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):  August 6, 2015 (August 6, 2015)

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 August 6, 2015, the Company issued a press release entitled "Chembio Diagnostics Reports Second Quarter 2015 Financial Results".   A copy of the press release is furnished herewith as Exhibit 99.1.

On August 6, 2015, the Company posted a PowerPoint Presentation to their website entitled "Investor Presentation August  2015."  A copy of the presentation is furnished herewith as Exhibit 99.2.

In addition, also on August 6, 2015, 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

Exhibits.

99.1	Press Release entitled "Chembio Diagnostics Reports Second Quarter 2015 Financial Results" dated August 6, 2015
99.2	Presentation entitled "Investor Presentation August  2015" dated August 6, 2015
99.3	Investor Fact Sheet posted to the company website dated August 6, 2015

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.

August 6, 2015                                               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 Second Quarter 2015 Financial Results" dated August 6, 2015
99.2	Presentation entitled "Investor Presentation August 2015" dated August 6, 2015
99.3	Investor Fact Sheet posted to the company website dated August 6, 2015

EX-99.1

Chembio Diagnostics Reports Second Quarter Financial Results

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

MEDFORD, NY, August 6, 2015 -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care diagnostic tests for infectious diseases, today reported financial results for the three and six months ended June 30, 2015.

John J. Sperzel III, Chief Executive Officer, stated,"During the second quarter of 2015, Chembio continued to make progress toward each of its operational goals. These advancements toward commercial, development and collaborative milestones have significantly shaped our strategy.  We categorize our activities into three distinct business areas:  sexually transmitted diseases; fever and tropical diseases; and licensing/partnerships.  Each of these businesses is driven by Chembio's proprietary DPP® technology."

Mr. Sperzel continued, "DPP^® is a unique POC technology platform that offers industry-leading sensitivity and specificity, and the ability to test simultaneously for multiple diseases, with a single patient sample.  DPP^® is the foundation of our ongoing work in sexually transmitted disease and our priority internal program – the DPP^® HIV-Syphilis Assay for the U.S. market.  DPP^® is the core asset that supports each of our fever disease partnerships and our lead project in this area – the DPP^® Fever Panel Assay.  And lastly, the broad applicability of DPP^® allows Chembio to capture significant value beyond our core business focus in areas such as traumatic brain injury and a specific form of cancer.  Chembio is aggressively pursuing each of these existing opportunities, and we remain committed to leveraging the DPP^® technology across every appropriate application to improve healthcare worldwide and create value for Chembio's stakeholders."

Addressing the company's financial results, Mr. Sperzel commented, "While revenues for the six months of 2015 were slightly behind 2014 numbers, direct sales in 2015 largely overcame 2014 revenue associated with the termination of our U.S. distributorship agreement and certain sales in Latin America.  We are very pleased that our internal operations excellence program helped achieve a 15% improvement in the product gross margin percentage as compared to the same period in 2014.  In addition, our R&D revenues of $996,000, although less than the $1,076,000 in 2014, were strong in light of the $750,000 milestone payment from RVR in early 2014."

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

• Total revenues of $6.72 million, compared with $7.42 million (a decrease of 9.5%).

• Product sales of $6.32 million, compared with $7.25 million (a decrease of 12.8%).

• Operating loss of $898,000, compared with operating loss of $233,000

• Net loss of $664,000, or $0.07 per diluted share, compared with net loss of $146,000, or $0.02 per diluted share.

Financial information comparing the first six months of 2015 to the first six months of 2014:

• Total revenues of $12.95 million, compared with $13.24 million (a decrease of 2.2%).

• Product sales of $11.94 million, compared with $12.15 million (a decrease of 1.8%).

• Operating loss of $1,773,000, compared with operating loss of $616,000

• Net loss of $1,311,000, or $0.14 per diluted share, compared with net loss of $371,000, or $0.04 per diluted share.

