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):  May 5, 2011 (May 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 May 3, 2011, the Company issued a press release entitled “FIOCRUZ Receives Regulatory Approval to Market Chembio's Syphilis Treponemal Test”.   A copy of the press release is furnished herewith as Exhibit 99.1.

On May 5, 2011, the Company issued a press release entitled “ChembioReports 1st Quarter 2011 Results”.   A copy of the press release is furnished herewith as Exhibit 99.2.

On May 5, 2011, the Company posted a PowerPoint Presentation to their website entitled “Investor Presentation May 2011.”  A copy of the presentation is furnished herewith as Exhibit 99.3.

In addition, also on May 5, 2011, the Company posted an Investor Fact Sheet to their website.  A copy of the fact sheet is furnished herewith as Exhibit 99.4

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 “FIOCRUZ Receives Regulatory Approval to Market Chembio's Syphilis Treponemal Test” dated May 3, 2011.
99.2	Press Release entitled “Chembio Reports 1st Quarter 2011 Results” dated May 5, 2011.
99.3	Presentation entitled “Investor Presentation May 2011” dated May  5, 2011.
99.4	Investor Fact Sheet posted to the company website dated May 5, 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.

May  5, 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 “FIOCRUZ Receives Regulatory Approval to Market Chembio's Syphilis Treponemal Test” dated May 3, 2011.
99.2	Press Release entitled “Chembio Reports 1st Quarter 2011 Results” dated May 5, 2011.
99.3	Presentation entitled “Investor Presentation May 2011” dated May 5, 2011.
99.4	Investor Fact Sheet posted to the company website dated May 5, 2011.

EX-99.1

FIOCRUZ Receives Regulatory Approval to Market Chembio's Syphilis Treponemal Test

DPP® HIV 1/2 Confirmatory and Syphilis Tests Featured in Brazilian Symposium

MEDFORD, N.Y (May 3, 2011) – Chembio Diagnostics, Inc. (OTC/QB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, reported today that it has been notified that Bio-Manguinhos, a division of the Oswaldo Cruz Foundation of Brazil ("FIOCRUZ"), has received regulatory approval from Brazil's National Health Surveillance Agency ("ANVISA") to market Chembio's Dual Path Platform (DPP®) Syphilis Treponemal test, a point-of-care test for Syphilis.

This is one of two DPP® Syphilis tests that are covered by an agreement between FIOCRUZ and Chembio that was announced on November 30, 2010. The first DPP® Syphilis product now approved by ANVISA is a single parameter Treponemal test for the detection of antibodies specific to Syphilis. The second product, Chembio’s DPP® Syphilis Screen & Confirm Assay, is a multiplex test that incorporates the Treponemal as well as a Non-Treponemal parameter, thereby better enabling the detection and differentiation of active infections from past infections in one rapid, point-of-care device.  Currently two separate complex clinical laboratory tests must be performed in order to detect the presence of these two markers required to confirm an active syphilis infection. An evaluation of this multiplex product was commenced during the first quarter in China in collaboration with the WHO, and the Company is preparing for the initiation of U.S. clinical trials in support of a Section 510(k) pre-market notification for this product. The clinical trials are anticipated to begin next month.

Under the November 2010 agreement for the two Syphilis products, Chembio is committed to transfer technology to FIOCRUZ for these products in exchange for FIOCRUZ’s completion of specified minimum purchase commitments.  The technology transfer is anticipated to occur over a three-year period.  In order for Chembio to complete the transfer, the agreement requires purchases totaling at least $5.7 million by FIOCRUZ from Chembio, and an additional $1.8 million in additional components after the transfer is completed in the fourth and fifth years.

Syphilis remains a significant public health problem among pregnant women in Brazil, with a prevalence rate of 1.7%, and in many other countries, including the U.S. and China. Given the frequent asymptomatic nature of the infection and the importance of early treatment to prevent complications, antenatal screening has become the main focus for syphilis control in Brazil. Test results are available at the time of the initial patient visit, potentially avoiding a delay between the diagnosis and treatment and the associated risk of persistent infection.

