chembio and its management. 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 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

Slide 3

Chembio Overview

•   Develops, Manufactures and Markets Rapid Point of Care Test (POCT) Products

•   Current POCTs for HIV, Syphilis & Other Infectious Diseases, applicable to many other markets

•   Base Business Utilizes In-Licensed Lateral Flow Technology

•   New Business Based on Chembio’s Dual Path Platform (DPP®)

•   Branded & Private Label (OEM) Strategy

•   Five DPP® POCTS Approved in Brazil 2010-11 Now  Being Launched by Brazilian Ministry of Health through its affiliate Oswaldo Cruz Foundation, Chembio’s OEM customer.

•   FDA & USDA Approved Leased Manufacturing Facility in Medford, NY

•   140 Employees

Slide 4

Financial Overview

·   Five Year Compounded Annual Revenue Growth of 33%

·   Gross Margin Expansion

o   Higher ASP’s in US

o   Scale up Efficiencies

·   Increased investment in R&D pipeline

o   DPP HIV Clinical Trials

      -   2007 Recapitalization

(See graph)

Slide 5

POCT’s – A Growing Global Market

•   $7B Global Point-of-Care Test (POCT) Market

•   Fastest Growing Segment of $39.5B In-Vitro Diagnostics Market

•   POCTs for HIV, Syphilis Serve Crucial Public Health Objectives

o   Professional US Rapid HIV Test Market Now ~7 Million tests annually

§   OTC Market Opportunity for Sure Check® HIV test being pursued

o   Chembio’s Unique Dual Band DPP® Syphilis Screen & Confirm, CE Marked October 2011

Slide 6

DUAL PATH PLATFORM (DPP®)

Chembio’s Proprietary POCT Technology

•   Independent Sample Flow Path Enables Improved Sensitivity & Use of More Challenging Sample Types

•   Improved Multiplexing Facilitated by Direct Binding, Uniform Delivery of Samples

•   Visual and/or Instrument Read-Out

•   Patents issued in several global markets including U.S., UK, Australia, Eurasia and China

o   Additional DPP® Patents Pending in the U.S. and many foreign countries

(see graphics)

Slide 7

Chembio-Branded Products Complemented by Current & Future OEM Programs

Current OEM/Licensees:  Fiocruz (Brazil), BIORAD, Alere

Potential Future OEM/License Areas: Infectious Diseases, Veterinary Wellness

DPP® HIV SCREENING TEST – DPP® SYPHILIS SCREEN & CONFIRM – SURE CHECK® HIV OTC – SINGLE PARAMETER & MULTIPLEX INFECTIOUS DISEASE PRODUCTS

Slide 8

Lateral Flow Rapid HIV Tests

·   25% of 1.1MM HIV+ Individuals in U.S. Not Aware of their Status

·   Products Sold in US Professional Market by Alere Inc. (NYSE:ALR) as Clearview® brand

o   10-Year Exclusive Agreement through Sept. 2016 based on ASP sharing

o   9 Month Sales $5.39 Million, a 52% increase YTD v. comparable 2010 period

·   Ex-US Under Chembio Brands (STAT PAK® & SURE CHECK®)

Slide 9

U.S. Rapid HIV Test Market

	Clearview Complete	Clearview STAT PAK®	DPP® HIV Screen	OraQuick	Uni-Gold
	(See Graphic)	(See Graphic)	(See Graphic)	(See Graphic)	(See Graphic)
Manufacturer	Chembio	Chembio	Chembio	Orasure Technologies, Bethlehem PA	Trinity Biotech, Dublin Ireland
Current or Planned Distribution	Private Label for Alere Direct & Distribution	Private Label for Alere Direct & Distribution	Direct & Distributors	Direct sales force	Direct sales force & distributors
FDA Approval Date	2006	2006	Clinical trials	2003	2003
Technology	Lateral Flow	Lateral Flow	Dual Path Platform (DPP®)	Lateral Flow	Lateral Flow
Est. US Market Shr.	8%	12%	N/A	65%	15%
FDA Sensitivity	99.7%	99.7%	TBD	99.3%OF/99.6% WB	100%
FDA Specificity	99.9%	99.9%	TBD	99.8%OF/100% WB	99.7%
Features
Sample Types	All Blood Matrices	All Blood Matrices	Blood & Oral Fluid Claims being pursued	Oral Fluid and all blood matrices except serum	All Blood Matrices
True IgG Control	Y	Y	Y	Y	N
Sample Size (in microliters)	<5	<5	<5	<5	40
HIV-2	Y	Y		Y	N

