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):  August 4, 2011 (August 4, 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 August 4, 2011, the Company issued a press release entitled “ChembioReports 2nd Quarter 2011 Results”.   A copy of the press release is furnished herewith as Exhibit 99.1.

On August 4, 2011 the Company posted a PowerPoint Presentation to their website entitled “Investor Presentation August 2011.”  A copy of the presentation is furnished herewith as Exhibit 99.2.

In addition, also on August 4, 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 “Chembio Reports 2nd Quarter 2011 Results” dated August 4, 2011.
99.2	Presentation entitled “Investor Presentation August 2011” dated August 4, 2011.
99.3	Investor Fact Sheet posted to the company website dated August 4, 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.

August 4, 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 2nd Quarter 2011 Results” dated August 4, 2011.
99.2	Presentation entitled “Investor Presentation August 2011” dated August 4, 2011.
99.3	Investor Fact Sheet posted to the company website dated August 4, 2011.

EX-99.1

Chembio Reports 2nd Quarter 2011 Results

Conference Call Scheduled for Thursday, August 4, 2011,

 at 10:00 a.m. Eastern Time

MEDFORD, N.Y (August 4, 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 June 30, 2011. Total revenues were $3.61million for the quarter ended June 30, 2011, which compares to total revenues of $3.75 million for the quarter ended June 30, 2010, a 3.6% decrease.

The Company recorded a net income of approximately $.19 million, or less than $0.01 per share, for the quarter ended June 30, 2011, compared to a net income of approximately $.62 million, or $0.01 per share, for the quarter ended June 30, 2010.   For the six months ended June 30, 2011, total revenues were $7.25 million which compares to total revenues of $6.53 million for the six months ended June 30, 2010, an 11% increase.  The Company recorded a net income of approximately $.05 million, or less than $0.01 per share, for the six months ended June 30, 2011, compared to a net income of approximately $.46 million, or $0.01 per share, for the six months ended June 30, 2010.

The Company had a 27% increase in Net Product Sales during the second quarter which resulted from a 10% increase in sales to Alere, Inc. of our FDA-approved rapid HIV tests for marketing in the U.S. and sales of our DPP products to Brazil.  This increase combined to produce a 107% increase in product gross margin dollars as compared to the second quarter of 2010. The product gross margin increased by 18 percentage points, from 29% in the second quarter of 2010 to 47% in the second quarter of 2011; overall gross margin was 56.7% for the three months ended June 30, 2011, a record for the Company.  The approximate $639,000 increase in Net Product Sales for the second quarter was offset by a decrease of $528,000 in R&D, milestone and grant revenue and a decrease of $246,000 in license and royalty revenue.

For the six months ended June 30, 2011, the Company has a 31.6% increase in Net Product Sales during the six months as a result of a 42% increase in sales to Alere, Inc. of our FDA-approved rapid HIV tests for marketing in the U.S. and sales of our DPP products to Brazil.   This increase combined to produce a 91.4% increase in product gross margin dollars as compared to the first six months of 2010. The product gross margin increased by 14 percentage points, from 31% in the first six months of 2010 to 45% in the first six months of 2011.  Overall gross margin was 55% for the three months ended June 30, 2011.

During the six months ended June 30, 2011, the Company’s cash balance remained reasonably consistent at approximately $2.13 million. The decrease was primarily as a result of increased inventories and $.88 million paid for the balance due on its HIV-2 license from Bio-Rad Laboratories, Inc. These decreases were partially offset by 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 previously-reported QTDP grant awards, and also as a result of approximately $.26 million of net non-cash expenses in the period, primarily depreciation and amortization.

Lawrence Siebert, Chembio’s Chief Executive Officer, commented, “While we are pleased with the 27% increase in net Product Sales, we were disappointed that we were unable to complete manufacturing and shipment of certain orders during Q2 that significantly limited our financial results.  As a result, our order backlog at the end of the second quarter was extraordinarily high. On the other hand, this should enable us to deliver strong growth in our product sales and overall results during the balance of 2011. We continue to move forward in developing our branded and OEM business strategy, with the clinical programs for our Chembio-branded public health products and new OEM opportunities utilizing our DPP® technology both progressing well.”

Financial Highlights for the Quarter ended June 30, 2011

·   Product sales for the quarter ended June 30, 2011 (second quarter) increased 27% to $2.97 million from $2.34 million in the same period of 2010.

·   R&D, milestone and grant revenues for the second quarter decreased to $.57 million from $1.10 million in the same period of 2010, and license and royalty revenue decreased to $.07 million from $.32 million.