This is now the fourth DPP® product approved in Brazil in less than one year, three by ANVISA and one, the DPP® Canine Visceral Leishmaniasis test, which approval was just announced in April, by Brazil’s Ministry of Agriculture, Livestock and Food Supply ("MAPA"). The DPP® Leptospirosis test is therefore now the only test under agreement with FIOCRUZ that is submitted and pending approval; Chembio and FIOCRUZ are working together to submit the multiplex Syphilis test to ANVISA for approval later this year.

The Company also reports that it has received confirmed orders from FIOCRUZ for each of the approved products and that it plans to provide investors an update of the anticipated 2011 shipments to FIOCRUZ.

This week FIOCRUZ is announcing the launch of the rapid HIV 1/2 confirmatory test that Chembio developed exclusively for FIOCRUZ, and which was approved by ANVISA in September, 2010, as well as the newly approved Syphilis test, at the 2nd International Symposium on Immuno-biology.  This symposium is coinciding with the 35th anniversary of Bio-Manguinhos, which is the FIOCRUZ division that Chembio works most directly with. Chembio’s Senior Vice President of Research & Development, Javan Esfandiari, has been invited to be one of the presenters at this symposium.  For more information on this event please go to http://www.simposiobio35.com.br/index.htmland http://www.simposiobio35.com.br/not03.html.

Lawrence Siebert, Chembio’s President and Chief Executive Officer, commented, “We are very pleased at the overall progress of our collaboration with FIOCRUZ, and the positive impact I believe it will have on our 2011 operating results.  I appreciate the work that our team has done to support FIOCRUZ’s efforts to obtain regulatory approval and support the strong demand for these products by the public health sector in Brazil.”

Conference Call Reminder

Chembio has scheduled a conference call and webcast for 10:00 a.m. Eastern time on Thursday, May 5, 2011 to discuss its first quarter results.  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 May 12, 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 #: 371515.  The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=164289.  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, 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 Reports 1st Quarter 2011 Results

Conference Call Scheduled for Thursday, May 5, 2011,

 at 10:00 a.m. Eastern Time

MEDFORD, N.Y (May 5, 2011) – Chembio Diagnostics, Inc. (OTC/QB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, reported revenues and earnings for the quarter ended March 31, 2011. Total revenues were $3.64million for the quarter ended March 31, 2011, which compares to total revenues of $2.78 million for the quarter ended March 31, 2010, a 30.6% increase.  The Company recorded a net loss of approximately $.14 million, or less than a $0.01 per share, for the quarter ended March 31, 2011, compared to a net loss of approximately $.15 million, or less than $0.01 per share, for the quarter ended March 31, 2010.

The 36% increase in Net Product Sales during the first quarter was as a result of a 77% increase in sales to Alere, Inc. of our FDA-approved rapid HIV tests for marketing in the U.S., continuing the pace of sales during the fourth quarter of 2010 and reflecting continued success of these products.   This increase, together with stable international product revenues, combined to produce a 77% increase in product gross margin dollars as compared to the first quarter of 2010. The product gross margin increased by 10 percentage points, from 33% in the first quarter of 2010 to 43% in the first quarter of 2011; overall gross margin was 53% for the three months ended March 31, 2011, a record for the Company.  The increased gross margin dollars, together with the previously reported 2010 results and cash flow (including but not limited to the $1.467MM of QTDP grants) have enabled the Company to accelerate the pace of the clinical trials for the DPP® oral fluid HIV test and other product development activities as are discussed below.

During the quarter the Company’s cash balance increased by over $.66 million, to approximately $2.80 million. The increase was primarily as a result of the collection of large account receivable balances as of December 31, 2010 from shipments made in December 2010, collection of the $.85 million balance due from the QTDP grant awards, and also as a result of approximately $.13 million of net non-cash expenses in the period, primarily depreciation and amortization. The cash balance increase is also after the Company paid in January the $.88 million balance due on its HIV-2 license from Bio-Rad Laboratories, Inc.

On April 26 the Company received approximately $.20 million from the exercise of approximately 500,000 warrants at $.40 per share, further strengthening the balance sheet.

