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 6, 2013 (October 31, 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:

  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 5.07 SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

At the Company's annual stockholder meeting on October 31, 2013, stockholders elected directors of the Company to serve until the next annual meeting of stockholders or until their respective successors are elected and qualified.  Stockholders also ratified the selection of BDO USA LLP as the Company's independent registered certified accountants to audit the Company's financial statements as of and for the year ending December 31, 2013, and approved, on an advisory basis, the compensation paid to the Company's named executive officers.  The stockholders also approved a one (1) year frequency time period for future advisory votes by stockholders concerning compensation paid to the Company's named executive officers.  A tabulation of the matters voted on at this annual stockholder meeting is set forth below.

Proposal #1:– Election of Directors	Kathy L. Davis	Barbara D. DeBuono	Peter Kissinger	Dr. Gary Meller	Lawrence A. Siebert
For	4,102,381	3,799,133	4,121,993	3,983,415	3,980,253
Withheld/Against	31,755	155,003	12,143	150,721	153,883
Broker non-votes	3,731,397	3,911,397	3,731,397	3,731,397	3,731,397

Proposal #2-6:	Ratifying BDO USA LLP as the Company's Independent Auditors for the year ending December 31, 2013	Approve Compensation  paid to the Company's named Executive Officers	Approve One Year frequency to approve Compensation paid to named Executive Officers	Vote to Adjourn Or Postpone the meeting	Vote on Other Business
For	7,838,094	3,494,733	2,159,884	7,037,329	6,064,543
Withheld/Against	15,775	489,260	1,886,660	735,471	1,706,183
Abstain	11,664	149,830	87,592	92,733	94,807
Broker non-votes	-	3,731,710	3,731,397	-	-

ITEM 7.01.  REGULATION FD DISCLOSURE.

On October 31, 2013, the Company issued a press release entitled "Chembio Launches DPP® HIV-Syphilis Test". A copy of the press release is furnished herewith as Exhibit 99.1.

On October 31, 2013, the Company presented a PowerPoint Presentation to the stockholders entitled "Annual Meeting of Shareholders". A copy of the presentation is furnished herewith as Exhibit 99.2A and Exhibit 99.2B.

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 Launches DPP® HIV-Syphilis Test" dated October 31, 2013.
99.2A	Presentation entitled "Annual Meeting of Shareholders" dated October 31, 2013 (Word version).
99.2B	Presentation entitled "Annual Meeting of Shareholders" dated October 31, 2013 (PDF version).

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 6, 2013                                                Chembio Diagnostics, Inc.

By:    /s/ Lawrence A. Siebert                                      

Lawrence A. Siebert

Chief Executive Officer

EX-99.1

    

Chembio Launches DPP® HIV-Syphilis Test

Receives First Purchase Order from Mexican Distributor

 Multiplex HIV-Syphilis Assay Approved for USAID Waiver List, Now  Eligible for U.S. Global Aid Procurements

MEDFORD, N.Y., October 31, 2013 -- Chembio Diagnostics, Inc. (Nasdaq:CEMI) a leader in the development, manufacture and marketing of point-of-care diagnostic tests ("POCT") for infectious diseases, announced today that the company received its first purchase order for its DPP® HIV-Syphilis Assay from its distributor in Mexico .  The DPP® HIV-Syphilis Assay is based on the company's patented Dual Path Platform (DPP®), a POCT platform that is well suited for multiplexing, and that in this case adds a syphilis biomarker to the company's already FDA-approved DPP® HIV 1/2 test.  The addition of this marker has resulted in a unique finger-stick whole blood test that can help reduce the transmission of both HIV and syphilis from mother to child.  Globally, more pregnant women are infected with syphilis than HIV, and pre-natal testing is an essential tool to help prevent transmission of both diseases to the unborn child.

The DPP® HIV-Syphilis Assay has also been approved for inclusion on the United States Agency for International Development ("USAID") waiver list, which to the Company's knowledge is the first HIV-Syphilis product to be included on this list according to the USAID's most recently published waiver list.  This approval makes this product eligible for procurements by U.S. government-funded global health programs such as the President's Emergency Plan for AIDS Relief (PEPFAR) and its affiliated programs and stakeholders.  USAID approval involves laboratory studies of product performance performed by the International Laboratory Branch of the United States Centers for Disease Control ("CDC") across multiple production lots to ensure consistent performance.  The Company anticipates that the results from the CDC's evaluation will be published in due course.  Chembio is also pursuing CE Marking and FDA approval of this product.

