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 12, 2016 (May 12, 2016)

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 7.01.  REGULATION FD DISCLOSURE.

On May 12, 2016, the Company issued a press release entitled "Chembio Diagnostics Reports First Quarter 2016 Financial Results".   A copy of the press release is furnished herewith as Exhibit 99.1

On May 12, 2016, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation May 2016."  A copy of the presentation is furnished herewith as Exhibit 99.2.

In addition, also on May 12, 2016, the Company posted an Investor Fact Sheet to their website.  A copy of the fact sheet is furnished herewith as Exhibit 99.3

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

Exhibit Number	Description
99.1	Press Release entitled "Chembio Diagnostics Reports First Quarter 2016  Financial Results" dated May 12, 2016
99.2	Presentation entitled "Investor Presentation May 2016" dated  May 12, 2016
99.3	Investor Fact Sheet posted to the company website dated May 12, 2016

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 12, 2016          Chembio Diagnostics, Inc.

By:    /s/ John J. Sperzel III                                      

John J. Sperzel III

Chief Executive Officer

EXHIBIT INDEX

Exhibit Number	Description
99.1	Press Release entitled "Chembio Diagnostics Reports First Quarter 2016 Financial Results" dated May 12, 2016
99.2	Presentation entitled "Investor Presentation May 2016" dated  May 12, 2016
99.3	Investor Fact Sheet posted to the company website dated May 12, 2016

EX-99.1

Chembio Diagnostics Reports First Quarter 2016 Financial Results

Conference Call and Webcast Today at 10:00 a.m. Eastern Time

MEDFORD, NY, May 12, 2016 -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, today reported financial results for the three months ended March 31, 2016.

John J. Sperzel III, Chief Executive Officer, stated, "The first quarter of 2016 was exceptional for Chembio, with meaningful advancements in each of our business segments. In our sexually transmitted disease business, we achieved sales growth in North America, South America, Europe and Asia during the quarter, with a significant increase in U.S. sales.  In our fever disease business, driven by the serious threat posed by both Malaria and now by Zika virus, and through collaborations with leading health research and funding organizations, Chembio is working to leverage its patented DPP® technology into products that may allow healthcare workers to change current testing paradigms and contain the spread of life-threatening diseases.  During the period, we received a grant from the Paul G. Allen Family Foundation to initiate development of a DPP® Zika Assay.  Less than three months later, we announced our filing with Brazil's regulatory agency and plans to introduce the DPP® Zika IgM/IgG Assay in Brazil through our partner Bio-Manguinhos/Fiocruz, which is responsible for supplying diagnostics to Brazil's Ministry of Health.  And, in April, we received a grant from the Bill and Melinda Gates Foundation to complete feasibility on our DPP® technology platform, to develop the world's first POC Malaria assay using oral fluid/saliva. We are honored by the confidence of our partners in these endeavors and committed to delivering these much-needed POC diagnostic tools."

Addressing the company's financial results, Mr. Sperzel commented, "In the first quarter of 2016, Chembio's sexually transmitted disease product sales in North America, South America, Asia and Europe increased 29% as compared to the same quarter of the prior year.  Notably, in the U.S., we saw an increase in sales of approximately $1.0 million, an increase of approximately 78%, compared to the first quarter of 2015.  We are pleased with the demand for our HIV products in the U.S., and, as previously noted, effective June 1, 2016 we will begin selling the SURE CHECK® HIV 1/2 assay in the U.S. through our existing sales force and distribution channels.  Associated with the increase in sales, we've recorded an increase in accounts receivable of approximately $2.5 million as compared with the 1^st Quarter of 2015, resulting in total receivables of $4.9 million.  We are confident in our ability to collect these receivables, which will significantly increase our cash balance.  Though we saw a decrease in lateral flow product sales to Africa and South America during the first quarter, revenues for our DPP® products during the three months ended March 31, 2016 increased by approximately $195,000 over the same period in 2015, primarily due to increased sales in Brazil.  Chembio continues to have strong relationships with the Ministry of Health and Bio-Manguinhos/Fiocruz in Brazil, as evidenced by our recent fever disease collaboration, as well as other groups throughout Latin America, and we believe this region will continue to be a strong market for Chembio."

Selected Summary Financial Information comparing the 2016 first quarter to the 2015 first quarter:

• Total revenues of $6.60 million, compared with $6.23 million (an increase of 5.9%).