Lawrence Siebert, Chembio’s Chief Executive Officer, commented, “We are quite pleased with the results of the first quarter, including the significantly increased gross margin dollars and increased net sales, which contributed to the increased cash balance despite the payment to Bio-Rad and the added clinical trial expenses. In addition we were further pleased by the exercise of warrants in April. During the quarter we achieved several other important objectives including another product approval by FIOCRUZ, the awarding of a Phase II NIH grant, and the filing of our first module in our PMA application with the FDA for our DPP® HIV screening assay.  In addition, as reported earlier this week, we have also now been informed that one of our two Syphilis tests contracted for with FIOCRUZ has been approved by ANVISA. We are now manufacturing for confirmed orders for all four of the products approved thus far and we look forward to providing an update of our anticipated shipments to FIOCRUZ. ”

Financial Highlights for the Quarter ended March 31, 2011

·   Product sales for the quarter ended March 31, 2011 (first quarter) increased 36% to $3.02 million from $2.21 million in the same period of 2010.

·   R&D, milestone and grant revenues for the first quarter increased marginally to $.59 million from $.55 million in the same period of 2010

·   The increased product and R&D revenues in the first quarter of 2011 combined to produce gross margin dollars that were $.62 million, or 47%, greater ($1.93 million vs. $1.31 million) than the gross margin dollars in the comparable period in 2010.  Product gross margin increased by $.57 million, or 77% ($1.31 million vs. $.74 million), over the comparable period in 2010.

·   Research and development expenses increased by $.49 million, or 61%, to $1.29 million compared to $.80 million in the 2010 period.

·   Selling General & Administrative Expenses increased by $.11 million or 17% in the first quarter of 2011 as compared to the first quarter of 2010.  This was primarily due to an increase in commissions for the milestone event achieved for our DPP® products.

·   Operating loss was approximately $.14 million in the first quarter of 2011 as compared to an operating loss in the first quarter of 2010 of $.16 million, a modest improvement. In addition, net loss was approximately $.14 million in the first quarter of 2011 as compared to a net loss in the first quarter of 2010 of $.16 million.

·   The March 31, 2011 cash balance was $2.80 million, $.66 million more than as of December 31, 2010.  This was primarily due to $2.23 million in cash provided from collections of accounts receivable.  Partially offsetting this cash inflow was a license payment of $.88 million.

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

Summary of Clinical, Development and Regulatory Activities

·   Regulatory Approvals in Brazil through the Oswaldo Cruz Foundation (FIOCRUZ) – During the first quarter, as recently reported, our DPP® visceral canine leishmania ("VL") rapid test was approved by Brazil’s Ministry of Agriculture, Livestock and Food Supply ("MAPA"). In April FIOCRUZ received approval from ANVISA for one of the two DPP® Syphilis tests we have under contract with them.  We believe FIOCRUZ will receive during 2011 the required approvals from ANVISA for the second DPP® Syphilis test and the DPP® Leptospirosis test, although there can be no assurance of this.    We are now manufacturing for confirmed orders for all four of the DPP® products now approved in Brazil and we look forward to providing an update on our anticipated shipments to FIOCRUZ.

·   FDA Approval for DPP® HIV 1/2 Screening Assay for Oral Fluid - We have collected over 2/3 of the clinical data required for submission to the FDA. As recently reported, we began submitting the PMA (Pre-Marketing Approval) application using the Modular PMA option, and we have thus far submitted the module containing the manufacturing information for this product.  We anticipate filing the remaining modules during 2011, although there can be no assurance of this.

·   DPP® Syphilis Screen & Confirm - We are engaged in a number of activities oriented to commercializing this product. We anticipate commencing clinical trials and other activities in support of a planned 510(K) clearance during the second quarter of 2011.

·   DPP® Influenza – We have made significant progress on our multiplex test for FLU A/B Antigen Detection and we are verifying the performance of our prototype in order to begin full validation and commencement of regulatory activities for this product.  Our current plan is still for product verification and validation to be completed during the second quarter of 2011 and for our clinical studies to be initiated during the balance of 2011.

·   DPP® Tuberculosis – As reported in February, we were awarded a three-year $2.9 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.