The purchase order from Mexico follows the previously reported favorable evaluation of the sensitivity and specificity of this test by Mexico's Institute of Epidemiological Diagnosis and Reference (InDRE).  In the InDRE's testing, the Chembio DPP® HIV-Syphilis test performed with 100% sensitivity and 100% specificity on all samples.

"We believe the results of InDRE's tests together with the USAID waiver list approval provide a compelling validation of the Chembio DPP® HIV-Syphilis product for global health programs," stated Javan Esfandiari, Chembio's Senior Vice President of Research & Development. "We also look forward to developing many opportunities for this product around the world where there is a great need for detecting both HIV and syphilis in prenatal testing programs, and the USAID approval will help facilitate these opportunities. "

To facilitate product expansion into other markets worldwide, Chembio continues to make good progress toward having this product also approved by the World Health Organization for procurement by other large donor-funded global health screening programs. The company is also working directly in several regions of the world to develop and inform stakeholders about the availability of this innovative product.   Information concerning this product can be viewed at http://chembio.com/products/human-diagnostics/dpp-hivsyphilis-assay/.

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 FDA PMA-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 U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485. For more information, please visit: www.chembio.com.

Forward-Looking Statements

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

Susan Norcott

(631) 924-1135, ext. 125

snorcott@chembio.com

Vida Strategic Partners (investors)

 Stephanie C. Diaz

(415) 675-7401

sdiaz@vidasp.com

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

Leadership Executive Team

Executive:  Lawrence Siebert, J.D.  Chairman  & CEO

Previous Experience: 1981-1991, Partner, Stanwich Partners, Inc.; 1992-2002 Siebert

 Associates LLC, Manager; Siebert Capital Corp., President

Joined:  2002

Executive:  Richard Larkin, CPA  Chief Financial Officer

Previous Experience: 2000-2003  CFO of Visual Technology Group; 1987-2000 CFO of Protex  International Corp.

Joined:  2003

Executive:  Sharon Klugewicz, M.S.  Chief Operating Officer

Previous Experience: 20+ Years at Pall Corporation, most recently as Sr. VP - Scientific & Laboratory Services

Joined:  2012

Executive:  Javan Esfandiari, M.S.  SVP Research & Development

Previous Experience: 1993-1997, R&D Director On-Site Biotech;

1997-2000, Co-Founder of Sinovus Biotech AB (Sweden), which was acquired by Chembio in 2000

Joined:  2000

Executive:  Thomas Ippolito, VP Regulatory & Clinical Affairs

Previous Experience: 25 years' experience in the development of vaccines, therapeutics and  IVDs working with several major pharmaceutical, vaccine and diagnostic companies

Joined:  2005

Executive:  Michael Steele

Previous Experience: 20-years of business development and strategy execution at life sciences companies Sera Care Life Sciences, Serologicals, Inc. and Corautus Genetics.

Joined:  2012

Slide 4

Leadership Independent Directors

Gary Meller, M.D., MBA – Director since 2005, Member of: Chairman Compensation Committee, Audit Committee and Nominating and Corporate Governance Committee

President of CommSense Inc., M.D. University of New Mexico School of Medicine, MBA Harvard Business School.

Katherine L. Davis – Director since 2007, Member of: Chairman Audit Committee, Compensation Committee and Chairman Nominating and Corporate Governance Committee

Owner of Davis Design Group LLC;  MBA Harvard Business School, Bachelors of Science in Mechanical Engineering from the Massachusetts Institute of Technology.

Peter Kissinger Ph.D. –Director since 2011, Member of: Audit Committee

Professor of Chemistry and Associate Department Head at Purdue University; B.S. in Chemistry from Union College, Schenectady, N.Y., and a Ph.D. in Analytical Chemistry from the University of North Carolina in Chapel Hill.

