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 8, 2016 (March 7, 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 March 7, 2016, the Company issued a press release entitled "Chembio to Collaborate with Bio-Manguinhos/Fiocruz to Develop Point-of-Care Zika Diagnostic Tests for Brazil". A copy of the press release is furnished herewith as Exhibit 99.1.

On March 8, 2016, the Company issued a press release entitled "Chembio Diagnostics Reports 2015 Financial Results". A copy of the press release is furnished herewith as Exhibit 99.2.

On March 8, 2016, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation March 2016." A copy of the presentation is furnished herewith as Exhibit 99.3.

In addition, also on March 8, 2016, the Company posted an Investor Fact Sheet to their website. A copy of the fact sheet is furnished herewith as Exhibit 99.4

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 Collaborate with Bio-Manguinhos/Fiocruz to Develop Point-of-Care Zika Diagnostic Tests for Brazil"
99.2	Press Release entitled "Chembio Diagnostics Reports 2015 Financial Results" dated March 8, 2016
99.3	Presentation entitled "Investor Presentation March 2016" dated March 8, 2016
99.4	Investor Fact Sheet posted to the company website dated March 8, 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.

March 8, 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 to Collaborate with Bio-Manguinhos/Fiocruz to Develop Point-of-Care Zika Diagnostic Tests for Brazil"
99.2	Press Release entitled "Chembio Diagnostics Reports 2015 Financial Results" dated March 8, 2016
99.3	Presentation entitled "Investor Presentation March 2016" dated March 8, 2016
99.4	Investor Fact Sheet posted to the company website dated March 8, 2016

Chembio to Collaborate with Bio-Manguinhos/Fiocruz to Develop

Point-of-Care Zika Diagnostic Tests for Brazil

MEDFORD, N.Y., March 7, 2016 -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced plans to collaborate with Bio-Manguinhos/Fiocruz for the development of POC Zika diagnostic tests for Brazil.

Bio-Manguinhos is the unit of the Oswaldo Cruz Foundation (Fiocruz) responsible for development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet the demands of Brazil's national public health system. Over the last 12 years, Chembio and Bio-Manguinhos have collaborated on a number of POC diagnostic tests, including HIV, Syphilis, and Leishmania.

As previously announced, under a $550,000 initial grant from the Paul G. Allen Family Foundation, Chembio will use its patented Dual Path Platform (DPP^®) technology for the development of a stand-alone POC assay to detect Zika virus, as well as a multiplex POC assay to simultaneously detect Zika, Dengue, and Chikungunya viruses. In addition, Chembio will add Zika to the POC DPP^® Fever Panel Assay that is currently under development through a separate grant from the Paul G. Allen Ebola Program.

Javan Esfandiari, Chief Science and Technology Officer of Chembio commented, "The patented design of Chembio's DPP^® technology, which allows separate detection of IgM and IgG antibodies, is ideally-suited for the development of point-of-care assays for Zika, Dengue and Chikungunya. We are currently testing the DPP^® Zika Assay, multiplex DPP^® Zika/Dengue/Chikungunya Assay, and DPP^® Micro Reader with clinical specimens from Brazil, Colombia, Dominican Republic, El Salvador, Malaysia and the United States. Preliminary testing results are highly encouraging and our ongoing collaborations with Bio-Manguinhos/Fiocruz and the global scientific community are extremely helpful as we move toward a rapid and affordable solution."

John Sperzel, Chembio's Chief Executive Officer, commented, "We are pleased to work with Bio-Manguinhos/Fiocruz toward a solution for detecting Zika virus and related febrile illnesses in Brazil. Since receiving an initial grant from the Paul G. Allen Family Foundation, we have developed prototype DPP^® Zika and DPP^® Zika/Dengue/Chikungunya Assays and we hope to receive additional funding to accelerate the development and testing. It is essential that government, industry, and regulatory agencies work together to address the global health emergencies posed by emerging diseases such as Zika virus."

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.

