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):  January 7, 2013 (January 4, 2013)

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 January 4, 2013, the Company issued a press release entitled “Chembio to Present at Sidoti & Company, LLC 2013 Micro-Cap Conference”. A copy of the press release 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	Press Release entitled “Chembio to Present at Sidoti & Company, LLC 2013 Micro-Cap Conference”dated January 4, 2013.
99.2	Presentation entitled “Investor Presentation January 2013” dated January 7, 2013.
99.3	Investor Fact Sheet posted to the company website dated January 7, 2013.

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.

January 7, 2013                                                                                 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 to Present at Sidoti & Company, LLC 2013 Micro-Cap Conference”dated January 4, 2013.
99.2	Presentation entitled “Investor Presentation January 2013” dated January 7, 2013.
99.3	Investor Fact Sheet posted to the company website dated January 7, 2013.

EX-99.1

CHEMBIO TO PRESENT AT SIDOTI & COMPANY, LLC 2013 MICRO-CAP CONFERENCE

MEDFORD, N.Y. (January 4, 2013) – Chembio Diagnostics, Inc. (NASDAQ: CEMI),a leader in point-of-care (“POC”) diagnostic tests, today announced that Lawrence Siebert, Chief Executive Officer of Chembio,  will present a corporate overview at the Sidoti & Company LLC’s (www.sidoti.com) 2013 Micro-Cap Conference on Monday, January 7, 2013 at 2:10 p.m. Eastern time. The conference will be held at the Grand Hyatt Hotel in New York City.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $10 billion point-of-care testing market. Chembio’s two U.S. Food and Drug Administration (FDA), Pre-Market Approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by Alere, 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 170 employees, Chembio is licensed by the 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 additional information, please visit the Company’s website at 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, which are estimates only, 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:

Chembio Diagnostics

Susan Norcott

(631) 924-1135, ext. 125

snorcott@chembio.com

LHA

Anne Marie Fields

(212) 838-3777

AFields@lhai.com

@LHA_IR_PR

#   #   #

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 develop, manufacture, market and finance new products 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. Other 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

Investment Summary

•   Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)  Using Company's Patented DPP® Platform Technology

•   Current Revenues Primarily from HIV & Syphilis POCTs Sold Globally

•   Profitable FY2009-2011 & 9 Months of 2012

‐   Anticipate Strong Fourth Quarter 2012 Sales

•   Partnered with Leading License & Distribution Partners in U.S. & South America

•   Recent FDA Approval of Oral Fluid HIV Test

‐   First DPP® test approved by FDA

•   Strong Pipeline of POCTs

•   Experienced Management Team

Slide 4

Selected Financial Data FY2008 – 2011 & 9 Mos 2012

Anticipate Reporting Record Revenues Again for FY2012

See Graphics

Slide 5

POCT’s – A Growing Global Market

Converting Lab Tests to POC and Creating New Markets

Est. $10B Global POCT Market; >$45B Total In-Vitro DX Market

See Graphic

Slide 6

Chembio Target POCT Markets – 2013-2016

•   HIV

•   Significant Position with Lateral Flow Tests in US and Globally

•   DPP® Oral Fluid HIV Test FDA Approved 12/19/2012

•   $75MM US Market; $250MM Global Donor-Funded Market; Self-Testing Over-the-Counter Potential

•   Syphilis

•   High  Rates of Co-Infection with HIV, No POCT in U.S.

•   Two DPP® Products in Pipeline – Potential $75MM Market

•   Hepatitis-C

•   Potential  Baby Boomer Testing Cohort Represents  Potential 80MM 1x Testing Opportunity;  New Therapeutics

•   DPP® Product in development

•   Other New POCT Markets TBD in the US & Globally

Slide 7

New Product Commercialization Estimated Timelines – U.S. & International

2013

·   DPP® Oral Fluid and Blood Rapid HIV Assay CLIA Waiver & Launch

·   International

o   HIV-Syphilis

2014

·   DPP® Syphilis Screen/Confirm

·   DPP® HIV-Syphilis Assay

·   International

o   HIV OTC

o   HCV

2015

·   DPP® HCV Assay*

·   HIV OTC*

·   4th Gen. &/or Assays with New Detection and Reader Technologies

* Subject to ongoing market assessment

Complementing Strong US and Global Revenue Base

Slide 8

Chembio’s Patented Technology Platforms:

In-Licensed Lateral Flow and Patented Dual Path Platform (DPP®)