Slide 10

Pipeline: Chembio-Branded Products Anticipated Timelines – US Market

CLINICAL TRIALS/REGULATORY SUBMISSIONS

REGULATORY APPROVAL OR CLEARANCE/COMMERCIAL SALES

Product	2011	2012	Est. Current & Potential U.S. Market Size
DPP® HIV Screen	Anticipated Completing Clinical Trials December; PMA Module I Submitted and responded. PMA Module II submitted in October	Respond to Module II & Submit Module III Q1. FDA Approval,  CLIA waiver, US Market Launch	$70MM/$150MM US POCT Market Developed into 7MM Unit Market since 2003
DPP® Syphilis Screen & Confirm	CE Marking Granted October; Establishing EU Distribution;  Clinical Trials Commenced for US FDA 510(K) Submission	Launch in EU ; Complete clinical trials in US & Submit 510(K) to FDA for Clearance and US Launch	NA/$50MM 69MM Syphilis tests performed in US; 50MM Clinical; Assumes 20% convert to POCT
Sure Check® HIV OTC	Product Already Approved for Professional Use which is pre-requisite; Submitting IDE for Self Testing Protocol	Complete Pre-ID Requirements and Begin Phase II Clinical Trials	NA/$150MM Assumes $30 OTC Test

Slide 11

Pipeline: OEM Contracts with FIOCRUZ Brazil

Anticipate Minimum of $3MM in 2011 Revenues v. $.6MM in 2010

Contract	2010	2011	2012
DPP® HIV Screening	Approved, Commercial Sales	Commercial Sales	Commercial Sales
DPP® HIV Confirmatory	Approved	Commercial Sales	Commercial Sales
DPP® Syphilis Treponemal	Agreement Signed December 2010	Approved Q1 ‘11, Commercial Sales	Commercial Sales
DPP® Syphilis Treponemal/ Non-Treponemal		Submission, Approval	Commercial Sales
DPP® Canine Leishmaniasis	Submitted	Approved Q1’11, Commercial Sales	Commercial Sales
DPP® Leptospirosis		Approved Q3’11	Commercial Sales

Slide 12

Pipeline: Other Products

Project	Activity
Multiplex DPP® Product Developed for & Licensed to Bio-Rad Laboratories, Inc.	Development completed. Anticipate CE Mark EOY 2011 – Launch EU Fall 2012.  Manufacturing by Bio-Rad. Royalties to Chembio upon Commercial Sales
Multiplex  DPP® Influenza Immune Status Product Developed for Battelle/CDC	Prototype Development Completed; Prototype products being evaluated at CDC. Additional development work Q4 2011 – Q1 2012.
New DPP® OEM Applications	Veterinary
Potential New DPP® Branded Products	Infectious Diseases, Women’s Health, Cervid Veterinary TB
DPP® Platform Enhancements	Buffer Integration and “DUAL DPP®” projects in progress
NIH Phase II Grant – Leptospirosis & Tuberculosis	DPP® Leptospirosis - $2.9MM 3 Year Grant awarded 6/2009.  Prototype Developed.  Further reagent discovery underway.  Approximately $1MM funding remaining as of 10/1/2011.  Chembio is principal grantee. DPP® Tuberculosis - $2.4MM, 3 Year Grant awarded Effective 3/1/2011.  Prototype Developed. Planning Multi-site Evaluations and Optimization, Validation and Commercialization.  Chembio is principal grantee.

