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):  March 7, 2017 (March 7, 2017)

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 March 7, 2017, the Company issued a press release entitled "Chembio Diagnostics Reports 2016 Financial Results".   A copy of the press release is furnished herewith as Exhibit 99.1

On March 7, 2017, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation March, 2017."  A copy of the presentation is furnished herewith as Exhibit 99.2.

In addition, also on March 7, 2017, 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 2016  Financial Results" dated March 7, 2017
99.2	Presentation entitled "Investor Presentation March 2017" dated  March 7, 2017
99.3	Investor Fact Sheet posted to the company website dated March 7, 2017

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.

March 7, 2017          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 2016 Financial Results" dated March 7, 2017
99.2	Presentation entitled "Investor Presentation March, 2017" dated  March 7, 2017
99.3	Investor Fact Sheet posted to the company website dated March 7, 2017

EX-99.1

Exhibit 99.1

Chembio Diagnostics Reports 2016 Financial Results

Conference Call and Webcast Today at 4:30 p.m. Eastern Time

MEDFORD, NY, March 7, 2017 -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care ("POC") diagnostic tests for infectious diseases, today reported financial results for the year ended December 31, 2016.

John J. Sperzel III, Chief Executive Officer, stated, "During 2016, the Company made significant advances to diversify its product portfolio, build its global sales & marketing infrastructure, and expand its operational capabilities. To diversify its product portfolio, the Company is leveraging its patented DPP^® technology platform to strengthen its core sexually transmitted disease business, build a highly-differentiated fever and tropical disease business, and establish technology collaborations to enter new POC markets.

"The Company expects to complete the U.S. clinical trial for its DPP^® HIV-Syphilis Assay on schedule during Q1 2017, and the preliminary results are highly encouraging. We also advanced multiple fever and tropical disease assays, which we expect to make important future revenue contributions, including DPP^® Malaria Assay, DPP^® Zika Assay, DPP^® Dengue Assay, DPP^® Chikungunya Assay, DPP^® Zika/Dengue/Chikungunya Assay, and DPP^® Fever Panel Assay. These efforts were accelerated due to funding and collaboration from the U.S. Government (i.e., HHS/ASPR/BARDA, CDC), the Paul G. Allen Family Foundation, and the Bill & Melinda Gates Foundation.

"To build its first-ever global sales and marketing infrastructure, the Company expanded its sales team during Q4 2016 by appointing experienced senior commercial leaders and recruiting experienced sales executives to focus on key markets, such as the United States, Latin America, Africa and Asia Pacific. Following the termination of our previous U.S. distributor in May 2016, and the expansion of our global sales & marketing infrastructure, we are well-positioned to commercialize our new and existing products, strengthen and expand our global distribution channels, and provide local support to customers and commercial partners around the world. During Q4 2016, the Company won a two-year HIV contract with the state of Florida, which is expected to contribute revenue of approximately $1.5 million between 2017 and 2018. Subsequent to the end of 2016, the Company won a two-year HIV contract with another state, which is expected to contribute revenue of approximately $0.5 million between 2017 and 2018.

"To expand our operational capabilities, we contracted to acquire Malaysia-based RVR Diagnostics to increase manufacturing capacity, establish a presence in Southeast Asia, and provide important regulatory access to key markets. Subsequent to the end of 2016, we completed the acquisition of RVR Diagnostics, hired an experienced Vice President of Global Manufacturing Operations, and secured multiple tenders in Southeast Asia which are expected to contribute revenue of approximately $1.5 million during 2017."

Addressing the Company's financial results, Mr. Sperzel commented, "Despite reporting a decrease in product sales during 2016, we are seeing important quarter-over-quarter sales growth.  The 2016 decrease in product sales was primarily due to the previously disclosed loss of DPP^® HIV and DPP^® Syphilis product sales as a result of a tender offer in Brazil having been awarded to a competitor at an extremely low price point, as well as the impact of the Company's decision to separate from its previous SURE CHECK^® HIV 1/2 Assay distributor in the U.S. market.  Despite this decline, quarter-over-quarter analysis shows sales growth with total revenues for the fourth quarter of 2016 up 13.3% and product sales for the fourth quarter of 2016 up 29.2%, as compared to the third quarter of 2016.  In addition, total revenues for the fourth quarter of 2016 were up 30.0% and product sales for the fourth quarter of 2016 were up 59.1%, as compared to the second quarter of 2016.