Additional Financial Information

Second Quarter:

Total revenues for the second quarter of 2015 of $6.72 million were down 9.5% compared with total revenues of $7.42 million in the prior-year period. Product sales in the 2015 second quarter of $6.32 million were down 12.8% compared with product sales of $7.25 million in the prior-year period.  R&D milestone, and grant and royalty revenues for the three months ended June 30, 2015 increased to $395,000 from $174,000 in the prior-year period.

Gross margin dollars for the 2015 second quarter increased 1.2% to $3.02 million compared with $2.98 million for the prior-year period, due primarily to the increase in non-product revenues. The amount of product gross margin for the second quarter of 2015 decreased 6.6% to $2.62 million, from $2.81 million in the prior-year period.

R&D expenses in the second quarter of 2015 were $1.76 million, compared with $1.27 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 second quarter of 2015 increased to $2.16 million from $1.95 million in the prior-year period, largely due to increased staffing, wages and related costs, increased travel expenses (related to our commercialization efforts) and professional fees.

Operating loss for the second quarter of 2015 was $898,000, compared with an operating loss of $233,000 for the prior-year period.

Net loss for the second quarter of 2015 was $664,000, or $0.07 per diluted share, compared with net loss of $146,000, or $0.02 per diluted share, for the prior-year period.

First Six Months:

Total revenues for the first six months of 2015 of $12.95 million were down 2.2% compared with total revenues of $13.24 million in the prior-year period. Product sales in the 2015 first six months of $11.94 million were down 1.8% compared with product sales of $12.15 million in the prior-year period.  R&D milestone, and grant and royalty revenues for the three months ended June 30, 2015 decreased to $1,011,000 from $1,083,000 in the prior-year period.

Gross margin dollars for the 2015 first six months increased 8.6% to $5.71 million compared with $5.26 million for the prior-year period, due primarily to the increase in gross margin percentage. The amount of product gross margin for the first six months of 2015 increased 12.5% to $4.69 million, from $4.17 million in the prior-year period.

R&D expenses in the first six months of 2015 were $3.34 million, compared with $2.47 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 six months of 2015 increased to $4.14 million from $3.40 million in the prior-year period, largely due to increased commissions on sales in Brazil, increased staffing, wages and related costs, increased travel expenses (related to our commercialization efforts) and professional fees.

Operating loss for the first six months of 2015 was $1,773,000, compared with an operating loss of $616,000 for the prior-year period.

Net loss for the first six months of 2015 was $1,311,000, or $0.14 per diluted share, compared with net loss of $371,000, or $0.04 per diluted share, for the prior-year period.

Balance Sheet Highlights:

The Company had cash and cash equivalents of $1.56 million as of June 30, 2015, compared with $4.61 million as of December 31, 2014. The decrease was primarily due to net cash used in operating activities of $2.17 million, as well as investing activities to fund the purchase of a license and deposits on and purchase of fixed assets of $.88 million. Our accounts receivable balance is nearly double our historical levels. However, we recently held face to face discussions with the customer representing the largest portion of these receivables and have a high degree of confidence that our receivables will return to normal historical levels by the end of the year.  Our working capital decreased by $1.57 million during the six months from $12.37 million to $10.80 million.

Conference Call

To participate on the conference call on August 6, 2015 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 August 13, 2015 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 #:13615689.  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=174221. 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 August 2015

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

Our Vision & Mission

We enable longer and healthier living through detection and monitoring of serious diseases.

Our mission is to be a leader in the development and commercialization of diagnostic solutions. We are dedicated to delivering high-quality products that provide ease of use, and rapid and accurate results at the point-of-care (POC). As a global company, we are committed to innovation and the highest quality standards.