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

Chembio Diagnostics Reports 2015 Financial Results

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

MEDFORD, NY, March 8, 2016 -- 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, 2015.

John J. Sperzel III, Chief Executive Officer, stated, "During 2015, Chembio took important strategic steps to expand our patented DPP® technology to new markets. While the company continues to strengthen its sexually transmitted disease business, we are also building robust product pipelines in two new areas: fever disease and technology collaborations, and we have been very successful executing our strategy to obtain grant-based or partner-based funding for these projects. In the last year, our fever disease product portfolio has grown to include the following highly differentiated products:

·	The DPP^®Fever Panel Assay, which is funded by the Paul G. Allen Ebola Program, is a point-of-care (POC) test for the simultaneous detection of Malaria, Dengue Fever, Chikungunya, Zika, Ebola, Lassa and Marburg;

·	The DPP^® Malaria-Ebola and DPP^®Ebola Assays, which were developed through a research collaboration agreement with the Centers for Disease Control and Prevention (CDC), are currently being field tested in West Africa;

·	The DPP^®Dengue Fever Assays, which have been funded by an undisclosed entity, are currently being field tested in Asia;

·	The DPP^®Malaria Assay, which has been funded by The Bill and Melinda Gates Foundation, is 10-times more sensitive than the current world-leading POC malaria test; and,

·	The recently-announced DPP^®Zika Assay, which has received initial funding from the Paul G. Allen Family Foundation.

While sexually transmitted disease products will continue to make important contributions to our business, we believe our new fever disease portfolio and technology collaborations will pave the way for future growth."

Mr. Sperzel continued, "Our new DPP^®Zika Assay development showcases the exceptional versatility and broad applicability of our DPP^® technology. In February, the World Health Organization (WHO) declared the Zika virus a 'public health emergency of international concern,' and today the virus has spread to more than twenty countries. In response to the outbreak, we began exploring the feasibility of a POC DPP^® Zika Assay. We are fortunate that the Paul G. Allen Family Foundation, recognizing the urgency of the matter, moved swiftly to provide Chembio with a grant to support the initiation of the project. We are pleased to report that in a few short weeks, we have developed a prototype assay and are in discussions with a number of agencies, all of which are interested in supporting the rapid development of this critical product. While this program is in the early stages, we hope that success with the DPP^®Zika Assay, like our DPP^® Ebola Assay, will further demonstrate Chembio's ability to rapidly and effectively deploy our DPP^® technology to address the world's most serious health threats."

Addressing the company's financial results, Mr. Sperzel commented, "In the U.S. during 2015, Chembio recorded an increase in lateral flow HIV sales of approximately $440,000 and an increase of DPP^® sales of more than $1.0 million (primarily as a result of sales to the CDC for DPP^® Malaria-Ebola and DPP^®Ebola Assays) as compared to the respective U.S. sales in 2014. We are optimistic about the increasing demand for our products in the U.S. We will also have full control of SURE CHECK® HIV Assay, effective June 1, 2016, to add to our U.S. commercial efforts. In Latin America, we experienced a decline in sales in 2015 due primarily to a $3.5 million decrease in sales of DPP^® HIV-Syphilis Assay in Mexico, related to excess inventory from 2014, and a $2.1 million decrease in sales of DPP^® HIV Assay in Brazil. We expect that our recently announced DPP^® Zika Assay program will expand our sales in this region, and given our initial indications for 2016, we believe Latin America will continue to be a strong market for Chembio."

Mr. Sperzel concluded, "Lastly, I'd like to comment on Chembio's filings this morning. In addition to our 10-K, we made filings to renew our shareholder rights agreement as well as our shelf registration. Our shareholder rights agreement expired at the end of November 2015 and our shelf registration expired in January 2016. As a standard corporate policy, Chembio management takes steps to keep all such agreements and tools current, and our filings today should not be interpreted to signify anything other than prudent business practice."