"In the U.S., sales of the Company's POC HIV Assays showed positive trends.  During 2016, U.S. sales of the HIV 1/2 STAT-PAK^® Assay increased 34.7% as compared to 2015. We are also seeing very encouraging U.S. sales of the SURE CHECK^® HIV 1/2 Assay. During the fourth quarter of 2016, U.S. sales of the SURE CHECK^® HIV 1/2 Assay increased by approximately $516,000 or 230.5% as compared to the third quarter of 2016. This growth provides evidence that we are effectively rebuilding the U.S. HIV STAT-PAK^® and SURE CHECK^® HIV business, after we re-gained the U.S. distribution rights to these products in June 2014 and June 2016, respectively."

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

• Total revenues of $4.25 million, compared with $4.42 million.

• Product sales of $3.23 million, compared with $3.74 million.

• Operating loss of $2.57 million, compared with operating loss of $1.20 million.

• Net loss of $2.56 million, or $0.21 per diluted share, compared with net loss of $.65 million, or $0.07 per diluted share.

Selected Summary Financial Information comparing the year of 2016 to the year of 2015:

• Total revenues of $17.87 million, compared with $24.26 million.

• Product sales of $13.68 million, compared with $21.89 million.

• Operating loss of $7.57 million, compared with operating loss of $3.55 million.

• Net loss of $13.35 million, or $1.26 per diluted share, compared with net loss of $2.40 million, or $0.25 per diluted share. The 2016 Net Loss includes a $5.80 million non-cash income tax provision as a result of the Company decreasing its deferred tax asset and taking a full valuation allowance against its carry forward loss; and the Net Loss for 2015 period, which resulted in an increase in the Company's deferred tax asset, includes a non-cash income tax benefit of $1.16 million.

Additional Financial Information

Fourth Quarter:

Total revenues in the 2016 fourth quarter of $4.25 million decreased 3.8% compared with $4.42 million in the prior-year period. Product sales in the 2016 fourth quarter of $3.23 million decreased 13.7% compared with $3.74 million in the prior-year period.  R&D milestone, and grant and royalty revenues in the 2016 fourth quarter of $1.03 million increased 51.2% compared with $.68 million in the prior-year period.

Gross margin dollars in the 2016 fourth quarter of $1.75 million decreased 6.3% compared with $1.87 million in the prior-year period, due primarily to decreased product revenues. Product gross margin dollars in the 2016 fourth quarter of $0.73 million decreased 39.1% compared with $1.19 million in the prior-year period, which also was primarily due to the decreased product revenues.

R&D expenses in the 2016 fourth quarter of $2.16 million increased 47.5%, compared with $1.47 million in the prior-year period. This increase is due primarily to increased clinical trial expenses as well as R&D activities for projects and grants. 

Selling, general and administrative expenses in the 2016 fourth quarter of $2.16 million increased 34.8% compared with $1.61 million in the prior-year period, largely due to increases in wages and related costs, increased commissions, which were due to increased sales in Brazil, as well as increases in professional fees, which were partially offset by a decrease in stock-based compensation.

Operating loss in the 2016 fourth quarter was $2.57 million, compared with an operating loss of $1.20 million in the prior-year period.

Net loss in the 2016 fourth quarter was $2.56 million, or $0.21 per diluted share, compared with net loss of $.65 million, or $0.07 per diluted share, in the prior-year period. 

2016 Year:

Total revenues for the year of 2016 of $17.87 million decreased 26.3% compared with $24.26 million in the prior-year period. Product sales for the year of 2016 of $13.68 million decreased 37.5% compared with $21.89 million in the prior-year period.  R&D milestone, and grant and royalty revenues for the year of 2016 of $4.19 million increased 76.8% compared with $2.37 million in the prior-year period.