Slide 4

Investment Highlights

• Global Provider of High Quality POC Infectious Disease Tests

- Sales in 43 countries

• Revenue Growth Averaged 15% Over Last Five Years

- From $16.70MM for FY 2010;  to $27.65MM  for FY 2014

• Patented DPP® (Dual Path Platform) Technology

- Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay

  (FDA-Approved, CLIA-Waived)

- DPP® Revenue Growth of 137% in 2014 as compared to 2013

• Future Pipeline of DPP® POC Assays

- DPP® HIV-Syphilis Combination Assay (US version)

- DPP® Fever Panel Assay (Malaria, Dengue Fever, Ebola)

• New Collaborations and Development Projects

- POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu Immunostatus,

 Brain Injury and a Specific Type of Cancer

Slide 5

Global POC Diagnostics Company

U.S.

• Revenue (FY '14):  $7.2MM or 28%

• Established U.S. Sales & Marketing (June '14)

• DPP® HIV 1/2 FDA Approved, CLIA-Waived

• Funded Research: CDC, DOD, NIH (2013)

EUROPE

• Achieved CE mark for SURE CHECK® HIV (July '13)

• Achieved CE mark for HIV STAT-PAK®, (March '14)

• Pending CE mark for DPP® HIV and DPP® HIV/Syphilis Assays

ASIA

• Established License, Technical Transfer, Contract Manufacturing, Distribution  Agreement (Feb. '14)

LATIN AMERICA

• Revenue (FY '14): $16.4MM or 63%

• Strong OEM Partnerships (e.g., FIOCRUZ, Labtest)

• Branded products sold to NGOs, private  distributors

• Achieved ANVISA approval in Brazil for DPP® HIV-Syphilis Assay

MERA (Middle East, Russia, Africa)

• Revenue (FY '14): $2.1MM or 8%

• Sales channel: NGO-direct & through distributors

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

Slide 6

POC In-Vitro Diagnostics (IVD) Total Global Market

Global Professional POC Market ($ million)

	2011 Sales	2016 Sales	CAGR
Glucose	1,530	1,640	1%
Infectious Disease	810	950	3%
Critical Care	725	875	4%
Cardiac Markers	500	650	5%
Hematology	430	500	3%
Coagulation/PT, ACT	400	450	2%
Fecal Occult Blood	295	450	9%
Cholesterol/Lipids	275	355	5%
Drugs of Abuse	265	270	0%
HbA1c	150	300	15%
Other*	150	190	n/a
Pregnancy	130	135	1%

*Source: Kalorama Worldwide Market for IVD Tests - July 2012

Slide 7

Chembio Market Opportunities

HIV Market

• 35 million people were living with HIV/AIDS worldwide in 2013

• 1.6 million people died of AIDS-related illnesses in 2012

• In total, ~75 million people have been infected with the HIV virus and ~36 million have died of HIV

HIV Prevalence (15-49 years), by WHO Region  (See graphics)

Syphilis Market

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

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

• Syphilis in pregnancy leads to ~305,000 fetal & neonatal deaths annually

New Cases of STIs, by WHO Region

(See graphics)  Source: World Health Organization (2012)

Slide 8

HIV In The U.S. - The Importance of Testing

• More than 1.1 million people in the United States are living with HIV infection, and almost 1 in 6 of them (15.8%) are unaware of their infection

• There are ~50,000 new infections per year in the U.S.

• For every HIV infection that is prevented, an estimated $355,000 is saved in the cost of providing lifetime HIV treatment

Source: Center for Disease Control & Prevention (CDC)

Slide 9

Chembio "Lateral Flow" POC Tests

· Two Lateral Flow POC HIV Tests

‐ Chembio HIV 1/2  STAT-PAK®

‐ Chembio SURE CHECK® HIV 1/2 ¹

• Key Product Features

‐ FDA (PMA)-Approved, CLIA-Waived

‐ Sensitivity: 99%

‐ CE Marked, WHO-Approved

• Lateral flow patent expired in February 2015

‐ Chembio's royalty payment obligation for use of lateral flow technology ended Feb 2015