• Product sales of $5.92 million, compared with $5.61 million (an increase of 5.4%).

• Operating loss of $468,000, compared with operating loss of $875,000.

• Net loss of $304,000, or $0.03 per diluted share, compared with net loss of $647,000, or $0.07 per diluted share.

Additional Financial Information

First Quarter:

Total revenues for the first quarter of 2016 of $6.60 million increased 5.9% compared with total revenues of $6.23 million in the prior-year period. Product sales in the 2016 first quarter of $5.92 million increased 5.4% compared with product sales of $5.61 million in the prior-year period.  R&D milestone, and grant and royalty revenues for the three months ended March 31, 2016 increased to $662,000 from $609,000 in the prior-year period.

Gross margin dollars for the 2016 first quarter increased 17.8% to $3.17 million compared with $2.69 million for the prior-year period, due primarily to the mix in product revenues. The amount of product gross margin dollars for the first quarter of 2016 increased 19.9% to $2.48 million, from $2.07 million in the prior-year period.

R&D expenses in the first quarter of 2016 were $1.63 million, compared with $1.58 million in the prior-year period. This increase is due primarily to increased R&D activities for projects and grants.  Some projects are on a milestone basis for which revenue cannot be recognized until the milestone is achieved, while expenses to reach that milestone are expensed in the period incurred.

Selling, general and administrative expenses in the first quarter of 2016 increased to $2.00 million from $1.98 million in the prior-year period, largely due to increased professional fees, investor relations expenses and consulting partially offset by decreased wages and related expenses, commissions and stock-based compensation.

Operating loss for the first quarter of 2016 was $468,000, compared with an operating loss of $875,000 for the prior-year period.

Net loss for the first quarter of 2016 was $304,000, or $0.03 per diluted share, compared with net loss of $647,000, or $0.07 per diluted share, for the prior-year period.

Balance Sheet Highlights:

The Company had cash and cash equivalents of $2.66 million as of March 31, 2016, compared with $5.38 million as of December 31, 2015. The decrease was primarily due to net cash used in operating activities of $2.69 million. Our working capital decreased by $193,000 during the year from $9.48 million to $9.29 million.

Conference Call

To participate on the conference call on May 12, 2016 at 10:00 a.m. Eastern Time, 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 19, 2016 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 conference ID #: 13636711.  Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Chembio's website at www.chembio.com.  The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=175001. 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 $8.0 billion point-of-care testing market. Chembio markets its DPP^® HIV 1/2 Assay and HIV 1/2 STAT-PAK® Assay in the U.S. and internationally. The Company's SURE CHECK^® HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview^® Complete by a single entity. Outside the U.S., Chembio markets its SURE CHECK^® HIV 1/2 Assay primarily through distributors.

Chembio has developed a patented point-of-care (POC) 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.

Headquartered in Medford, NY, 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 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. 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.

(Tables to follow)

Contacts:

Chembio Diagnostics

Susan Norcott

(631) 924-1135, ext. 125

snorcott@chembio.com

Vida Strategic Partners (investor relations)

Stephanie C. Diaz

(415) 675-7401

sdiaz@vidasp.com

        

       

EX-99.2

Investor Presentation May 12, 2016

NASDAQ:CEMI

Rapid Tests for Earlier Treatment™™

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 Highlights

§ A global leader in point-of-care (POC) infectious disease

– Sales in 40+ countries, including United States

§ Revenue growth

– 8% CAGR over last five years (2010-2015)

§ Groundbreaking patented DPP^® technology platform

– Superior sensitivity and specificity vs lateral flow technology

– Multiple tests from a single oral fluid or blood sample (multiplexing)

§ Robust pipeline of new DPP^® POC assays in development

– DPP^® HIV-Syphilis Combination Assay (U.S. version)

– DPP^® Fever Assays (Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg)

– DPP^® Technology Collaboration (Traumatic Brain Injury, Cancer and Micro Reader)

§ Multiple high-value collaborations

– Paul G. Allen Ebola Program: Fever Panel, Zika

– Bill & Melinda Gates Foundation: Malaria Oral Fluid/Saliva

– Centers for Disease Control & Prevention (CDC): Malaria, Ebola, Flu Immunostatus