Gross margin dollars for the year of 2016 of $8.45 million decreased 19.4% compared with $10.49 million in the prior-year period, due primarily to the decrease in product sales. The amount of product gross margin for the year of 2016 of $4.26 million decreased 47.5% compared with $8.12 million in the prior-year period.

R&D expenses for the year of 2016 of $8.43 million increased 32.1%, compared with $6.38 million in the prior-year period. This increase is due primarily to increased R&D activities for projects and grants. 

Selling, general and administrative expenses for the year of 2016 of $7.60 million decreased 0.9%, compared with $7.66 million in the prior-year period, largely due to decreased commissions on sales in Brazil, decreased stock-based compensation, and consulting, which were partially offset by increases in wages and related costs, marketing materials, investor relations expenses and professional fees.

Operating loss for the year of 2016 was $7.57 million, compared with an operating loss of $3.55 million in the prior-year period.

Net loss for the year of 2016 was $13.35 million, or $1.26 per diluted share, compared with net loss of $2.40 million, or $0.25 per diluted share, in the prior-year period.  The net loss in the 2016 period includes a non-cash tax provision for the recording of a valuation allowance on the Company's deferred tax asset of $5.80 million.  Net Loss for 2015 period, which resulted in an increase in the Company's deferred tax asset, includes a non-cash income tax benefit of $1.16 million.

Balance Sheet Highlights:

The Company had cash and cash equivalents of $10.55 million as of December 31, 2016, compared with $5.38 million as of December 31, 2015. The increase was primarily due to net cash raised in the sale of common stock, partially offset by cash used in operating activities for the year of 2016. The Company's working capital increased by $5.23 million from $9.48 million as of December 31, 2015 to $14.71 million.

In August 2016, the Company sold 2,300,000 common shares for a total of $13.8 million, which after expenses resulted in approximately $12.5 million in net funds to the Company.

Conference Call

To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8566 from outside the U.S.  To listen live via the Internet, please visit the Investor Relations section of Chembio's website at www.chembio.com.

To listen to a replay of the call, which will be accessible until March 14, 2017 at 11:59 p.m. ET, please dial (877) 481-4010 from the U.S. or (919) 882-2331 from outside the U.S., and enter conference ID #:10255.  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 each of its DPP^® HIV 1/2 Assay, HIV 1/2 STAT-PAK^® Assay, and SURE CHECK^® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors.  The Company's SURE CHECK^® HIV 1/2 Assay previously has been exclusively sold in the U.S. as Clearview^® Complete HIV 1/2 Assay.

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 March 7, 2017

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 & marketing organization in U.S., Europe, Africa, APAC and LATAM

– Manufacturing operations in the U.S. (Medford, NY) and Southeast Asia (Malaysia)

§ Groundbreaking patented DPP^® technology platform

– Superior sensitivity and specificity vs. traditional lateral flow technology

– Multiple tests from a tiny (10μL) drop of fingertip blood (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 Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)

§ Multiple high-value collaborations

– U.S. Government:

• HHS/ASPR/BARDA: Zika (option: Zika/Dengue/Chikungunya);

• CDC: Malaria, Ebola, Zika, Zika/Dengue/Chikungunya

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

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

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

§ Multiplex capability - 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 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

United States (SYP)

· ~63,000 new infections (2014)

Global (HIV)

· ~36.7 million living with HIV/AIDS (2015)

· ~1.1 million died of AIDS-related illnesses (2015)

Global (SYP)

· ~12 million new infections/year

Source: Centers for Disease Control & Prevention (CDC) website; World Health Organization (WHO) website

Slide 7

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)

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

See graphics

Slide 8

Chembio DPP^® HIV and DPP^® HIV-SYP Combo Tests Strengthening our HIV/STD Portfolio

§ DPP^® HIV-Syphilis Combo Assay

– Chembio has a history of leadership

– First to receive USAID, ANVISA, Cofepris approval

– First to market/sell in Latin America

– Global screening opportunity:

– Pregnant women

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

– Initiated US clinical trials for FDA approval and CLIA Waiver (expected trials completionQ1 2017)

· DPP^® HIV 1/2 Assay

– FDA-approved (2013), CLIA-waived (2014)

                           (blood and oral fluid)

– Superior performance vs. competitors

                          (sensitivity)

– Patented SampleTainer® Sample Collection System

See graphics

Slide 9

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 10

Fever Disease – Product Development

Chembio is Collaborating with World Leading Organizations

– Bill & Melinda Gates foundation

– CDC - Center for Disease Control

– BARDA

– Fiocruz

– The Paul G. Allen Family Foundation

See graphics

Slide 11

DPP^® Fever Disease - Product Development Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg

DPP® Fever Panel: Collaborator: The Paul G. Allen Family Foundation (PGAFF)

DPP^® Malaria OF/Saliva Assay: Collaborator: The Bill & Melinda Gates Foundation

DPP^® Malaria-Ebola Assay: Collaborator: CDC

DPP^® Ebola Assay: Collaborator: CDC

DPP^® Zika Assay: Collaborators: HHS/BARDA & The Paul G. Allen Family Foundation

DPP^® Zika/Dengue/Chik Assay: Collaborator: HHS/BARDA

DPP^® Dengue Assay: Collaborator: RVR Diagnostics

DPP^® Chikungunya Assay: Chembio Internal Development

Slide 12

Fever Diseases - A Growing Global Concern

Malaria, Dengue, Zika, Chikungunya, Ebola, Lassa, Marburg

§ Mosquito-Borne Illnesses

– Mosquito à world's deadliest animal

– Responsible for 725,000 deaths/year

– Global geographic coverage

§ Established Fever Markets:

– Malaria: > 200 million annual infections

– Dengue: ~300 million annual infections

§ Emerging Fever Markets:

– Zika

– Chikungunya

– Ebola

– Lassa

– Marburg

§ What Crisis Will We Face Next?

See graphics

Slide 13

Chembio is Well-Positioned to Address Zika Virus

§ Local Zika Transmission

– 2015 (Brazil) à 2017 (~60 countries)

§ Who Needs to Be Tested

– Pregnant Women

– Travelers to/from Endemic Areas

– Others?

§ Molecular Tests Limitations

– Laboratory test, venous sample

– Detects acute infections only - not antibodies

– No immediate results

– High cost

§ Chembio Zika Test Advantage

– Convenience: POC Test; fingerstick sample

– Detects Antibodies (lgM/lgG)

– Time to Result: 15 minutes

– Low cost compared to MDX tests

Source: Centers for Disease Control & Prevention (CDC) website

See graphics

Slide 14

DPP^® Zika/Dengue/Chikungunya - Development Demonstrates Expertise, Efficiency and Dedication

§ DPP® Zika IgM/lgG Development/Commercialization Timeline

– Received PGAFF grant; initiated project DPP® Zika Project – 2/16

– Announced Zika collaboration with Bio-Manguinhos/Fiocruz (Brazil) – 3/16

– Completed testing of >1,000 samples (including 600 pregnant women) – 4/16

– Announced regulatory filings with FDA-EUA (US, PR), ANVISA (Brazil) – 5/16

– Announced regulatory filings with WHO-EUA, Cofepris (Mexico), CE mark – 7/16i

– Received CE mark (Europe, Caribbean)- 7/16

– Announced U.S. Government (HHS/BARDA) funding of up to $13.2 million – 8/16

– Awarded CDC Contract, DPP® Zika/Dengue/Chikungunya (Peru, India, Guatemala, Haiti)- 9/16

– Received ANVISA approval, DPP® Zika Assay –119/16

See graphics

Slide 15

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 16

Technology Collaborations:

Bio-Rad(NYSE:BIO) and opTricon (Berlin, Germany)

§ Bio-Rad Geenius™ System:   HIV-1 and HIV-2 Confirmation

– Multiplex DPP^® Assay

– Developed by Chembio

– Licensed by Bio-Rad

– Marketed/sold by Bio-Rad (ex-Brazil)

§ Chembio DPP^® Micro Reader: Quantitative Results & Data Mgmt.