¹ Sold in U.S. as Clearview Complete® HIV 1/2 , sold in Europe as Chembio Stat View®HIV 1/2

See graphics

Slide 10

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

· Patented technology

· Allows improved sensitivity and specificity compared to lateral flow technology

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

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

See graphics

Slide 11

DPP® Assays – Commercial Products

DPP® HIV 1/2 Assay

• U.S. FDA (PMA) approved, CLIA-Waived  for use with blood and oral fluid samples

• U.S. Launch- Q4 2014

• Entering the ~$35MM oral fluid Assay market

• Superior Performance (sensitivity) vs. competitors

• Patented SampleTainer®Sample Collection System

DPP® HIV-Syphilis Combo Assay

• First to market with POC HIV-Syphilis combo assay

• First HIV-Syphilis Assay to be USAID Approved

• First to receive ANVISA approval (Brazil)

• Organizing clinical trials for US FDA approval.

• Successfully launched in Mexico

• Global screening opportunities:

‐ Pregnant Women (Incidence 1.9MM)¹

‐ MSM (up to 70% HIV-Syphilis co-infection)²

¹World Health Organization (WHO);   ²Center for Disease Control & Prevention (CDC)

Slide 12

DPP® Internal Development Pipeline

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

o Next Generation DPP® HIV-Syphilis "Combo" Assay for detection of HIV and Syphilis Antibodies

· DPP® HIV AB/AG Assay

o Next Generation DPP® HIV for the detection of HIV Antibody and Antigen

Slide 13

DPP® Research Collaborations

· DPP® Malaria Assay

o Bill & Melinda Gates Foundation

· DPP® Dengue Fever (Multiplex Assay)

o Undisclosed Partner

· DPP® Ebola Multiple Assay

o Intergrated BioTherapeutics, Inc.

· DPP® Flu Immunostatus Assay (Multiplex Assay)

o Centers for Disease Control & Prevention (CDC) Contractor

· DPP® Traumatic Brain Injury Assay

o Perseus Science Group, LLC

· DPP® Cancer (Specific Form) Assay

o Undisclosed Partner

Slide 14

DPP® Technology Collaborations

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

‐ DPP® Technology Used for Bio-Rad Geenius™ HIV 1/2 Confirmatory Assay

• Oswaldo Cruz Foundation (Brazil)

‐ Five DPP® Products Currently Being Sold to NGO's and Private Distributors

• Centers for Disease Control & Prevention (CDC)

‐ Research Collaboration Agreement: DPP® Ebola and DPP® Febrile Illness

• LabTest (Brazil)

‐ Assembly, Distribution – DPP® Co-branded (2015 Product Registration)

• RVR (Malaysia)

‐ License, Technical Transfer, Contract Manufacturing, Distribution

• Other

‐ Additional Opportunities in Discussion/Development

Slide 15

Chembio Manufacturing Capabilities

• Leased facilities (~60,000 sq. ft.) in Medford and Holbrook, NY

• High Volume Manufacturing Capabilities (>15MM tests annually)

• Robust Quality Management System

‐ POC tests serve diverse, regulated market

‐ Audited routinely by FDA CDRH/CBER, WHO, USDA, ISO (LNE), and our partners

‐ Expertise in manufacturing scale-up, process validation and adherence to GMP (Good Manufacturing Processes)

              Approximately 162 total employees

Slide 16

Selected Financial Highlights

Three Months Ended (in 000's)	June 30, 2015			June 30, 2014
NET PRODUCT REVENUES	$	11,936		$	12,153
TOTAL REVENUES	$	12,947		$	13,236
GROSS MARGIN	$	5,706		$	5,255
LOSS FROM OPERATIONS	$	(1,773	)	$	(616	)
NET LOSS	$	(1,311	)	$	(371	)
CASH (as of end of period)	$	1,564		$	6,835