Slide 4

Chembio's Dual Path Platform (DPP^®) Technology Next-Generation Point-of-Care Technology Platform

§ Patented POC technology platform

§ Improved sensitivity vs. lateral flow technology

§ Multiple test results from a single patient sample

§ Adapts to multiple sample types (blood, oral fluid)

§ Application across a range of diseases and markets

§ Unique sample collection device: Sampletainer^®

See graphics

Slide 5

Chembio's Dual Path Platform (DPP^®) Technology

Leveraging Our Technology Platform to Enter New Markets

Three areas of Strategic Focus:

· STD Business

· Fever Portfolio

· Technology Collaborations

DPP® Technology Platform

Slide 6

HIV Continues to be a Global Health Crisis Syphilis and HIV-Syphilis Co-Infection are Increasing

United States (HIV)

· ~ 1.2 million living with HIV/AIDS

· ~ 50,000 new HIV infections/year

· 1 in 8 unaware of HIV infection

Global (HIV)

· 35.2 million living with HIV/AIDS (2012)

· 1.6 million died of AIDS-related illnesses (2012)

United States (SYP)

· ~56,000 new infections (2013)

Global (SYP)

· 12 million new infections/year

"Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable."  -CDC

"About 30% of pregnant women with syphilis will give birth to a dead baby (stillbirth), and another 30% to a live baby with congenital syphilis, a condition with a mortality of up to 50%"  -WHO

Slide 7

Product Portfolio: Sexually Transmitted Diseases

· DPP® HIV-Syphilis Combination

· DPP® HIV 1/2 Blood or Oral Fluid

· HIV 1/2 STAT-PAK®

· SURE CHECK® HIV 1/2

See graphics

Slide 8

Chembio Lateral Flow HIV Tests,  Foundational HIV Product Suite

Product Features & Benefits

· FDA (PMA) approved, CLIA-waived

· CE marked, WHO pre-qualified

· 2.5 - 5.0 μL blood sample

· 15 - 20 minute test time

· Specificity: 99.9%, Sensitivity: 99.7%

Commercialization

· High quality brands, marketed globally since 2007

· Sold to Public Health Clinics, POLs, Hospitals, Self Test (EU)

· Certain Distribution Partners (US): Fisher, McKesson/PSS, H. Schein, Medline

See graphics

Slide 9

Chembio DPP^® HIV and DPP^® HIV-SYP Combo Tests Addressing a Significant and Growing Need

§ DPP^® HIV-Syphilis Combo Assay

– First to market with POC HIV-Syphilis combo assay

– First to receive USAID and ANVISA (Brazil) approval

– Successfully launched in Mexico

– Global screening opportunity:

– Pregnant women

– MSM (up to 70% HIV-Syphilis co-infection)

– Establishing US clinical trials for FDA approval and CLIA Waiver

· DPP^® HIV 1/2 Assay

– FDA-approved and CLIA-waived  (blood and oral fluid)

– Superior performance (sensitivity) vs. competitors

– Patented SampleTainer® Sample Collection System

– U.S. Launch – Q4 2014

See graphics

Slide 10

DPP^® STD - Product Development Strengthening our STD Portfolio: HIV & Syphilis

§ DPP^® HIV-Syphilis Assay (being tested in U.S. market)

– Next Generation DPP^® HIV-Syphilis Combo Assay for detection of HIV and Syphilis antibodies

– US Clinical trials initiated Q1 2016

See graphics

Slide 11

Chembio's Dual Path Platform (DPP^®) Technology Leveraging Our Technology Platform to Enter New Markets

Three areas of Strategic Focus:

· STD Business

· Fever Portfolio

· Technology Collaborations

DPP® Technology Platform

Slide 12

Fever Diseases - A Growing Global Concern Malaria, Dengue Fever, Ebola

Malaria

· ~214 million infections/year(2015)

· ~438,000 deaths/year (2015)

Zika

· >40 Countries with active Zika virus transmission

Dengue Fever

· ~400 million infections/year (2015)

· 40% of world population at risk from Dengue (2015)

Ebola

· ~28,000 infections (2014-2015)

· ~11,000 deaths (2014-2015)

"Early diagnosis and treatment of malaria reduces disease and prevents deaths. It also contributes to reducing malaria transmission. WHO recommends that all cases of suspected malaria be confirmed using parasite-based diagnostic testing (either microscopy or rapid diagnostic test) before administering treatment" -WHO