Slide 13

Financial Summary

FY 2008-2010 Results

•   Record Revenues and Earnings

•   Improving Gross Margins

•   Controlled Operating Expenses

•   Operating Cash Flow Strengthened Balance Sheet

(See Graphic)

Slide 14

2010 Full Year and 9 Month 2010 & 2011 Selected Financial Results

	September 30, 2011-YTD		September 30, 2010- YTD		December 31, 2010
Net Product Revenues	$11,516,325		$8,337,133		$13,516,359
Non- Product Revenues	1,655,294		2,700,728		3,188,344
TOTAL REVENUES	13,171,619		11,037,861		16,704,703
GROSS MARGIN	6,647,353	50%	5,609,841	51%	8,100,699	48%
OPERATING COSTS:
Research & Development Costs	3,697,309	28%	2,822,455	26%	2,586,308	15%
Selling, general and administrative expense	2,412,867	18%	2,143,715	19%	2,940,721	18%
	6,110,176		4,966,170		5,527,029
INCOME FROM OPERATIONS	537,177		643,671		2,573,670
OTHER INCOME (EXPENSES):	(9,030)		(11,103)		(60,326)
NET INCOME	528,147	4%	632,568	6%	2,513,344	15%

(See Graphic)

Slide 15

Three Months September 2010 & 2011 Selected Financial Results

	3 Mos. September 30, 2011		3 Mos. September 30, 2010
Net Product Revenues	$5,526,883		$3,786,572
Non-Product Revenues	394,904		718,431
TOTAL REVENUES	5,921,787		4,505,003
GROSS MARGIN	2,670,733	45%	2,208,501	49%
OPERATING COSTS:
Research and development expenses	1,242,295	21%	1,230,100	27%
Selling, general and adminstrative expense	949,237	16%	801,854	18%
	2,191,532		2,031,954
INCOME FROM OPERATIONS	479,201		176,547
OTHER INCOME (EXPENSES):	(3,596)		(8,571)
NET INCOME	475,605	8%	167,976	4%

(See Graphic)

Slide 16

Revenue Growth by Category: 2009 vs. 2010

(see graphic)

Slide 17

Revenue Growth by Category: Q3’11 YTD vs. Q3’10 YTD

(see graphic)

Slide 18

Selected Balance Sheet Data

($ in millions)	Sept’11	Dec. '10	Dec. '09
Cash	$3,045	2,136	1,068
Accounts Receivable	2,658	3,946	1,776
Inventories	2,588	1,349	1,556
Total Current Assets	8,840	205	4,667
Net Fixed Assets	849	813	580
Other Assets	770	636	1,068
Total Assets	$10,099	9,086	6,315
Total Current Liabilities	3,199	3,076	3,173
Total Liabilities	3,345	3,277	3,227
Total Equity	6,754	5,809	3,088
Total Liabilities & Shareholders Equity	$10,099	9,086	6,315

Slide 19

Anticipated Milestones 2012

Clinical & Regulatory Programs for Branded Products

•   Submit Module III for DPP®HIV PMA, Receive FDA PMA Approval and CLIA waiver

•   Complete Syphilis Screen & Confirm Clinical Trials, Submit to FDA for 510(K) Clearance, Receive Clearance

•   Complete Sure Check HIV OTC Pre-IDE, Commence Phase II Clinical Trials

•   New Claims for Veterinary TB

Product Revenues & Operating Results

•   Full Year of New Products launched in Brazil through FIOCRUZ

•   Launch of DPP® Syphilis Screen & Confirm in Europe

•   Continued US Lateral Flow HIV Test Market Share Gains

•   Potential New International Market Opportunities for Lateral Flow and DPP® Products

Research & Development

•   New Branded Products to Replenish Pipeline

•   New OEM Development Agreements

Slide 20

Leadership

Executive	Joined Company*
Lawrence Siebert,  Chairman & CEO	2002
Richard Larkin, CFO	2003
Javan Esfandiari, SVP R&D	2000
Tom Ippolito, VP Regulatory, Clinical, QA/QC	2005
Rick Bruce, VP Operations	2000
Independent Directors	Joined Board
Gary Meller, MD, MBA	2005
Kathy Davis, MBA	2007
Barbara DeBuono, MD MPH	2011
Peter Kissinger, Ph.D	2011

Slide 21

TOTAL EMPLOYMENT Approx. 140

Research and Development – 12

Regulatory and Clinical QA & QC – 13

Sales, General & Administration – 9

Operations- 106

Fully Integrated FDA & USDA Approved Development & Manufacturing in 24,000 S/F Leased Facility in Medford, NY