Note: Accounts receivable as of 6/30/14 was $5,423 compared to 6/30/15 of $8,868

Slide 17

2014 Milestones - Achieved

• Product Development/Regulatory

‐ Achieved CE Mark for HIV 1/2 STAT-PAK®: March 2014

‐ Received CLIA Waiver for DPP® HIV 1/2 : October 2014

‐ Entered development agreements for Dengue Fever and specific Cancer assay: Oct 2014

‐ Signed Agreement with CDC Contractor to Develop POC Influenza Immunity: Nov 2014

Corporate/Operations

‐ Finalized Agreement with RVR (Malaysia) to build position in Asia: Feb 2014

‐ Established U.S. Distribution/Warehouse facility in Holbrook, NY: May 2014

‐ Obtained Exclusive POC license for certain IBT Ebola reagents: October 2014

‐ Increased Manufacturing Footprint and Capacity in Medford, NY: Dec. 2014

Commercial / Sales & Marketing

‐ Terminated STAT-PAK® Distribution Agreement with U.S. Distributor: June 2014

‐ Established U.S. Sales & Marketing team ( DPP® HIV 1/2 , HIV 1/2 STAT-PAK®): June 2014

‐ Signed DPP® and STAT-PAK agreements with 3 leading U.S. distributors: Sept-Oct 2014

Slide 18

2015 Milestones- Achieved & Anticipated

• Product Development/Regulatory

‐ Entered into Agreement with Perseus to Develop DPP^® Brain Injury Assay:  January 2015

‐ Grant from Bill & Melinda Gates Foundation to Develop DPP^® Malaria: January 2015

‐ Achieved ANVISA Approval for DPP^® HIV-Syphilis Assay in Brazil:  February 2015

‐ Provided DPP^® Ebola Assay to CDC for Field Testing in West Africa: Q2 2015

‐ Initiate Clinical Trial for DPP HIV-Syphilis Assay (U.S.):anticipated Q4 2015

• Corporate/Operations

‐ Hired Paul Lambotte Ph.D. (VP, Product Development): December 2014

‐

• Commercial / Sales & Marketing

‐ Acquired Full Rights to SURE CHECK^® HIV 1/2 Assay, effective June 1, 2016:  January 2015

‐ Expand Chembio U.S. Commercialization Team: in progress during 2015

‐ Enter into Additional Distribution Agreements in the U.S. Market: in progress during 2015

‐ Launch DPP® HIV-Syphilis Assay in Brazil: anticipated Q4 2015

Slide 19

Executive Leadership Team

Executive:  John J. Sperzel III,   President &CEO

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

Joined:  2014

Executive:  Richard Larkin, CPA  Chief Financial Officer

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

Joined:  2003

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

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

Joined:  2012

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

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

Joined:  2000

Executive:  Thomas Ippolito, VP Regulatory & Clinical Affairs

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

Joined:  2005

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

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

Joined:  2012

Executive:  Paul Lambotte, Ph.D

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

Joined: 2014

Slide 20

Investment Highlights

• Global Provider of High Quality POC Infectious Disease Tests

‐ Sales in 43 countries

• Revenue Growth Averaged 15% Over Last Five Years

‐ From $16.70MM for FY 2010; to $27.65MM  for FY 2014

• Patented DPP® (Dual Path Platform) Technology

‐ Lead Product: DPP® Blood/Oral Fluid HIV 1/2 Assay (FDA-Approved, CLIA-Waived)

‐ DPP® Revenue Growth of 137% in 2014 as compared to 2013

• Future Pipeline of DPP® POC Assays

‐ DPP® HIV-Syphilis Combination Assay (US version)

‐ DPP® Fever Panel Assay (Malaria, Dengue Fever, Ebola)

• New Collaborations and Development Projects

‐ POC DPP® Assays for Malaria, Dengue Fever, Ebola, Febrile Illness, Flu Immunostatus, Brain Injury and a Specific Type of Cancer