Slide 13

DPP^® Fever - Product Development Partnering with World Leading Organizations

DPP® Fever Panel

Collaborator: Paul G. Allen Ebola Program

DPP® Zika Assay

Collaborator: Paul G. Allen Family Foundation

DPP® Malaria Assay

Chembio Internal Development

DPP® Dengue Assay

Collaborator: Undisclosed

DPP® Malaria-Ebola Assay

Collaborator: CDC

DPP® Chikungunya Assay

Chembio Internal Development

DPP® Malaria OF/Saliva Assay

Collaborator: The Bill and Melinda Gates Foundation

DPP® Zika/Dengue/Chikungunya Assay

Collaborator: Paul G. Allen Family Foundation

DPP® Ebola Assay

Collaborator: CDC

Slide 14

Chembio's Dual Path Platform (DPP^®) Technology Leveraging Our Technology Platform to Enter New Markets

Three areas of Strategic Focus:

· STD Business

· Fever Portfolio

· Technology Collaborations

DPP® Technology Platform

Slide 15

Established DPP^® Technology Collaborations Building Both STD and Non-STD Businesses

opTricon (Germany)

· DPP® Micro Reader designed specifically to complement Chembio's patented DPP® technology

Bio-Rad Laboratories, Inc. (NYSE: BIO)

– DPP^® used for Bio-Rad's Geenius™ HIV 1/2 Confirmatory Assay

Oswaldo Cruz Foundation (Brazil)

– Five DPP^® Products Currently Being Sold to Ministry of Health in Brazil

RVR (Malaysia)

– License, Technical Transfer, Contract Manufacturing, Distribution (planned)

Slide 16

DPP^® Technology - Collaborations Focused on Specific Product Development Opportunities

DPP® Flu Immunostatus

Collaborator: Centers for Disease Control & Prevention (contractor)

DPP® Traumatic Brain Injury

Collaborator: Perseus Science Group LLC

DPP® Cancer (Specific Form)

Collaborator: Undisclosed

DPP® Hepatitis C

Collaborator: Seeking Partner

Slide 17

Manufacturing Capabilities

United States (Chembio)

§ High volume manufacturing capabilities

– 20MM+ tests annually

§ 60,000 sq. ft. leased facilities

– Medford, NY and Holbrook, NY

§ Robust quality management system

– Full compliance with regulatory requirements (FDA, USDA, WHO, ISO)

– Expertise in manufacturing scale up, process validation and cGMP

§ Number of employees: ~140

Malaysia (RVR)

§ Completed license and technology transfer

§ Completed contract manufacturing readiness: Q4 2015

§ Initiated distribution of Chembio's products into Malaysia

§ Initiated plan to manufacture certain Chembio-branded products

See graphics

Slide 18

Selected Financial Highlights

Years Ended (in 000's)

	March 31, 2016			March 31, 2015
Net Product Revenues	$	5,917		$	5,615
Total Revenues	$	6,601		$	6,231
Gross Margin	$	3,166		$	2,687
Loss from Operations	$	(468	)	$	(875	)
Net Loss	$	(304	)	$	(647	)
Cash  (as of end of period)	$	2,658		$	2,816

Slide 19

Executive Leadership Team

Executive:  John J. Sperzel III,   President &CEO

Joined Chembio: 2014

Previous Experience: 2011-2013, President and CEO of ITC.; 1987-2011 Axis-Shield, Bayer Diagnostics, Instrumentation Laboratory and Boehringer Mannheim

Executive:  Richard Larkin, CPA  Chief Financial Officer

Joined Chembio: 2003

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

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

Joined Chembio: 2012

Previous Experience: 2009-2012, Sr. VP Scientific & Laboratory Services of Pall Corporation; 1991-2009 Pall Corporation

Executive:  Javan Esfandiari, M.S.  Chief Science and Technology Officer

Joined Chembio:  2000

Previous Experience: 1997-2000, Co-founder of Sinovus Biotech AB (Sweden), acquired by Chembio in 2000; 1993-1997 R&D Director On-Site Biotech

Executive:  Thomas Ippolito, VP Regulatory & Clinical Affairs

Joined Chembio: 2005

Previous Experience: 2000-2005, VP Quality & Regulatory of Biospecific Technologies Corp.; 1984-2000 United Biomedical Inc., Analytab Products Inc. and Eastern Long Island Hospital

Executive:  Michael Steele, VP Sales, Marketing and Business Development

Joined Chembio: 2012

Previous Experience: 2008-2011, VP Business Development of SeraCare Life Sciences; 1992-2008 Corautus Genetics, Life Therapeutics and Serologicals, Inc.