– Improves DPP ^® Performance

– Provides quantitative results

– Standardizes result interpretation

– Data capture, storage, transmission

– Key features: Simple, palm-sized, easy-to-read, battery-operated, cost-effective

See graphics

Slide 17

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

Leveraging Our Technology Platform to Enter New Markets

§ DPP^® Cancer Assay

– Undisclosed Partner

– Biomarkers to Detect Specific Form of Cancer

– 10uL Blood Sample, 20 Minute Test

– Quantitative Result

– In Development Phase

§ DPP^® TBI/Concussion Assay

– Perseus Science Group, LLC

– Biomarker to Detect TBI/Concussion

– 10uL Blood Sample, 20 Minute Test

– Quantitative Result

– In Development Phase

· DPP^® BovineTB

o U.S. Department of Agriculture (USDA)

o Biomarker to detect bovine tuberculosis

o 20 minute test results

o In development phase

See graphics

Slide 18

Chembio's Global Commercial Organization Shift from Product Supply Model to Direct Sales Model

§ Regained control of U.S. HIV products (2014 – 2016)

– Terminated prior U.S. distribution agreements (HIV 1/2 STAT-PAK^® and SURE CHECK^® HIV 1/2)

§ Developed internal commercialization structure (2014 – 2016)

– Direct sales of DPP^® HIV 1/2, HIV 1/2 STAT-PAK^®, and SURE CHECK^® HIV 1/2 products in the U.S. market

§ Established geographic coverage model in U.S. (2014 – 2016)

– Established agreements with U.S. distributors (e.g., McKesson, H. Schein, Fisher, Medline)

§ Hired Experienced and Accomplished Leadership (Q4 2016)

– Robert Passas, Ph.D. – President, EMEA and APAC Regions

• Trinity Biotech; The Binding Site; Abbott, Quidel

– Sharon Klugewicz  - President, Americas Region

• Chembio COO; Pall Corporation

§ Hired international sales executives to build commercial channels in Latin America, Africa and Asia Pacific (Q4 2016 – Q1 2017)

Slide 19

Manufacturing Capabilities

Medford, NYKuala Lampur, Malaysia

o Acquired RVR Diagnostics (January 2017)

o RVR Diagnostics, a subsidiary of Chembio Diagnostics

o International base of operations and existing sales revenue

o Cost effective manufacturing operations, ISO 13485 certification

o Strategic location in Southeast Asia provides access to new markets

o Regulatory access in Southeast Asia market

Combined Manufacturing Operations

o High volume manufacturing capabilities; current capacity 25MM tests

o 65,000 sq. ft. leased facilities (Medford, NY and Malaysia)

o Robust quality management system (Medford, NY)

o Full compliance with regulatory requirements (i.e., FDA, USDA, WHO, ISO)

o Expertise in manufacturing scale up, process validation and cGMP

o Total number of employees: ~165

Slide 20

Selected Financial Highlights

Year  Ended (in 000's)

	December 31, 2016			December 31, , 2015
Net Product Revenues	$	13,680		$	21,887
Total Revenues	$	17,670		$	24,255
Gross Margin	$	8,451		$	10,487
Loss from Operations	$	(7,752	)	$	(3,554	)
Net Loss	$	(13,347	)*	$	(2,397	)
Cash (as of end of period)	$	10,554	**	$	5,377

* The net loss in the 2016 period includes a tax provision for the recording of a valuation allowance on the Company's deferred tax asset of $5,801,000.  This is a non-cash transaction.

**Company public offering of securities, closed August 3, 2016, increased cash balance by  $12.5MM.

Experienced 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:  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 of On-Site Biotech

Executive:  Sharon Klugewicz, M.S.  President, Americas Region

Joined Chembio: 2012

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

Executive:  Robert Passas, Ph.D., President, EMEA & APAC Regions

Joined Chembio:  2016

Previous Experience: 2015-2016, VP, Worldwide Marketing and International Sales at Trinity Biotech; 2011-2015 Commercial Director at The Binding Site; 1993-2011 Abbott, Trinity Biotech, Quidel

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:  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.