·   DPP® Hepatitis C and DPP® Hepatitis C/HIV Oral Fluid Antibody Tests – Various prototypes of these products are being developed and evaluated internally and externally, including a laboratory study that was organized by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) at the CDC, and field study that is commencing soon.  We have received the confidential results of the laboratory study which CDC is submitting for publication and we are continuing to pursue development activity.

·   CE Mark for FDA-approved HIV tests –The final studies for the CE Marking requirements are underway for our two FDA-approved rapid HIV tests, and the study is expected to be completed during the second quarter of 2011.  Submission of the final data will occur shortly thereafter.

There can be no assurance that any of these projects will continue, meet regulatory or other technical requirements and specifications, and/or that if continued, will result in completed products, or that such products, if successfully completed, will be successfully commercialized.

Conference Call

Chembio has scheduled a conference call and webcast for 10:00 a.m. Eastern time on Thursday, May 5, 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 May 12, 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 #: 371515.  The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=164289.  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. 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 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

(Tables to follow)

Chembio Diagnostics, Inc.
Summary of Results of Operations
	For the three months ended (Unaudited)
	March 31, 2011			March 31, 2010
Net product sales	$	3,015,063		$	2,214,897
License and royalty revenue		28,854			21,496
R&D, milestone and grant revenue		591,764			547,022
TOTAL REVENUES	$	3,635,681		$	2,783,415
GROSS MARGIN	$	1,926,342		$	1,306,374
Research and development expenses	$	1,290,142		$	800,758
Selling, general and administrative expenses	$	775,371		$	661,848
LOSS FROM OPERATIONS	$	(139,171	)	$	(156,232	)
NET LOSS	$	(142,297	)	$	(157,326	)
Basic and diluted loss per share	$	(0.00	)	$	(0.00	)
Weighted average number of shares outstanding, basic and diluted		62,284,772			61,986,165

Chembio Diagnostics, Inc.
Summary of Balance Sheets
	March 31, 2011		Dec 31, 2010
	(Unaudited)
CURRENT ASSETS:
Cash and cash equivalents	$	2,797,103	$	2,136,351
Accounts receivable, net of allowance for doubtful accounts of $20,000 and $35,000 for 2011 and 2010, respectively		1,726,517		3,946,398
Inventories		1,592,070		1,349,161
Prepaid expenses and other current assets		175,814		204,824
TOTAL CURRENT ASSETS		6,291,504		7,636,734
FIXED ASSETS, net of accumulated depreciation		772,290		813,214
OTHER ASSETS
License agreements and other assets		611,226		636,226
	$	7,675,020	$	9,086,174
TOTAL CURRENT LIABILITIES	$	1,759,620	$	3,076,457
TOTAL OTHER LIABILITIES		179,654		200,773
TOTAL LIABILITIES		1,939,274		3,277,230
TOTAL STOCKHOLDERS’ EQUITY		5,735,746		5,808,944
	$	7,675,020	$	9,086,174

Chembio Diagnostics, Inc.
Summary of Cash Flow
	For the three months ended (Unaudited)
	March 31, 2011			March 31, 2010
Net cash provided by (used in) operating activities	$	1,560,142		$	(192,074	)
Net cash used in investing activities		(46,358	)		(72,866	)
Net cash used in financing activities		(853,032	)		(5,372	)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	$	660,752		$	(270,312	)

#   #   #

EX-99.3

SEE PDF

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 Serving Global Markets

•   Diverse & Growing Pipeline of Proprietary Products

•   Fully Integrated FDA Approved Manufacturing Facility in NY

•   Record Financial Results  2009 & 2010

Slide 4

Financial Overview

·   Five Year Compounded Annual Revenue Growth of 33%

·   Simplified Capital Structure 12/2007

·   Retired ~$2MM debt Jan. 2009 – Jan. 2011

·   Record Revenues and Improved Operating Results Year after Year

·   Near and Long-Term Growth Catalysts

(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, HCV and other STDs Serve Crucial Public Health Objectives

•   Other Important POCT Markets

o   Infectious Diseases, Cardiac Markers, Companion Animal, OTC, Allergy

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

•   U.S. patents, and patents in China, Malaysia, Eurasia, Mexico, Singapore, and the U.K.