•   DPP® - A Patented POCT Platform Technology

‐   Enables Improved Performance, Multiplexing, Sample Control, Line Clearance, Detection Systems

‐   Validated with Numerous Partners, Regulatory Agencies

‐   Patents Issued in US and Multiple Countries

‐   Continuing Prosecution & Expansion of IP

See Graphics

Slide 9

Revenue Primarily from 3 FDA-Approved Rapid HIV Tests Sold Globally

•   Large International Screening Programs (PEPFAR)  - Distribution and Direct Sales

•   Lateral Flow Products in US Exclusive through Alere

•   DPP® FDA Approved Dec. 2012

‐   Marketing Options  - Direct  Sales and/or Distribution

See Graphics

Slide 10

Collaboration with FIOCRUZ in Brazil

•   Oswaldo Cruz Foundation  (FIOCRUZ)

‐   Key Supplier to Brazilian Federal Ministry of Health

‐   Aggregate of $23MM in DPP® Tech. Transfer Contracts

‐   Approximately 50% Completed  2011-2012

•   Potential New Products  & Collaborations  in Brazil with FIOCRUZ & Others

‐   Public Market

‐   Private Market

See Graphics

Slide 11

DPP HIV®1/2 Assay: FDA-Approved December, 2012

Clinical Trial Performance Data on Finger Stick Whole Blood and Oral Fluid samples

See Graphics

Analytical Data Show Detection of Sero-conversion Samples Earlier than all FDA Approved Lateral Flow HIV Tests

Slide 12

DPP HIV 1/2 Assay –Anticipated U.S. Launch – 2H:13

•   Uses Proprietary  SampleTainer™ Sample Collection System

•   Excellent Performance, Similar Procedure for All Sample Matrices

•   CLIA Waiver Studies Pending

•   Market Opportunity

‐   Become Preferred Oral Fluid HIV Test

‐   Demonstrate Earlier Detection Capability on Blood Samples

See Graphics

Slide 13

U.S. Rapid HIV Test Market

•   Estimated $75MM Market

‐   10% Average Annual Growth

‐   ~50,000 New Infections Annually

‐   Routine Testing Reimbursed

‐   Improved Treatments

•   Market Share Estimates

‐   Orasure - Market leader - 60% share

‐   Chembio’s Lateral Flow (Alere) - 25% share

‐   Trinity & Others -15%

•   Trend Toward  “4th Generation”  Assays

‐   Chembio Developing “D” DPP®

Slide 14

U.S. HIV Self-Testing  “OTC” Opportunity

•   Chembio Uniquely Positioned

•   Filing IDE Q1 2013 for Sure Check HIV

•   Pre-IDE Self-Testing Studies Show 100% Accuracy (n=300)

•   Can Also Pursue for DPP® Oral Fluid Test

See Graphics

Slide 15

Pipeline: DPP® Syphilis Screen & Confirm Test

•   First Dual POCT for Syphilis Enables Confirmation & Treatment At POC

•   CE Marked

•   FDA Meeting Q1 RE: Clinical Pathway

•   Clinical Trials and FDA Submission Anticipated 2013

•   Anticipated U.S. Market Launch 2014

See Graphics

Slide 16

Pipeline: DPP® HIV-Syphilis Multiplex Test

•   High Co-Infection Rates, Particularly in MSM

•   Adds Syphilis Test Line to Already FDA-Approved HIV Assay

•   Excellent Pre-Clinical Data

•   Discussing Regulatory Pathway with FDA-CBER & CDRH  Q1 -2013

See Graphics

Slide 17

Pipeline: Rapid Hepatitis C Point-of-Care Diagnostic

•   Data Published in Journal of Clinical Virology  showedgood performance of Chembio's 1st Generation Prototype Assay

•   Completed Feasibility to Establish Performance Comparable to Only POCT HCV Test – 2013 R&D to incorporate additional value-added features

•   Recent CDC recommendations for testing on everyone born between 1945-1964

•   Anticipated Timeline

‐   Development & Clinical Trials – 2013-2014

‐   US Market Launch Anticipated - 2015

See Graphic

Slide 18

New POCT Markets Will Require Even Lower Levels of Detection

Potential New POCTs: HIV 4th Gen., HCV, CT-NG, HSV, Maternal Health and Cardiac Markers Assays Incorporating Unique DPP® Features

See Graphics

Slide 19

Chembio is Investing in Developing the Capabilities to Meet Future POCT Market Requirements