·   The increased product revenue, offset by decreased R&D and licensing and royalty revenues, combined to produce gross margin dollars that were $.04 million, or 2%, lower ($2.05 million vs. $2.09 million) than the gross margin dollars in the comparable period in 2010.  Product gross margin increased by $.73 million, or 107% ($1.41 million vs. $.68 million), over the comparable period in 2010.

·   Research and development expenses increased by $.37 million, or 47%, to $1.16 million compared to $.79 million in the 2010 period.  The increase is primarily due to an increase of $.21 million in clinical trial expenses.

·   Selling General & Administrative Expenses increased marginally in the second quarter of 2011 as compared to the second quarter of 2010.

·   Operating income was approximately $.20 million in the second quarter of 2011 as compared to operating income in the second quarter of 2010 of $.62 million. In addition, net income was approximately $.19 million in the second quarter of 2011 as compared to a net income in the second quarter of 2010 of $.62 million.

Financial Highlights for the six months ended June 30, 2011

·   Product sales for the six months ended June 30, 2011 (six months of 2011) increased 31.6% to $5.99 million from $4.55 million in the same period of 2010.

·   R&D, milestone and grant revenues for the six months decreased to $1.16 million from $1.64 million in the same period of 2010, and license and royalty revenue decreased to $.10 million from $.34 million.

·   The increased product revenue, offset by decreased R&D and licensing and royalty revenues, combined to produce gross margin dollars that were $.58 million, or 17%, greater ($3.98 million vs. $3.40 million) than the gross margin dollars in the comparable period in 2010.  Product gross margin increased by $1.30 million, or 91% ($2.72 million vs. $1.42 million), over the comparable period in 2010.

·   Research and development expenses increased by $.86 million, or 54%, to $2.46 million compared to $1.59 million in the 2010 period.  The increase is primarily due to an increase of $.60 million in clinical trial expenses.

·   Selling General & Administrative Expenses increased by $.12 million or 9% in the first six months of 2011 as compared to the first six 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 $.05 million in the first six months of 2011 as compared to operating income in the first six months of 2010 of $.46 million. In addition, net income was approximately $.05 million in the first six months of 2011 as compared to a net income in the first six months of 2010 of $.46 million.

·   The June 30, 2011 cash balance was $2.13 million, and remained reasonably consistent to the balance at December 31, 2010.  This was primarily due to an increase in inventories and $.88 million paid for the balance due on its HIV-2 license from Bio-Rad Laboratories, Inc. While each of these items decreased cash, they were almost entirely offset by $2.32 million in cash provided from collections of accounts receivable.

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

Summary of Clinical, Development and Regulatory Activities

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.  We have now completed all of the non-clinical data required for submitting Module II, and we anticipate filing this module very soon. We experienced some delays in completing the clinical trials, so that we now will not finish the clinical trials until the fall. We have completed approximately 75% of the 3,000-patient clinical trial, and this must be 100% completed in order to submit the final Module III. We believe that the results of the clinical trial thus far indicate that the sensitivity and specificity of this product on all blood matrices will exceed the performance requirements for FDA approval. However, we believe that the performance of this product on oral fluid samples may or may not meet FDA approval requirements.  Alternatively, additional studies may need to be performed in order to achieve the oral fluid claim.  FDA approval of an oral fluid claim from the current or additional clinical trials will ultimately depend on several factors, including but not limited to the product performance in the remainder of the clinical trial, the assessment by FDA of such clinical trial data, and the product performance and procedural claims that the Company is seeking versus those that the FDA determines in its sole discretion are supported by the data.

DPP® Syphilis Screen & Confirm - We are engaged in a number of activities oriented to commercializing this product. Training, contracts and IRB approvals are in place to commence clinical trials in support of a 510(K) clearance of this product.  We anticipate the trials to be substantially completed during 2011 and FDA 510(K) clearance during 2012.    We have also submitted a CE Mark application to our notified body for this product, which we anticipate receiving within a few months.  This will facilitate our efforts to start commercializing this product outside the United States.    There has been an increasing debate in the public health community concerning the recommended sequence of tests used to screen and confirm for active Syphilis, which currently requires two separate, time-consuming laboratory tests.  We believe our patented DPP® Screen & Confirm Treponemal-Non-Treponemal test will be a welcome solution for addressing this important public health problem.

CE Mark for FDA approved HIV tests – The final studies for the CE Marking requirements for our Chembio-labeled HIV 1/2 STAT PAK® AND SURE CHECK® HIV 1/2 are complete and we will be submitting this data during August.

SURE CHECK® HIV 1/2 for Home Use – The Company has initiated studies required for submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration for its SURE CHECK ® HIV 1/2 rapid test as the first step toward over-the-counter (OTC) product approval. 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 has requested a meeting with the FDA to confirm and further clarify the process prior to submitting an IDE.