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

o   Patents have also been filed on extensions to the DPP®  product line

(see graphics)

Slide 7

Chembio-Branded Public Health Foundation Complemented by OEM and/or License Programs

Current OEM/Licensees:  Fiocruz (Brazil), BIORAD

Anticipated OEM/License Areas: Infectious Diseases, Veterinary

HIV SCREEN – HCV AB-AG DUAL DPP-  SYPHILIS - INFLUENZA

Slide 8

Lateral Flow Rapid HIV Tests

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

·   US Rapid HIV Test Market Growth Continuing as States Implement CDC Testing Recommendation

·   Only Two Other CLIA-waived Products

·   Products Sold Under Chembio Brands (STAT PAK® & SURE CHECK®)ex-US and by Alere, Inc. (formerly Inverness) in US.

Slide 9

Pipeline:  Chembio-Branded DPP® Products Anticipated Timelines – US Market

	2011	2012	US Market
DPP® HIV Oral Fluid	Clinical Trials Commenced 2010, Completing  Q1 & 2; Modular Submissions in Q1, 2 & 3	FDA Approval, CLIA waiver, US Market Launch	$70MM
DPP® Syphilis Screen & Confirm	Completing Validation Q1; Clinical Trials Q2-4	FDA Clearance & US Market Launch – Q1-2	$30MM
Dual DPP ® HCV Ag/Ab	R&D	R&D	TBD
DPP® Influenza A/B Antigen Detection	Completing R&D Q1, Validation Q2; Clinical Trials Q3-4	FDA Clearance & US Market Launch – Q1-2	$200MM

Significant International Market Opportunities As Well

Slide 10

Pipeline: OEM Contracts with FIOCRUZ Brazil Anticipated Timelines

Contract	2010	2011	Minimum Product Sales Req. to Complete Tech Transfer*
DPP® HIV Screening	Approved, Commercial Sales	Commercial Sales	$8.8MM
DPP® HIV Confirmatory	Approved	Commercial Sales	$4.7MM
DPP® Syphilis Treponemal	Agreement Signed December 2010	Approval, Commercial Sales	$7.4MM
DPP® Syphilis Treponemal/ Non-Treponemal		Submission, Approval
DPP® Canine Leishmaniasis	Submitted	Approved Q1'11, Commercial Sales	$2.1MM
DPP® Leptospirosis	Submission pending	Submission, Approval, Commercial Sales	$0.4MM

*Not a guaranteed minimum except for purposes of technology transfer

Slide 11

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 early 2012.  Manufacturing by Bio-Rad. Royalties Upon Commercial Sales
Multiplex Influenza Immune Status Product Developed for Battelle/CDC	Prototype Development Completed;  Prototype products being evaluated at CDC. Additional development work under consideration.
NIH Phase II Grant – Leptospirosis	$2.9MM 3 Year Grant awarded 6/2009.  Prototype Developed.  Further reagent discovery underway.  Approximately $1.7MM funding remaining in 2011 and 2012 if renewed as anticipated.  Chembio is principal grantee.
NIH Phase II Grant – Tuberculosis	$2.9MM, 3 Year Grant awarded Effective 3/1/2011.  Prototype Developed. Planning Multi-site Evaluations and Optimization, Validation and Commercialization.  Chembio is principal grantee.
Veterinary Diagnostic Applications	Preliminary Discussions
Platform Enhancements	Buffer Integration and “Dual DPP®” projects in progress

Slide 12

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 13

Financial Summary- First Quarter 2008-2011

·   Steady increases in Revenue and Gross Profit

·   Increased R&D expense in Q1’11 driven partially by increased Clinical Trials expense

·   Steadily improving new loss in Q1

(See Graphic)

Slide 14

Revenue Growth by Category: 2009 vs. 2010

(see graphic)

Slide 15

Revenue Growth by Category: Q1’10 vs. Q1’11

(see graphic)

Slide 16

Selected Balance Sheet Data

($ in millions)	Mar.’11		Dec. '10		Dec. '09		Dec. ‘08
Cash	$	2,797		2,136		1,068		1,212
Accounts Receivable		1,727		3,946		1,776		809
Inventories		1,592		1,349		1,556		1,819
Total Current Assets		176		205		4,667		4,068
Net Fixed Assets		772		813		580		881
Other Assets		611		636		1,068		968
Total Assets	$	7,675		9,086		6,315		5,915
Total Current Liabilities		1,760		3,076		3,173		2,402
Total Liabilities		1,939		3,277		3,227		3,338
Total Equity		5,736		5,809		3,088		2,577
Total Liabilities & Shareholders Equity		7,675		9,086		6,315		5,915