Executive:  Paul Lambotte, Ph.D, VP Product Development

Joined Chembio: 2014

Previous Experience: 2009 – 2014, President of PLC Inc.; 2009 – 2012 Chief Science Officer of Axxin Pty Ltd.; 2000-2009, VP of R&D and Business Development of Quidel, Inc.

Slide 20

2015/2016 Milestones – Achieved

§ Received ANVISA approval for DPP^® HIV-Syphilis Assay

– Brazil; February 2015

§ Initiated field testing of DPP^® Ebola Assay in West Africa

– CDC; June 2015

§ Awarded Grant to Develop Multiplex Test for Fever Diseases

– Paul G. Allen Ebola Program; October 2015

§ Signed agreement to launch the DPP® Micro Reader

– opTricon; October 2015

§ Acquired full rights to SURE CHECK^® HIV 1/2 Assay

– SDS; signed January 2015 to be effective June 1, 2016

§ Awarded Grant to Develop DPP^® Zika Assay & DPP® Zika Combo Assay

– Paul G. Allen Family Foundation; February 2016

§ Entered into Copllaborations to Develop DPP® Dever Assays for Brazil, including Zika

– Bio-Manguinos/Fiocruz; March 2016

§ Awarded Grant to Develop DPP^® Malaria Oral Fluid/Saliva

– Bill & Melinda Gates Foundation; April 2016

Slide 21

Investment Highlights

§ A global leader in point-of-care (POC) infectious disease

– Sales in 40+ countries, including United States

§ Revenue growth

– 8% CAGR over last five years (2010-2015)

§ Groundbreaking patented DPP^® technology platform

– Superior sensitivity and specificity vs lateral flow technology

– Multiple tests from a single oral fluid or blood sample (multiplexing)

§ Robust pipeline of new DPP^® POC assays in development

– DPP^® HIV-Syphilis Combination Assay (U.S. version)

– DPP^® Fever Assays (Malaria, Dengue , Zika, Chikungunya, Ebola, Lassa, Marburg)

– DPP^® Technology Collaboration (Traumatic Brain Injury, Cancer Micro Reader)

§ Multiple high-value collaborations

– Paul G. Allen Ebola Program: Fever Panel, Zika

– Bill & Melinda Gates Foundation: Malaria Oral Fluid

– Centers for Disease Control & Prevention (CDC): Malaria, Ebola, Flu Immunostatus

EX-99.3

Corporate Fact Sheet

May 2016

STOCK INFORMATION (as of May 9, 2016)

Ticker:CEMI

Exchange:Nasdaq

Share Price:$7.35/share

Market Cap:$70.93 Million

CORPORATE HIGHLIGHTS

•  Global Provider of High Quality POC  Infectious Disease Assays

     •  Sales in 40+ countries, including U.S.

· Consistent Revenue Growth (5 Year 8% CAGR)

•  Patented DPP^® (Dual Path Platform)  Technology

     •  DPP® HIV 1/2 Assay for Blood/Oral Fluid

     •  Multiple products sold into Latin America and U.S.

· Future Pipeline of DPP^® POC Assays   (internal development)

     • DPP® HIV-Syphilis Combination Assay (U.S.)

     • DPP®Malaria Assay

· DPP® Chikungunya Assay

•  Ongoing Collaborations/Development Projects:

•  DPP® Malaria Assay (Oral Fluid/Saliva)

·     DPP® Zika Assay

·     DPP® Dengue Assay

·    DPP® Zika/Dengue/Chikungunya Assay

·     DPP® Fever Panel Assay

·    DPP® Malaria/Ebola Assay

·    DPP® Flu Immunostatus

·    DPP® Traumatic Brain Injury

·    DPP® Cancer (specific form)

·    DPP® Micro Reader

COMPANY SNAPSHOT

Chembio Diagnostics, Inc. (NASDAQ: CEMI) develops, manufactures, licenses and markets rapid diagnostic assays in the growing $8.0 billion point-of-care (POC) testing market.  In addition to its branded and proprietary HIV assays, which it sells in the U.S. and internationally, the Company has several ongoing collaborations for the development of diagnostic assays for Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg, flu immunostatus, brain injury and a specific form of cancer.