Executive:  David Gyorke, VP Manufacturing Operations

Joined Chembio: 2017

Previous Experience: 2011-2016, VP operations of Nanomix, 1983-2011, NeoVista, Farallon Medical, Inc., Cholestech Corporation, Bio-Rad

EX-99.3

Corporate Fact Sheet

March 2017

STOCK INFORMATION (as of March 3, 2017)

Ticker:CEMI

Exchange:Nasdaq

Share Price:$  5.90/share

Market Cap:$72.56 Million

CORPORATE HIGHLIGHTS

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

§ Sales in 40+ countries

§ Global commercialization organization servicing the U.S., Europe, Africa, Asia Pacific and Latin America

§ Operations and manufacturing in the U.S. and Southeast Asia

Groundbreaking patented DPP^® technology platform

§ Superior sensitivity and specificity vs. traditional lateral flow technology

§ Multiple tests from a tiny (10uL) drop of fingertip blood (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 Collaborations (Traumatic Brain Injury, Cancer, Bovine TB)

Multiple high-value collaborations

§ U.S. Government, HHS/ASPR/BARDA: Zika, Dengue, Chikungunya

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

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

§ Centers for Disease Control & Prevention (CDC): Malaria, Ebola

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 Fever, Zika, Ebola and other febrile illness, 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 non-U.S. 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

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CHEMBIO'S DPP® DUAL PATH PLATFORM

§ Patented technology

§ Allows improved sensitivity and specificity compared to lateral flow technology

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

§ Utilized with DPP® Micro Reader for semi-quantitive results

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

 (See graphics)

SALES AND MARKETING

§ Global commercialization organization

§ Internal sales and marketing infrastructure

§ Partnerships with leading distributors

§ Experienced and accomplished leadership

§ Strategic base of operations in Southeast Asia

§ Sales organization servicing the U.S., Europe, Africa, Asia Pacific and Latin America

MANUFACTURING AND OPERATIONS

§ Operations in Medford, New York and Malaysia

§ High volume manufacturing capabilities

§ Cost effective manufacturing facility in Malaysia

§ 65,000 sq. ft. leased facilities

§ Robust quality management system

§ Regulatory access in Southeast Asia

§ Total employees: ~165

Sexually Transmitted Diseases

HIV

o Approximately 37 million people living with HIV/AIDS worldwide (2015)

o More than 1.1 million people in the U.S. are living with HIV infection, and approximately  1 in 8 are unaware of their infection

SYPHILIS

o Approx. 12 million people globally become ill with syphilis annually (2015)

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 100 million infections annually with 40% of the world population at risk (2013)

Ebola

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

Zika

· Since 2015, the geographical range of Zika virus has expanded rapidly, with transmission reported in 60+ countries

DPP PIPELINE & COLLABOTATORS

Chembio Current Internal Development:

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

•  DPP^® Malaria Assay

•  DPP^® Chikungunya Assay

Current Development Collaborations:

•  DPP^®Dengue Fever – Undisclosed collaborator

•  DPP^®Ebola & Febrile Illness – CDC Research Agreement

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

•  DPP^® Malaria OF/Saliva– The Bill & Melina Gates Foundation

•  DPP^® Zika Assay – The Paul G. Allen Family Foundation & HHS/BARDA

•  DPP^® Zika/Dengue/Chikungunya Assay – HHS/BARDA (option)

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

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

•  DPP^® BovidTB Assay – U.S. Department of Agriculture

Tech Transfer and Distribution:

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

• DPP^® product distribution in Brazil – Oswaldo Cruz Foundation

• DPP^®co-branding and distribution in Brazil – Labtest Diagnostica SA

SENIOR EXECUTIVE OFFICERS

John J. Sperzel III, Chief Executive Officer

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

Richard Larkin, CPA, Chief Financial Officer

Sharon Klugewicz, M.S., President, America's Region

Robert Passas, Ph.D, President, EMEA & APAC Regions

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