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CEMI:OTCBB WWW.CHEMBIO. COM INVESTOR PRESENTATION AUGUST 2006

INVESTOR PRESENTATION AUGUST 2006

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INVESTOR PRESENTATION AUGUST 2006. Forward Looking Statements. - PowerPoint PPT Presentation

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Page 1: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

INVESTOR PRESENTATION

AUGUST 2006

Page 2: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

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 obtain additional financing 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. 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.

Page 3: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Investment Highlights

Growing Global Health Market For Rapid Tests

FDA Approval of Two HIV Tests Negotiating with US Marketing Partner

Successful Execution in International Markets

Pipeline of Complementary Products and Technologies

Experienced Management Team

Page 4: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

The US HIV Rapid Test Market is Growing

Estimated 30% of 1MM HIV+ in U.S. are not aware of their status Rapid tests provide the best chance to test and counsel at the point

of care and thereby reduce further transmission

Current market ~4MM ($50MM) tests could grow 4X New CDC recommendations for routine HIV testing for all

Americans age13- 64

$90MM additional funding requested by the President for 2006-2007 HHS Budget

Significant growth in hospital market

Additional future opportunity in the OTC market Guidelines for approval adopted by FDA, March 2006

Page 5: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

International Need for Several Hundred Million Tests 2007-2010

Estimated 40 million infected with HIV/AIDS worldwide, but only 10% aware of their status

Estimated 200MM tests needed for PEPFAR 2MM treatment goal

$8.3 billion spent on AIDS last year (half from US); UNAIDS estimates $22B / year needed by 2008

Annual therapy cost in 2001 - $10,000; ~$200 today More people will be tested with knowledge that treatment is available

Page 6: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Government Programs to Facilitate Awareness and Testing Initiatives

Clinton Foundation HIV/AIDS Initiative The initiative is focused on accelerating high quality treatment and partnering with industry to cost

effectively bring treatment to the people in need Chembio was one of four selected by the Clinton Foundation HIV/AIDS Initiative to make available

rapid HIV tests that will be used to detect HIV easily and cost effectively

The President's Emergency Plan for AIDS Relief (PEPFAR) Commitment to provide $15 billion over five years to fund the Emergency Plan for AIDS Relief The Plan will increase the availability of HIV testing services through a number of key innovative

strategies including ensuring adequate supplies of HIV test kits and other essential products

The Global Fund Created to finance a dramatic turn-around in the fight against AIDS, tuberculosis and malaria To date, the Global Fund has committed US$ 4.9 billion in 131 countries to support aggressive

interventions against AIDS, tuberculosis and malaria

Page 7: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Chembio’s Rapid HIV Tests

Rapid – 15 minutes

Safe, easy application

Operator friendly

Non–invasive whole blood sample – the standard

True IgG Control- Limits False Negatives

24 month shelf life

Highly sensitive (99.7%) and specific (99.9%)

Only closed rapid HIV system

FDA Approved 5/29/06

Page 8: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Chembio’s Rapid HIV Tests

FDA Approved 5/29/06WHO “Approved” 2005

Page 9: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

CEMI* OSUR** TRIB

FDA Approval Yes Yes Yes

No. of Rapid Test Formats 3 1 1Sensitivity 99.7% 99.6% 100.0%Specificity 99.9% 99.9% 99.7%Analyte(s) HIV 1&2 HIV 1&2 HIV 1Developing World Price $0.65 - $2.00 $3.50 $2.00

Successful International Collaborations

Brazil, Clinton, E. & W. Africa

OfficesNo No

US Price TBD $17.50 $15.75Strong US Marketing In Yes -Partner Negotiation AbbottTrue IgG Control Yes Yes NoShelf Life 24 mos. 6 mos. 12 mos.

* CLIA Waiver Application Not Submitted

HIV STAT-PAK Dipstick Product Not Submitted to FDA

** Orasure data are for whole blood; oral fluid sensitivity and specificity are lower

None

Page 10: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

HIV Tests Marketing Timeline

Q2 Q3 Q4 2007-2008

April 18, 2006: Chembio receives FDA approvable letter for its rapid HIV tests

May 29, 2006: Chembio receives FDA Approval for its rapid HIV tests

Q2: Expect CLAI Waiver submission

Early 2008: Commence Sales in Europe/OTC

Q4: Begin working on CE Marking

Q4: Commence Plan/Studies for OTC market

Q3: Expect to be granted CLIA Waiver

Q3/Q4: Anticipated Definitive Agreement with Marketing Partner for US and Other Markets (Professional & OTC)

Q3/Q4: Initial Sales US Market

2007-2008: Continue increases in US and international sales

Page 11: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

U.S. Marketing Plan

Currently in discussion with a partner to market HIV products in the U.S.

Will retain the right to market non-HIV products in the U.S.