Barbara DeBuono M.D., M.P.H. – Director since 2011, Member of: Compensation Committee, Chairman of Special Sub-Committee for CEO Search

Senior Vice President for Market Development at TREO Solutions ; B.A. from the University of Rochester, M.D. from the University of Rochester School of Medicine, and Masters in Public Health (M.P.H.) from Harvard University School of Public Health.

Slide 5

Our Vision & Mission

We are a provider of Point-of-Care diagnostic tests and solutions, helping people live longer and healthier lives.

Our mission is to become a key provider in the market for rapid diagnostic Point of Care (POC) testing, through the development, manufacture, and commercialization of proprietary technology with superior performance and technical service.

Slide 6

Current Financial Position and Share Information

Third Quarter Financial Results to be Issued November 7, 2013

($ in 000s)	June'13 Unaudited		Dec '12
Cash	$	8,645	$	2,952
Total Assets	$	23,542	$	17,335
Total Liabilities	$	3,929	$	3,460
Stockholders' Equity	$	19,613	$	13,875

(Share Information as of October 25, 2013mation2013 Revenuese convernsitsuctsrformance and technical seviceugh the development,)

Ticker Symbol (NASDAQ)	CEMI
Outstanding Shares	9.32 million
Fully Diluted Shares	9.99 million
Share Price	$	3.75
Market Capitalization	$34.96 million

Slide 7

Selected Financial Data FY2008 –2012

Nine Consecutive Years of Sales & Gross Profit Growth; Four Consecutive Years of Profitability

See Graphic

2012

 Total Revenue $25,611

 Product Revenue $24,327

 Gross Profit $10,790

 R&D Expense* $4,486

 Pre-Tax Income $1,451

 Clinical Trial Expense $820

*Non-recurring 2010 $1.5MM R&D Credit from the Affordable Care Act – excluded from 2010 R&D Exp. & 2010 Pre-Tax Income

Slide 8

Selected Actual & Anticipated Developments 2012 & 2013

 Strengthened Management Team

 Received FDA PMA Approval of DPP Oral Fluid HIV Test

 Achieved  9th Straight Year of Revenue & Gross Margin Growth and 4th Straight Year of Profitability ; Anticipate Record Revenues Second Half of 2013

 Strengthened Balance Sheet with Common Stock Issuance

 Established Institutional Shareholder Base

 Selected for Russell Small Cap Index

 Received CE Mark for Sure Check HIV 1/2 Assay – Additional CE Markings Anticipated

 Entered International Assembly & Distribution Agreement with Labtest of Brazil

Slide 9

Selected Actual & Anticipated Developments 2012 & 2013, continued

 Final USPSTF Recommendations for HIV and HCV Testing Issued, Complement CEMI Business Strategy for these Products

 Implementing US and International Commercial Strategy, Expanding Market and Sales Opportunities

 Anticipate Completing CLIA Waiver Study for DPP HIV Oral Fluid HIV Assay

 Anticipate Completing Initial International Registrations for HIV-Syphilis  & Receiving Initial Orders, and Submitting PMA Application to FDA

 Expanded DPP® IP Portfolio; Completing Sponsored Research Agreements

Slide 10

Chembio Products are well Positioned Globally for Growth…

USA

• Distribution through Alere (36% FY12 revenue)

• DPP® HIV PMA approval (Dec'12) / CLIA pending

• Funded Research Collaborations with CDC, DOD, NIH

• EUCE mark approval for SURECHECK ® (July '13)

• CE mark for STATPAK ®, DPP ® HIV, HIV/Syphilis pending.

SOUTH/CENTRAL AMERICA

• Strong OEM Partnerships (FIOCRUZ, Labtest); Branded products sold to NGOs, private distributors (>50% FY12)

AFRICA

• Procurement primarily funded by PEPFAR, Global Fund, and WHO

• Sales channel; NGO-direct & through distributors (11% FY12 revenue)

• Commercial resource deployment

Slide 11

DPP® Patented Point of Care Technology – POCTs for Early Detection & Improved Health

• Proprietary Platform Technology that Uniquely Enables Multiplexing for Higher Value Tests

• Increases Sensitivity as Compared with Lateral Flow Technology

• Validated with Numerous Partners, Regulatory Agencies

• New DPP® Patents Issued in 2013

See graphics

Slide 12

POCTs - A Growing $8B Global Market - Long-term Trend Toward Molecular Levels of Detection

CURRENT CAPABILITIES

 Lateral Flow Technology

 Single parameter tests

 DPP® Technology Enabling

 Improved Sensitivity, Multiplexing

R&D

 Signal

 Enhancement  Features

POTENTIAL NEW CAPABILITIES BEING ASSESSED

 Molecular

 Amplification Technologies

Slide 13

Chembio POCT Market Opportunities:

HIV Rapid POCTS

Established, Growing Markets

U.S.