Slide 22

Potential Impact of OEM & Branded Products on Revenue*

(See Graphic)

Slide 23

CEMI Selected Share Data

Ticker Symbol (OTC:QB)	CEMI.QB
Price 10/31/2011	$ .450
52-Week High	$0.580
52-Week Low	$0.210
Outstanding Shares	63.3
Market Capitalization	$0.00
Fully Diluted Shares	69.6
Management Holding	12.4
Average Daily Volume (3 months)	50,000

Options and Warrants	Amt.	Avg. Ex. Price
Options (4.64MM held by mgmt. & board)	6.09	$0.213
Warrants (MM)-Exp. By 02/15/12	.07	$0.810
Total Options & Warrants (MM)	6.26	$0.22

(See graphics)

Slide 24

DPP® HIV Screening Assay For Use with Oral Fluid or Blood Samples

·   Submitted PMA Module I in Q2 2011

·   Submitted PMA Module II in October 2011 US

·   Clinical trials being completed Q-4 2011 for Submission of Module III  Q1 2012

·   Anticipated FDA OMA Approval, CLIA waiver and Product Launch in 2012

 (See graphic)

Slide 25

DPP® Syphilis Screen & Confirm

•   First POCT in US for Syphilis

•   All Pregnant Women Tested for Syphilis

•   Current Laboratory Tests Inadequate

•   Enables Confirmation & Treatment At POC

•   International Evaluation Ongoing in China

•   Anticipate FDA Clearance in early 2012

(See graphic)

Slide 26

SURE CHECK® HIV OTC

Pre- IDE Studies 2011, Q1-2012 with “Phase II” Clinical Trials Beginning Thereafter

•   Patented All-In-One Barrel Device

•   Increasing Market Acceptance in Professional Market (Clearview by Alere)

•   IDE, Clinical Trials 2012-2013

•   Anticipated Approval 2014

(See graphic)

Slide 27 

(See graphics)

EX-99.4

PAGE 1

Investor Fact Sheet

Ticker Symbol: CEMI

www.chembio.com

Business Summary & Investment Highlights

Chembio Diagnostics, Inc., (Chembio), through its wholly owned subsidiary Chembio Diagnostic Systems, Inc. develops, manufactures, licenses and markets point-of-care testing (POCT) products. Chembio created and patented a new revolutionary technology called Dual Path Platform (DPP®). The technology is addressing critical market requirements in the infectious diseases testing market and other growing markets. Products under development, both OEM and branded, are anticipated to create significant new revenue streams that will add to Chembio’s core business of rapid HIV tests.

·   >33% Five Year Revenue CAGR during which operating performance improved continuously

·   Consecutive record revenues and profits in 2009 and 2010.

·   Strategy is to create core business of public health and women’s health products to be complemented by OEM and selected out-licensing opportunities. Robust pipeline of POCT products for infectious diseases based on Chembio’s patented DPP® technology. Products developed on DPP® platform for two HIV and Syphilis tests that will be undergoing US FDA regulatory evaluations/submissions in 2011-2012.

·   Significant income from research contracts and grants, including $2.4MM, three year Phase ll United States National Institutes of Health grant awarded in March, 2011 and a similar $3MM grant awarded 2009 (to be completed 2011)

Selected Financial Information

Stock Information

Ticker Symbol CEMI

Price 10/31/11 $0.450

52 Week High $0.58

52 Week Low $0.210

Outstanding Shares (MM) 63.3

Market Capitalization (MM) $28.5

Fully Diluted (FD) Shares 69.6

Management Holding-FD 12.4

Average Volume (3 Mos) 50,000

Major Beneficial Holders Beneficial Shares Owned (MM)

Lawrence Siebert 7.1

Alere North America, Inc. 5.4

($000s)
Balance Sheet Data	Sept ‘11	Dec'10
Cash	$ 3,045	$   2,136
Accts. Receivable	2,658	3,947
Inventories	2,588	1,349
Other Current Assets	189	205
Total Current Assets	8,480	7,637
Net Fixed Assets	849	813
Other Assets	770	636
Total Assets	10,099	9,086
Total Current Liab.	3,199	3,076
Total Other Liab.	146	201
Total Liabilities	3,345	3,277
Total Equity	6,754	5,809
Total Liabilities & Shareholders Equity	10,099	$    9,086

