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 29, 2010 (November 29, 2010)

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 29, 2010, the Company posted a PowerPoint Presentation entitled “Investor Presentation December 2010” to its website.  A copy of the presentation is furnished herewith as Exhibit 99.1.

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 PowerPoint Presentation entitled “Investor Presentation December 2010”

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.

Date:  November 29, 2010                                                  

 Chembio Diagnostics, Inc.

By:    /s/ Lawrence A. Siebert                                      

Lawrence A. Siebert

Chief Executive Officer

EXHIBIT INDEX

Exhibit Number	Description
99.1	PowerPoint Presentation entitled “Investor Presentation December 2010”

EX-99.1

Exhibit 99.1 - SEE PDF

Slide 1:

Investor Presentation

November 2010

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:

•   Medford, NY  Manufacturer of Point of Care Rapid Diagnostic Tests

•   Five Year Revenue CAGR of 33%

•   FY 2009 Total Revenues of $13.8MM

•   Profitable in 2009 and 2010YTD through Sept. 30

•   Anticipate $15MM+ Revenues in 2010

•   68% of Revenues from FDA Approved Rapid HIV Tests Marketed Globally

•   in U.S. by Alere (formerly Inverness Medical)

•   Near & Long Term Catalysts

•   Product Launches Using Chembio’s Patented DPP® Rapid Test Platform

Slide 4:

FDA Approved Rapid HIV Tests

Distributed in US Exclusively by Inverness Medical

•   148% Revenue Increase in 2009 to $5.3MM

–   20% Market Share

•   Competitive Features

–   CLIA Waived

–   Two Formats

–   99.7% Sensitivity; 99.9% Specificity

–   Proprietary Formulation Enables 24 Month Stability

–   Strong Marketing Partner

Marketed Ex-US Directly by Chembio through Distributors

 Slide 5:

PATENTED DUAL PATH PLATFORM (DPP®)

KEY DESIGN AND PERFORMANCE ADVANTAGES vs. LATERAL FLOW

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

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

•   US Patent #7,189,522. Patents Issued or Pending in all major markets

Slide 6:

Dual Path Platform DPP® vs. Lateral Flow

•   Dual Path Platform

–   Chembio is a Licensor

–   Basis for Branded & OEM Product Pipeline

•   Lateral Flow Platform

–   Chembio is a Licensee

•   Alere Sells in US

•   Ex-US Chembio Pays Alere either 8.5% or 5% Royalty

 Slide 7:

Pipeline from DPP® Technology

•   2011-2012

–   Launch of  Oral Fluid HIV Test and for Syphilis Tests & Establish Chembio DPP® Public Health Brand

–   International DPP Revenues – Brazil

–   Influenza Ag & Ab Tests

•   2012-2014 –

–   Grow Chembio DPP® Public Health Brand

–   Launch HIV OTC, Hepatitis C, Influenza Ag & Ab

•   2010-2014 – Participate in New Markets Via OEM Agreements, Strategic Alliances, M&A

–   Respiratory, Cardiac, Auto-Immune

–   Veterinary, Food, Environmental

–   Readers

–   Molecular Technologies

Slide 8:

DPP® HIV 1/2 Oral Fluid Assay

•   $60MM/6MM Unit US Market Growing ~15%/Year

•   International Studies Completed in 2009

•   US Clinical Trials Commenced Q1 2010

•   Anticipate PMA approval 2011-12

•   OTC Opportunity

Slide 9:

DPP® Syphilis Screen & Confirm

•   First POCT For Syphilis In US – Estimate $30MM Potential Market

•   Provides Better Indication Of Active Disease

•   Enables Confirmation & Treatment At POC

 •   Pre-natal Testing

 •International Evaluation Ongoing

 •Anticipate 510(K) Clearance in 2011

 Developed in collaboration with the U.S. Centers for Disease Control

 Slide 10:

OEM Contracts with FIOCRUZ

•   Four Products Under OEM Agreements with FIOCRUZ

–   Following Successful $8MM Tech. Transfer Program Completed 2004-2009

•	Two Regulatory Approvals in Brazil Received June, Sept of 2010
– –		Initial Order in Production for Q4 2010 Shipment Possible Additional Approval and New Products Agreement in Q4

Slide 11:

In Development: DPP® INFLUENZA

Multiplex Flu A & B Test & 6 Strain Immunity Test

•   Large Established Market for Flu A&B tests

•   Chembio’s First Antigen Detection Test with DPP

•   Prototype Shows Improved Performance  v. Established Tests

•   In Addition: $900,000 Contract signed Dec. 2009 with CDC for 6-band Multiplex Immune Status Test

 Slide 12:

In Development: Hepatitis-C (HCV) & HIV/HCV Comb.

Oral Fluid

•   Estimated 3MM HCV Infections in US

–   Only 22% Diagnosed

–   25% Co-infection with HIV

–   Major Cause of Liver Disease

–   New therapeutics from Vertex, etc. will drive demand for Dx

•   No HCV Point of Care Test in US

•   Chembio Participating in Pre-Clinical CDC Study with both prototypes – Data Being Submitted for Publication

Slide 13:

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

Europe $3,254 (52%), U.S. Hosp. $1,772 (28%), U.S. Decentralized Sites $591 (9%), etc (see PDF for more details).