Dual Path Platform (DPP^®) is Chembio's patented POC technology, which offers significant advantages over lateral-flow technologies, including enhanced sensitivity and the ability to conduct multiple tests from a single sample (multiplexing).  DPP^® continues to  provide Chembio with a growing pipeline of business opportunities for the development and manufacture of new products.

CHEMBIO'S LEAD PRODUCTS

DPP® HIV-Syphilis Assay*available in selected markets

o Rapid, multiplex detection of HIV 1, HIV 2 and syphilis using a single sample

DPP® HIV 1/2 Assay

o Rapid detection of HIV 1 and HIV 2 antibodies in oral fluid and all blood matrices

HIV 1/2 STAT-PAK® Assay

o Single-use, rapid, visual detection of HIV 1 and HIV 2 antibodies

SURE CHECK® HIV 1/2 Assay

o Self-contained, single-use collection & testing device

(See graphics)

PAGE 2

CHEMBIO'S DPP® DUAL PATH PLATFORM

o Patented technology

o Allows improved sensitivity and specificity compared to lateral flow technology

o Enables multiple test results via a single blood sample (e.g., HIV-Syphilis Combo Assay)

o Offers application within infectious disease and potential for a number of other indications

(See graphics)

Sexually Transmitted Diseases

HIV

o 35 million people living with HIV/AIDS worldwide (2013)

o More than 1.1 million people in the U.S. are living with HIV infection, and almost 1 in 8 (15.8%) are unaware of their infection

SYPHILIS

o Approx. 12 million people globally become ill with syphilis annually

o From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663

Fever Diseases

Malaria

· Approximately 214 million infections and 438,000 deaths annually (2015)

Dengue Fever

· Approximately 400 million infections annually with 40% of the world population at risk (2015)

Ebola

· Approximately 28,000 infections and 11,000 deaths in 2014 – 2015

Zika

· In February 2016,  WHO declared the Zika virus a "public health emergency of international concern," as the virus spread to more than 40 countries.

DPP PIPELINE & COLLABOTATORS

Chembio Internal Development:

o DPP® HIV-Syphilis Assay (testing in U.S. market)

o DPP® Malaria Assay

o DPP® Chikungunya Assay

Development Collaborations

•    DPP® Malaria Oral Fluid/Saliva- The Bill & Melinda Gates Foundation

· DPP® Zika- The Paul G. Allen Family Foundation

· DPP^®Dengue Fever – Undisclosed collaborator

•    DPP^®Zika/Dengue/Chikungunya- The Paul G. Allen Family Foundation

•    DPP^® Fever Panel – The Paul G. Allen Ebola Program

· DPP^® Malaria/Ebola & Dpp® Ebola Assays- CDC

· DPP^® Flu Immunostatus – CDC Contractor

•    DPP^® Traumatic Brain Injury – Perseus Science Group LLC

•    DPP^® Cancer (a specific form) – Undisclosed collaborator

Tech transfer and Distribution

o DPP^® technology for Geenius™ HIV 1/2 Confirmatory Assay – Bio Rad

o DPP® product distribution in Brazil- Oswaldo Cruz Foundation

o DPP® co-branding and distribution in Brazil- Labtest, Diagnostica SA

o DPP® tech transfer, manufacture and distribution in Malaysia- RVR

o DPP^® Micro Reader

CORPORATE OFFICERS

John J. Sperzel III, Chief Executive Officer

Richard Larkin, CPA, Chief Financial Officer

Sharon Klugewicz, M.S., Chief Operating Officer

Javan Esfandiari, M.S., Chief Science & Technology Officer

Chembio Diagnostics, Inc.	Investor Relations	Company Contact
3661 Horseblock Road	Vida Strategic Partners	Susan Norcott
Medford, NY 11763	Stephanie C. Diaz	631-924-1135 x125
Ph. 631-924-1135	(415) 675-7401	snorcott@chembio.com
Fax 631-924-2065	sdiaz@vidasp.com
www.chembio.com