• ~50,000 New Infections in - 2012

• USPSTF Recommends Routine Testing

‐ ACA Expanding Coverage by 25MM+

International

•  2.5MM New Infections Worldwide in 2012

•  Designation in PEPFAR & Other Donor-Funded Countries' Testing Protocols

Slide 14

Chembio DPP® HIV 1/2 Assay FDA-Approved Dec. '12, CLIA Waiver expected Q1 2014

 Build on Established Position/Performance of our FDA Lateral Flow Products with Only  Alternative to Current ~$35MM Oral Fluid Product

 Superior blood matrix performance over top 4 market share products in early detection study

 Superior Oral Fluid sensitivity v. Market Leader in head-to-head study

 User friendly, safe and efficient SampleTainer™ Sample Collection System

 Separate and reagent-free oral fluid collection device

See graphics

Slide 15

Additional POCT Products in Pipeline

Chembio's DPP® HIV-Syphilis and Syphilis Screen & Confirm Tests

DPP® HIV-Syphilis POCT

• Large Global Market Opportunities for Pre-Natal and MSM Screening; Up to 70% HIV-Syphilis Co-Infection in MSM

• Higher Prevalence of Syphilis (1.9MM) than HIV (1.5MM) in pregnant women

• International Registrations Pending; Anticipated FDA PMA submission in Q4 2014

DPP® Syphilis Screen & Confirm POCT

• Eliminates Past Infections, thereby Overtreatment

• CE Marked, Anticipate 510(K) Submission in Q1-2014

‐ Vendor Component Performance being Re-Validated with good process in Q3

Slide 16

Chembio's Business Strategy for Growth:

• Establish commercial capabilities to increase revenue and maximize profits

• Develop, license or acquire POCT products/technologies that add value

• Expand manufacturing capabilities to supply our customers

Slide 17

Commercial Strategy: Top Line Growth (Sales)

Build a Sales & Marketing Organization to increase Our Revenue and Maximize Profits

Tactic #1 Move up value stream in US diagnostics market "USA Direct" for certain products.

Tactic #2 Future Growth – New Markets and New Applications

Tactic #3 Maximize Opportunities Developing World Markets

Slide 18

US Market Commercial Launch Update

 US Launch Project Plan in Place

 Director of Sales & Director of Marketing Candidates Finalized

 Engaged with Distribution Partners

 Ongoing Discussion and Planning around Alere Options

o Anticipating Proposal from Alere

o Ongoing Assessment/Readiness for Alternative Scenarios & Options

Slide 19

Additional Priorities & Areas of Focus: Operations

Maufacturing Operations

 Process Excellence Program (Lean/Six Sigma)

 Engineering & Automation

 Targeted Cost Savings

o Productivity/Labor Efficiencies

o Scrap (10% Improvement from FY12)

Slide 20

Additional Priorities & Areas of Focus: Technology

Technology Investment

 New Product Launch (DPP HIV/SYP, SYP S&C)

 Develop New Technologies (HIV 4G, HCV) that Address Healthcare Concerns

 Identify Additional Technologies to License/Acquire that will Complement our Commercial Strategy

Slide 21

Anticipated Milestones - 2013-2014

• Record Revenues in Second Half of 2013

• Oral Fluid HIV Test CLIA Waiver & Launch

‐ Establishing Chembio-branded U.S. Public Health Commercial Organization for Pipeline of Complementary Products

• Expanding International Revenues for Lateral Flow and DPP® Products

• FDA Submission & Approval of DPP HIV-Syphilis Test

• New Distribution, Contract Development & OEM Deals

• Increased Production Capacity

• Pursue Acquisitions or Licenses of Complementary Products/Technologies

• New CEO