Financial information comparing the full year of 2015 to the full year of 2014:

•	Total revenues of $24.26 million, compared with $27.65 million (a decrease of 12.3%).

•	Product sales of $21.89 million, compared with $25.95 million (a decrease of 15.7%).

•	Operating loss of $3.55 million, compared with operating loss of $1.55 million.

•	Net loss of $2.40 million, or $0.25 per diluted share, compared with net loss of $1.14 million, or $0.12 per diluted share.

Financial information comparing the 2015 fourth quarter to the 2014 fourth quarter:

•	Total revenues of $4.42 million, compared with $7.10 million (a decrease of 37.7%).

•	Product sales of $3.74 million, compared with $6.55 million (a decrease of 42.9%).

•	Operating loss of $1.20 million, compared with operating loss of $0.67 million.

•	Net loss of $.65 million, or $0.07 per diluted share, compared with net loss of $.50 million, or $0.05 per diluted share.

Additional Financial Information

For the Full Year:

Total revenues for the full year of 2015 of $24.26 million were down 12.3% compared with total revenues of $27.65 million in the prior-year period. Product sales in the 2015 full year of $21.89 million were down 15.7% compared with product sales of $25.95 million for 2014. R&D milestone, and grant and royalty revenues for the full year 2015 increased to $2.37 million from $1.70 million in 2014.

Gross margin dollars for the full year 2015 decreased 3.0% to $10.49 million compared with $10.81 million for 2014, due primarily to the decrease in product revenues. The amount of product gross margin for the full year of 2015 decreased 11.0% to $8.12 million, from $9.12 million in 2014.

R&D expenses for the full year of 2015 were $6.38 million, compared with $4.83 million in 2014. 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 for the full year of 2015 increased to $7.66 million from $7.53 million in 2014, largely due to increased staffing, wages and related costs, increased travel expenses (related to our commercialization efforts), and professional fees.

Operating loss for the full year of 2015 was $3.55 million, compared with an operating loss of $1.55 million for 2014.

Net loss for the full year of 2015 was $2.40 million, or $0.25 per diluted share, compared with net loss of $1.14 million, or $0.12 per diluted share, for 2014.

Fourth Quarter:

Total revenues for the fourth quarter of 2015 of $4.42 million were down 37.7% compared with total revenues of $7.10 million in the prior-year period. Product sales in the 2015 fourth quarter of $3.74 million were down 42.9% compared with product sales of $6.55 million in the prior-year period. R&D milestone, and grant and royalty revenues for the three months ended December 31, 2015 increased to $680,000 from $546,000 in the prior-year period.

Gross margin dollars for the 2015 fourth quarter decreased 35.7% to $1.87 million compared with $2.91 million for the prior-year period, due primarily to the decrease in product revenues. The amount of product gross margin dollars for the fourth quarter of 2015 decreased 49.6% to $1.19 million, from $2.36 million in the prior-year period.

R&D expenses in the fourth quarter of 2015 were $1.47 million, compared with $1.39 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 fourth quarter of 2015 decreased to $1.61 million from $2.19 million in the prior-year period, largely due to decreased commissions, stock-based compensation and marketing material expenses, partially offset by increases in consulting and professional fees.

Operating loss for the fourth quarter of 2015 was $1.20 million, compared with an operating loss of $0.67 million for the prior-year period.

Net loss for the fourth quarter of 2015 was $.65 million, or $0.07 per diluted share, compared with net loss of $0.50 million, or $0.05 per diluted share, for the prior-year period.

Balance Sheet Highlights:

The Company had cash and cash equivalents of $5.38 million as of December 31, 2015, compared with $4.61 million as of December 31, 2014. The increase was primarily due to net cash provided by operating activities of $1.79 million, partially offset by investing activities to fund the purchase of a license and deposits on and purchase of fixed assets of $1.03 million. Our working capital decreased by $3.22 million during the year from $12.37 million to $9.15 million.

Conference Call

To participate on the conference call on March 8, 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 March 15, 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 #: 13631215. 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=174739. An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com.