DPP® Influenza Immunity Test– Based upon the evaluation of our prototypes from the initial contract development work performed in 2010, in July we submitted a new proposal pursuant to a request from the same government contractor we performed the work for in 2010 related to additional research and development activities.

Conference Call

Chembio has scheduled a conference call and webcast for 10:00 a.m. Eastern time on Thursday, August 4, 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 August 11, 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 #: 376049.  The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=165190.  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. 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.

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 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 six months ended
	June 30, 2011		June 30, 2010		June 30, 2011		June 30, 2010
Net product sales	$	2,974,379	$	2,335,665	$	5,989,442	$	4,550,562
License and royalty revenue		71,468		317,472		100,322		338,968
R&D, milestone and grant revenue		568,304		1,096,305		1,160,068		1,643,328
TOTAL REVENUES	$	3,614,151	$	3,749,442	$	7,249,832	$	6,532,858
GROSS MARGIN	$	2,050,278	$	2,094,966	$	3,976,620	$	3,401,340
Research and development expenses	$	1,164,872	$	791,596	$	2,455,014	$	1,592,354
Selling, general and administrative expenses	$	688,259	$	680,014	$	1,463,630	$	1,341,862
NET INCOME FROM OPERATIONS	$	197,147	$	623,356	$	57,976	$	467,124
NET INCOME	$	194,839	$	621,917	$	52,542	$	464,591
Basic net income per share	$	0.00	$	0.01	$	0.00	$	0.01
Weighted average number of shares outstanding, basic		63,060,582		62,070,736		62,675,073		62,028,450

Chembio Diagnostics, Inc.
Summary of Balance Sheets
	June 30, 2011		Dec 31, 2010
	(Unaudited)
CURRENT ASSETS:
Cash and cash equivalents	$	2,139,329	$	2,136,351
Accounts receivable, net of allowance for doubtful accounts of $20,000 and $35,000 for 2011 and 2010, respectively		1,642,749		3,946,398
Inventories		2,917,473		1,349,161
Prepaid expenses and other current assets		214,626		204,824
TOTAL CURRENT ASSETS		6,914,177		7,636,734
FIXED ASSETS, net of accumulated depreciation		778,123		813,214
OTHER ASSETS
Deposits on equipment		156,536		-
License agreements and other assets		586,226		636,226
	$	8,435,062	$	9,086,174
TOTAL CURRENT LIABILITIES	$	2,078,676	$	3,076,457
TOTAL OTHER LIABILITIES		159,697		200,773
TOTAL LIABILITIES		2,238,373		3,277,230
TOTAL STOCKHOLDERS’ EQUITY		6,196,689		5,808,944
	$	8,435,062	$	9,086,174

Chembio Diagnostics, Inc.
Summary of Cash Flow
	For the six months ended (Unaudited)
	June 30, 2011			June 30, 2010
Net cash provided by (used in) operating activities	$	926,164		$	(431,648	)
Net cash used in investing activities		(288,402	)		(144,345	)
Net cash provided by (used in) financing activities		(634,784	)		254,606
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	$	2,978		$	(321,387	)

#   #   #

EX-99.2

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

•   Branded & Private Label (OEM) Strategy

•   Enabled by Patented Dual Path Platform (DPP®)

•   Four products approved in Brazil 2010-11 now being launched by Brazilian OEM partner

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

•   130 Employees

Slide 4

Financial Overview

·   Five Year Compounded Annual Revenue Growth of 33%

·   Gross Margin Expansion Actual and % Sales

·   2006: $1.60MM -           25%

·   2010: $8.10MM -           48%

·   2010 6 Mos. YTD -       $3.40MM -                                                                      52%

·   2011 6 Mos. YTD -      $3.98MM -            55%

·   Profitable 2009, 2010 and 2011YTD

(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   Chembio Pursuing FDA Approval of Sure Check® HIV Test for Self Testing by Consumers

•   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

•   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

Pipeline of 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

Chembio Branded Products in Clinical Trials

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

Slide 8

Lateral Flow Rapid HIV Tests

·   >20% 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

o   42% Increase YTD v. 2010

·   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	Y	N

Slide 10

Pipeline: Chembio-Branded Products Anticipated Timelines – US Market

Product	2011	2012	Est. Current & Potential U.S. Market Size
DPP® HIV Screen	Clinical Trials Commenced 2010, Completing  in Q4; Modular PMA Submissions in Q1’11, Q3’11 and Q4’11	FDA Approval, CLIA waiver, US Market Launch	$70MM/$150MM US POCT Market Developed into 7MM Unit Market since 2003
DPP® Syphilis Screen & Confirm	Clinical Trials Q3-4’11; 510(K) Submission	FDA Clearance & US Market Launch – Q3’11	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	Phase II Clinical Trials in 2012-2013	NA/$150MM Assumes $30 OTC Test