At 7% Projected Increases, even with Large Low-Growth Segments (e.g., Glucose), Global POCT Market is Fastest Growing Segment of $39.5B In-Vitro Diagnostics Market, Projected to Reach $8.8B by 2012

Source: Independent Market  Research Report

Slide 14:

Financial Summary

•   Historical 2005-2009 - >33% Five CAGR Sales

–   Became Profitable Q2-4 2009 and for full FY 2009 148% Increase in Sales to Alere, R&D Income, Controlled SG&A    

•   September 30, 2010 YTD

–   Net Income of $632K on Total Revenue of $11.04MM

–   Improved Gross Margins YTD from Increased R&D Income Despite Decreased Int'l. Product Sales

–   Controlled SG&A  

  Slide 15:

Financial Summary

• Q4 2010 & FY2010 Revenue Outlook

- Anticipate > $15MM in Total Revenues vs. $13.8MM in 2009

- CDC Grants to States Improving.  Anticipate Q4'10 Revenues from Alere of at least $1.9MM in Q4 2010 compared with $1.8MM in Q4'09

- >75% Increase in 2010 Revenues from Products Serving Africa Markets

• Q4-2010 & FY2010 Operating Results Outlook

- Strong Order Backlog should result in operating efficiencies

  - New assembly automation anc cost savings implemented

- Impact of $1.467MM in QTDP Grants Awarded 11/1/2010

- Oral Fluid HIV Test Clinical Trial Expenditures of at least $200K

 Slide 16:

Selected Comparative Historical Financial Results

			For the Years Ended
$	(000s	)		2009			2008			2007			2006
Total Revenues			$	13,834		$	11,050		$	9,231		$	6,503
Cost of sales				7,974			7,198			6,435			4,894
Gross Profit				5,860			3,852			2,796			1,609
				42.4	%		34.9	%		30.3	%		24.7	%
R&D Expense				2,884			2,605			1,907			1,402
SG&A Expense				2,659			3,317			3,765			4,787
Operating Income (Loss)				317			(2,071	)		(2,876	)		(4,580	)
Other Inc. (Expense)				(8	)		122			249			(415	)
Net Income (Loss) - Stkhldrs				309			(1,949	)		(2,627	)		(4,995	)
Pref. Stock Expenses				-			-			5,645			3,210
Net Loss			$	309		$	(1,949	)	$	(8,272	)	$	(8,205	)
Net Income (Loss) - per Share			$	0.00		$	(0.03	)	$	(0.57	)	$	(0.80	)
Avg. No. Shares (Millions)				61.946			61.267			14.608			10.293
Working capital			$	1,494		$	1,664		$	3,229		$	5,113
Total assets				6,315			5,915			6,585			7,907
Total liabilities				3,227			3,338			2,322			2,297
Equity (Deficit)				3,088			2,577			4,263			(940	)

 Slide 17:

Selected Comparative Historical Financial Results

	Three Mos Ended						Nine Mos Ended
$(000s) - UNAUDITED	Sept 30 2010			Sept 30 2009			Sept 30 2010			Sept 30 2009
Net Product Sales	$	3,787		$	3,924		$	8,337		$	9,245
License & royalty revenue		62			31			401			84
R&D milestone and grant revenue		657			408			2,300			954
Total Revenues	$	4,506		$	4,363		$	11,038		$	10,283
Cost of sales		2,296			2,494			5,428			6,053
Gross Profit		2,210			1,869			5,610			4,230
		49.0	%		42.8	%		50.8	%		41.1	%
R&D Expense		1,230			778			2,822			2,128
SG&A Expense		802			784			2,144			2,002
Operating Income		178			307			644			100
Other Inc. (Expense)		(9	)		(1	)		(11	)		(8	)
Net Loss	$	169		$	306		$	633		$	92
Basic earnings-per share	$	0.00		$	0.00		$	0.01		$	0.00
Diluted earnings-per share	$	0.00		$	0.00		$	0.01		$	0.00
Basic Avg. No. Shares (Millions)		62.147			61.945			62.068			61.945
Diluted Avg. No. Shares (Millions)		70.547			75.366			71.074			74.938

 Slide 18:

Selected Balance Sheet Data

($000s)	UNAUDITED
Balance Sheet Data	Sept. '10		Dec. '09
Cash	$	1,336	$	1,068
Accts. Receivable		2,635		1,776
Inventories		1,883		1,556
Other Current Assets		191		267
Total Current Assets		6,045		4,667
Net Fixed Assets		828		580
Other Assets		690		1,068
Total Assets		7,563		6,315
Total Current Liab.		3,453		3,173
Total Other Liab.		221		54
Total Liabilities		3,674		3,227
Total Equity		3,889		3,088
Total Liabilities & Shareholders Equity	$	7,563	$	6,315

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: 101

S, G&A 7

Ops. 69

R&D 18

Reg. & Clinical, QA & QC 7

Slide 20:

CEMI Selected Share Data

Ticker Symbol (OTCBB)	CEMI
Price 10/29/10	$0.255
52 Week High	$0.390
52 Week Low	$0.159
Outstanding Shares (MM)	62.2
Market Capitalization	$15.9
Fully Diluted (FD) Shares	70.5
Management Holding-FD	11.3
Average Volume (3 Mos)	54,000
Options and Warrants (MM)		Avg. Ex. Price
Options (3.95MM held by mgmt. & board)	5.71	$0.168
Warrants  - Exp. Dates
10/6/2011	2.54	$0.475
2/5/2012	0.07	$0.810
Total Warrants	2.61
Total Options & Warrants	8.32

 Slide 21:

SUMMARY

www.chembio.com

•   Top Line Growth for last 5 Years; Became Profitable in 2009 & through 9/30/2010 YTD

•   Platform Point of Care Technology DPP®

–   Robust DPP ®Product Pipeline for Branded & OEM Products

–   Licensing Revenues

•   Anticipated Near and Long Term Growth Catalysts from New Collaborations, Product Launches, Regulatory Submissions & Approvals