	For the Quarter Ended/                             Nine Months Ended/                            Year Ended
$(000s)	Q3’11	Q3’10	Q3’11	Q3’10	2010	2009	2008	2007
Total Revenues	$5,922	$4,505	$13,172	$11,038	$ 16,705	$13,834	$11,050	$ 9,231
Cost of sales	3,251	2,296	6,525	5,428	8,604	7,974	7,198	6,435
Gross Profit	2,671	2,209	6,647	5,610	8,101	5,860	3,852	2,796
					48.5	42.4%	34.9%	30.3%
R&D Expense	1,242	1,230	3,697	2,822	2,586	2,884	2,605	1,907
SG&A Expense	949	802	2,413	2,144	2,941	2,659	3,317	3,765
Operating Income (Loss)	480	177	537	644	2,574	317	(2,071)	(2,876)
Other Inc. (Expense)	(4)	(9)	(9)	(11)	(15)	(8)	122	249
Net Income (Loss) - Stkhldrs	476	168	528	633	2,559	309	(1,949)	(2,627)
Pref. Stock Expenses	-	-	-	-	-	-	-	5,645
Net Loss	$476	$168	$ 528	$ 633	$   2,513	$    309	$  (1,949)	$(8,272)
Net Income (Loss) - per Share	0.01	0.00	0.01	0.01	$    0.04	$   0.00	$    (0.03)	$    (0.57)
Avg. No. Shares (Millions)	63.305	62.147	62.887	62.06	62.103	61.946	61.267	14.608
Working capital	$ 5,281	$ 2,592	$  5,281	$ 2,592	$  4,560	$ 1,494	$ 1,664	$   3,229
Total assets	10,099	7,563	$10,099	7,563	9,086	6,315	5,915	6,585
Total liabilities	3,345	3,674	3,345	3,674	3,277	3,227	3,338	2,322
Equity (Deficit)	6,754	3,889	6,754	3,889	5,809	3,088	2,577	4,263

Chembio Diagnostics, Inc.	Investor Relations	Company Contact
3661 Horseblock Road	The Investor Relations Group Adam S. Holdsworth	Susan Norcott, Snorcott@chembio.com
Medford, NY 11763	aholdsworth@investorrelationsgroup.com	631-924-1135 x125
Ph. 631-924-1135	212-825-3210
Fax 631-924-2065
www.chembio.com

PAGE 2 – See Graphics

Chembio’s Lateral Flow Rapid HIV Tests Marketed Exclusively in the USA by Alere North America, Inc.

DPP® Technology

Competitive Advantages For POC Testing

• Improved Sensitivity - enabled by more efficient binding method

• Easier Multiplexing - due to even and direct distribution of sample to multiple test lines

• Enhanced Sample Control - as result of independent sample migration path

• Clearer Results - efficient binding allows for improved functionality of instruments for   reading and reporting of qualitative or quantitative results

Chembio’s Dual Path Platform (DPP®) Patented in 2007

Senior Management Team

Lawrence A. Siebert, Chairman & CEO, 25 years of management and financing experience

Richard J. Larkin, CFO, 25 years of operational and financial experience

Javan Esfandiari, SVP R&D, 15 years of experience in development of in-vitro point of care products

Board of Directors

Katherine Davis - Former Lieutenant Governor and numerous other leadership positions for the State of Indiana; former senior executive of Cummins, INC. (NYSE:CMI)

Dr. Gary Meller - Broad experience in medical and information technology and pharmaceutical product development

Dr. Barbara DeBuono – Former New York Commissioner of Health and Rhode Island Director of Health; other positions in domestic and international medical services

Dr. Peter Kissinger – Has founded and/or led 3 biotechnology and/or biomedical technology companies, including a publicly-traded NASDAQ company

Except for the historical information contained herein, the matters discussed in this document are forward-looking statements, the accuracy of which is subject to risks and uncertainties. Please refer to Chembio Diagnostic’s Inc. most recent Form 10-K and Forms 10-Q for additional information about the Company and related risks. –November 2011.