Significant International Market Opportunities As Well

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		Submitted, Approval, Commercial Sales	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 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	$2.4MM, 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 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

Financial Summary- First Quarter 2008-2011

·   Steady increases in Revenue and Gross Profit

·   Increased R&D expense in 2011YTD driven partially by increased Clinical Trials expense

·   Profitable Q2-2011 and YTD

(See Graphic)

Slide 15

Selected Comparative Operating Statement Items – 2010 vs. 2011

	3mos. June 30, 2011		3mos. June 30, 2010		June 30, 2011-YTD		June 30, 2010-YTD		December 31, 2010
Net Product Revenues	$     2,974,379		$     2,335,665		$     5,989,442		$     4,550,562		$      13,516,359
Non-Product Revenues	639,772		1,413,777		1,260,390		1,982,296		3,188,344
TOTAL REVENUES	$ 3,614,151		$ 3,419,442		$ 7,249,832		$ 6,532,858		$ 16,704,703
GROSS MARGIN	2,050,278	57%	2,094,966	61%	3,976,620	55%	3,401,340	52%	8,100,699	48%
OPERATING COSTS:
Research and development expenses	1,164,872	32%	791,596	23%	2,455,014	34%	1,592,354	24%	2,586,308	15%
Selling, general and administrative expense	688,259	19%	680,014	20%	1,463,630	20%	1,341,862	21%	2,940,721	18%
	1,853,131		1,471,610		3,918,644		2,934,216		5,527,029
INCOME FROM OPERATIONS	197,147		623,356		57,976		467,124		2,573,670
OTHER INCOME (EXPENSES):	(2,308)		(1,439)		(5,434)		(2,533)		(60,326)
NET INCOME	194,839	5%	621,917	18%	52,542	1%	464,591	7%	2,513,344	15%

Slide 16

Revenue Growth by Category: 2009 vs. 2010

(see graphic)

Slide 17

Revenue Growth by Category: Q2’10 YTD vs. Q2’11 YTD

(see graphic)

Slide 18

Selected Balance Sheet Data

($ in millions)	June.’11	Dec. '10	Dec. '09	Dec. ‘08
Cash	$2,139	2,136	1,068	1,212
Accounts Receivable	1,643	3,946	1,776	809
Inventories	2,917	1,349	1,556	1,819
Total Current Assets	6,914	205	4,667	4,068
Net Fixed Assets	778	813	580	881
Other Assets	743	636	1,068	968
Total Assets	$8,435	9,086	6,315	5,915
Total Current Liabilities	2,079	3,076	3,173	2,402
Total Liabilities	2,238	3,277	3,227	3,338
Total Equity	6,197	5,809	3,088	2,577
Total Liabilities & Shareholders Equity	$8,435	9,086	6,315	5,915

Slide 19

Anticipated Milestones 2011

•   Clinical & Regulatory Programs for Branded Products

‐   HIV PMA Modular Submissions

‐   Syphilis Clinical Trials

‐   Sure Check HIV OTC IDE

•   Commercialization of OEM Products

‐   2011 FIOCRUZ

‐   2012 BIO RAD

•   New Branded Product  Development

•   New R&D & OEM Product Agreements

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

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. 130

Research and Development – 24

Regulatory and Clinical QA & QC – 11

Sales, General & Administration – 8

Operations- 87

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 Revenue*

(See Graphic)

Slide 23

CEMI Selected Share Data

Ticker Symbol (OTC-QB)	CEMI.QB
Price 7/29/2011	$0.42
52-Week High	$0.580
52-Week Low	$0.210
Outstanding Shares	63.3
Market Capitalization	$26.6
Fully Diluted Shares	69.8
Management Holding	11.6
Average Daily Volume (3 months)	60,000

Options and Warrants	Amt.	Avg. Ex. Price
Options (3.89MM held by mgmt. & board)	5.42	$0.192
Warrants (MM)-Exp. Dates
10/06/2011	1.17	$0.454
02/05/2012	0.07	$0.810
Total Warrants (MM)	1.24	$0.475
Total Options & Warrants (MM)	2.41	$0.245

(See graphics)

Slide 24

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

·   Improved Performance Based on Multiple Studies

·   US Clinical Trials Being Completed in 2011

o   Modular PMA Submission in 2011

o   Anticipated Approval 2012

·   OTC Opportunity

(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 IDE Submission 2011; Clinical Trials Beginning 2012

•   Patented All-In-One Barrel Device

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

•   Alternative to Less Sensitive Oral Fluid Product from Only Competitor

•   Potential Clinical Trials, Submission to FDA, and Approval in 2012-14

(See graphic)