About Chembio Diagnostics

Forward-Looking Statements

(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

Investor Presentation March 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 DPP^® technology platform

–	Superior sensitivity and specificity vs lateral flow technology

–	Multiple tests from a single oral fluid or blood sample

§	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

–	Paul G. Allen Family Foundation: Zika

–	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) approved

–	Successfully launched in Mexico

–	Global screening opportunity:

•	Pregnant women

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

·	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 (U.S. market)

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

–	Expect clinical trials to begin Q1 2016

•	Number of patients: 1200

•	Duration: 6-9 months

•	Cost: $1.0 - $1.5MM

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

·	~198 million infections/year(2013)

·	~584,000 deaths/year (2013)

Zika ?

Dengue Fever

·	~100 million infections/year (2013)

·	40% of world population at risk from Dengue (2013)

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-Ebola

Collaborator: CDC

DPP® Dengue Fever

Collaborator: Undisclosed

DPP® Ebola

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: ~155

Malaysia (RVR)

§	Completed license and technology transfer

§	Completed contract manufacturing readiness: Q4 2015

§	Initiated distribution of Chembio's products into Malaysia

§	Plan to manufacture certain Chembio-branded products

See graphics

Slide 18

Selected Financial Highlights

Years Ended (in 000's)

	December 31, 2015			December 31, 2014
Net Product Revenues	$	21,887		$	25,950
Total Revenues	$	24,255		$	27,645
Gross Margin	$	10,487		$	10,814
Loss from Operations	$	(3,554	)	$	(1,550	)
Net Loss	$	(2,387	)	$	(1,137	)
Cash (as of end of period)	$	5,377		$	4,615

Note: took a full valuation allowance on our deferred tax asset resulting in the larger Net Loss over Loss from Operations

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

§	Signed agreement to develop DPP^® Brain Injury Assay

–	Perseus Science; January 2015

§	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

–	Paul G. Allen Family Foundation; February 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 DPP^® technology platform

–	Superior sensitivity and specificity vs lateral flow technology

–	Multiple tests from a single oral fluid or blood sample

§	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

–	Paul G. Allen Family Foundation: Zika

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

Corporate Fact Sheet

March 2016

STOCK INFORMATION (as of March 4, 2016)

Ticker: CEMI

Exchange: Nasdaq

Share Price: $5.54/share

Market Cap: $53.34Million

CORPORATE HIGHLIGHTS

• Global Provider of High Quality POC

Infectious Disease Assays

• Sales in 43 countries

• Patented DPP^® (Dual Path Platform)

Technology

• Multiple products sold into Latin America

and U.S.

• Lead Product: DPP^® HIV 1/2 Assay

for Blood/Oral Fluid

• FDA Approved & CLIA-Waived

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

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

• Malaria Assay

• Ongoing Collaborations and Development

Projects for:

• Dengue Fever

• Zika

• Ebola

• Febrile Illness

• Flu Immunostatus

• Brain Injury

• Cancer (specific form)

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, 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 select 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

o	Sold outside U.S. by Chembio

o	Sold in U.S. as Clearview® Complete

(See graphics)

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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 198 million infections and 584,000 deaths annually (2013)

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

·	In February 2016, WHO declared the Zika virus a "public health emergency of international concern," as the virus spread to more than 20 countries.

DPP PIPELINE & COLLABOTATORS

Chembio Internal Development:

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

o	DPP® HIV Ab/Ag Assay

Development Collaborations

• DPP^® Dengue Fever – Undisclosed collaborator

• DPP^® Ebola & Febrile Illness –CDC Contractor

• DPP^® Flu Immunostatus – CDC Contractor

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

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

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

• DPP^® Zika Assay – The Paul G. Allen Family Foundation

Tech transfer and Distribution

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

o	Distribution of 5 DPP® products in Brazil- Oswaldo Cruz Foundation

o	Research Agreement: DPP® Ebola and DPP® Febrile Illness – CDC Research Agreement

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