Incorporating A Selected Detection Technology DPP® Prototype Has Achieved >16-fold Increase in Limit of Detection For a Virus Analyte

See Graphics

Slide 20

Future DPP® POCTs Will Be Connected to Readers to Record and Transmit Results

See Graphics

Slide 21

Strong Revenue & Operating Income Growth in FY 2012

•   Brazil Revenues  Up Significantly vs. 2011

•   Increased U.S. Sales Through Alere

•   Large International Orders Received in Q3-4 Shipped in Q4 and anticipate in Q1 2013

•   Strong Outlook for 2013

In (000’s)	YTD Sept. 30, 2012		YTD Sept. 30, 2011
Net Product Revenues	$16,919		$ 11,516
Non-Product Revenues	$     825		$ 1,655
TOTAL REVENUES	$17,744		$ 13,171
GROSS MARGIN	$  7,632	43%	$6,647	50%
OPERATING COSTS:
Research and Development exp	$ 3,364	19%	$3,697	28%
Selling, G&Administrative exp	$ 3,522	20%	$2,413	18%
	$ 6,886		$6,110
INCOME FROM OPERATIONS	$   746		$    537
OTHER INCOME (EXPENSES):	$      (2)		$      (9)
NET INCOME-Before Taxes	$  744	4%	$     528	4%
Income tax (benefit) provision	$  295		$     -
NET INCOME	$  449	3%	$     528	4%

Slide 22

CEMI Selected Share & Balance Sheet Data

(in millions except per share and daily volume data)

Ticker Symbol (NASDAQ)	CEMI
Price 12/31/12	$4.73
52-Week High	$5.80
52-Week Low	$3.10
Outstanding Shares	8.00
Market Capitalization	$38.8
Fully Diluted Shares	8.8
Management Holding	1.6
Average Daily Volume (3 months)	52,000

Options	Amt.	Avg. Ex. Price
578K held by Mgmt. & Board	764K	$2.08

($ in millions)	Sept.’12	Dec'11	Dec. '10
Cash	$  3,290	$     3,011	$    2,136
Total Current Assets	9,601	8,992	7,637
Total Assets	$16,140	$   15,486	$    9,086
Total Current Liabilities	2,761	2,858	3,076
Total Liabilities	2,856	2,991	3,277
Total Equity	13,284	12,495	5,809
Total Liabilities & Stockholders’ Equity	$16,140	$   15,486	$    9,086

See Graphics

Slide 23

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
Sharon Klugewicz	VP QA/QC & Technical Operations	2012
Rick Bruce	VP Operations	2000
Michael Steele	VP Sales Marketing & Bus. Dev.	2012

Independent Directors                                                                                     Joined Board:

Gary Meller, MD, MBA	2005
Katherine Davis, MBA	2007
Barbara DeBuono, MD, MPH	2011
Peter Kissinger, Ph.D	2011

Slide 24

Organization & Facility

•   FDA & USDA- Approved Development & Manufacturing Facility

•    28,000 Sq. Ft. Leased Facility in Medford, NY

Total Employment: Approx. 170

Reg. & Clinical QA &QC	15
SG&A	11
Research & Development	29
Operations	116

See Graphics

Slide 25

Investment Summary

•   Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)  Using Company's Patented DPP® Platform Technology

•   Current Revenues Primarily from HIV & Syphilis POCTs Sold Globally

•   Profitable FY2009-2011 & 9 Months of 2012

‐   Anticipate Strong Fourth Quarter 2012 Sales

•   Partnered with Leading License & Distribution Partners in U.S. & South America

•   Recent FDA Approval of Oral Fluid HIV Test

‐   First DPP® test approved by FDA

•   Strong Pipeline of POCTs

•   Experienced Management Team

See Graphic

Slide 26

Investment Summary

•   Develops, Manufactures & Markets Point-of-Care Diagnostic Tests (POCTs)  Using Company's Patented DPP® Platform Technology

•   Current Revenues Primarily from HIV & Syphilis POCTs Sold Globally

•   Profitable FY2009-2011 & 9 Months of 2012

‐   Anticipate Strong Fourth Quarter 2012 Sales

•   Partnered with Leading License & Distribution Partners in U.S. & South America

•   Recent FDA Approval of Oral Fluid HIV Test

‐   First DPP® test approved by FDA

•   Strong Pipeline of POCTs

•   Experienced Management Team

See Graphic

Chembio Diagnostics, Inc.

RAPID tests for EARLIER treatments

Thank You

EX-99.3