Chembio will retain the marketing rights to all products outside the U.S.

Established Business Development Offices in Tanzania and Nigeria

Chembio’s test designated in Ugandan and Nigerian national protocols; several others pending; distributors established

13 Year technology transfer and supply contract with Brazilian government

Public-Private partnership

Marketing Strategy

Page 12: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

15,000 SF FDA approved leased facility in Medford, NY

Total of 70 Employees

Includes all R&D, QA/QC and Technical Support Functions as well as Sales, Administrative and Production and Assembly Functions

Will Also Be USDA licensed

Capacity to produce 10MM units based upon one operating shift

Facility automated for strip production and lamination

Plan to Invest in Assembly Automation

Will accommodate current and future products

Facilities & Manufacturing Overview

Page 13: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Tuberculosis Rapid Tests Human TB Under Development with DPP™

World’s Most Deadly Infectious Disease NIH, WHO Grants and Collaborations

Veterinary TB Leverages Our Expertise In TB Serology $50MM Market for Cattle and Other Species - First Product

Currently Under USDA Review for Approval

“Neglected” Diseases Chagas Disease Leading Rapid Test

$1.2 MM Order from PAHO New Product Collaborations in Discussion with Partners

Other Product Opportunities

Page 14: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

“Dual Path Platform” (DPP™) For Next Generation Tests

Increase of 10-50X in analytical sensitivity vs. conventional lateral flow

Oral fluid tests more feasible due to sample delivery

Patent pending Outside current lateral flow IP, reduces IP costs Licensing strategy for non-core applications

Technology in Development

12345678

Dual Path Rapid Test Platform

Page 15: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

1. Add 5 l of serum/blood to the sample+buffer well (1).

2. Add 1 drop of buffer to the sample+buffer well (1).

3. Add four drops of the same buffer to the buffer well (2) when the colored lines disappear.

4. Read the results at 15 minutes

Negative result: one line Positive result: two linesor

12345678 12345678 12345678

12345678 12345678

DPP Single Parameter Test Procedure

Page 16: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Growing HIV & Chagas Revenues

Chembio Diagnostics, Inc. 2004 2005 6 mos. 2005 6 mos. 2006$(000s)

Net Sales 2,749 3,360 1,160 2,742 Total Revenues 3,306 3,941 1,638 2,875 Gross Profit 704 1,332 537 1,000

21% 34% 33% 35%

SG&A 2,299 3,265 1,285 2,631 R & D Expenses 1,509 1,365 762 744 Net Loss (3,099) (3,252) (1,495) (2,391) Net Loss Attributable to

StockholdersHIV Test Revenues 1,242 2,400 584 1,423 Chagas Test Revenues 71 69 36 942

Unaudited

(5,042) (6,769) (4,588) (3,275)

Page 17: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Capital Structure as of 6/30/06

AS OF 6/30/2006 TOTAL

COMMONHELD BY

MANAGEMENT

Common Shares 10,669,185 1,952,828

Convertible Preferred SharesSeries A 149.9 CONVERTIBLE INTO 7,496,052 1,972,494 Series B 113.9 CONVERTIBLE INTO 9,338,983 88,971

27,504,220 3,912,310 Avg Price

Options: 0.69$ 1,781,875 757,500 Warrants: 0.77$ 23,578,994 2,675,236

52,865,089 7,345,046

Page 18: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Experienced Senior Management Team

Name Position Years Experience

Lawrence Siebert Chairman, President 24

Richard Larkin CFO 25

Avi Pelossof Sales, Marketing & Bus. Dev. 19

Les Stutzman Marketing 25

Javan Esfandiari R&D 18

Rick Bruce Operations 28

Tom Ippolito Regulatory 20

Page 19: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Independent Directors / Advisory Board

Independent Board Members Expertise; Experience

Alan Carus, CPA Audit Chair; Former Senior Executive, NYSE Company, Former Partner, E&Y

Gary Meller MD, MBA Health Care Technology; Former CEO, Health Services Division, Humana Inc.

Gerald Eppner Esq. Securities Lawyer; Kaye Scholer

Advisory Board Members Expertise; Experience

Dr. James Koziarz HIV Diagnostics; Abbott Laboratories

Dr. Peter Andersen TB Diagnostics; Staten Serum Institut

Dr. Mariano Levin Chagas & Other Neglected Diseases

Allen Moore Public Policy, Global Health; Senate & Exec. Branch

Page 20: INVESTOR PRESENTATION AUGUST 2006

CEMI:OTCBB ● WWW.CHEMBIO. COM

Summary of Chembio

Growing Global Health Market For Rapid Tests

Successful Execution in International Markets

FDA Approval of Two HIV Tests Negotiating with US Marketing Partner

Pipeline of Complementary Products and Technologies

Experienced Management Team