Slide 17

Anticipated Milestones 2011

•   Clinical & Regulatory Programs for Branded Products

‐   HIV PMA Modular Submissions

‐   Syphilis Clinical Trials

‐   Influenza Clinical Trials

•   Four OEM Product Approvals for and Product Sales to FIOCRUZ

•   New R&D & OEM Product Agreements

•   Continued US Lateral Flow HIV Test Market Share Gains & Potential New International Market Opportunities

Slide 18

Potential Impact of OEM & Branded Products on Revenue

(See graphic)

Slide 19

Organization & Management Team

Lawrence Siebert, CEO & Chairman

Richard Larkin, CFO

Javan Esfandiari, Sr. VP R&D

Rick Bruce, VP Operations

Tom Ippolito, VP Reg., QA/QC

Sandy Speer, Dir. Client Serv.

Dr. Gary Meller, Director

Katherine Davis, Director

TOTAL EMPLOYMENT Approx. 100

Research and Development – 18

Regulatory and Clinical QA & QC – 7

Sales, General & Administration – 7

Operations- 69

Slide 20

CEMI Selected Share Data

Ticker Symbol (OTC-QB)	CEMI.QB
Price 4/29/2011	$0.48
52-Week High	$0.580
52-Week Low	$0.159
Outstanding Shares	63.1
Market Capitalization	$36.6
Fully Diluted Shares	70.2
Management Holding	11.2
Average Daily Volume (3 months)	105,000

Options and Warrants	Amt.	Avg. Ex. Price
Options (3.64MM held by mgmt. & board)	5.21	$0.166
Warrants (1.75 expire 10/2011)	1.83	$0.503
Total Options & Warrants	8.24	.267

(See graphics)

Slide 21

Additional Slides (Appendix)

	March 31, 2011		March 31, 2010		December 31, 2010		December 31, 2009		December 31, 2008
TOTAL REVENUES	$ 3,635,681		$ 2,783,415		$ 16,704,703		$ 13,834,248		$ 11,049,571
GROSS MARGIN	1,926,342	53%	1,306,374	47%	8,100,699	48%	5,860,405	42%	3,851,721	35%
OPERATING COSTS:
Research and development expenses	1,290,142	35%	800,758	29%	2,586,308	15%	2,883,696	21%	2,605,343	24%
Selling, general and administrative expense	775,371	21%	661,848	24%	2,940,721	18%	2,659,382	19%	3,317,046	30%
	2,065,513		1,462,606		5,527,029		5,543,078		5,922,389
INCOME (LOSS) FROM OPERATIONS	(139,171)		(156,232)		2,573,670		317,327		(2,070,668)
OTHER INCOME (EXPENSES):	(3,126)		(1,094)		(60,326)		(8,267)		121,898
NET INCOME (LOSS)	(142,297)	-4%	(157,326)	-6%	2,513,344	15%	309,060	2%	(1,948,770)	-18%

Slide 22

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

·   Improved Performance vs. Only Oral Fluid Test Based on Multiple Studies

·   OTC Opportunity

·   US Clinical Trials Being Completed Q1-2 2011

o   Modular PMA Submission in Q1, 2, 3

o   Anticipated Approval 2012

(See graphic)

Slide 23

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 24

DPP® INFLUENZA Multiplex Flu A & B Test

•   Large Established Market for Flu A&B tests

•   Chembio’s First Antigen Detection Test with DPP®

•   Prototype Shows Improved Performance vs. Established Tests

•   Anticipate FDA Clearance mid-2012

Slide 25

Hepatitis-C (HCV)

•   Estimated 3MM HCV Infections in US

•   No HCV Point-of-Care Test in US Testing for Antigen (indicating active disease)

•   Chembio Participating in Various Studies to Assess Prototype Performance

•   R&D Continuing in 2011