HEMA DIAGNOSTIC SYSTEMS (HDS)

…DIAGNOSTIC SOLUTIONS FOR A CHANGING WORLD™…

Dr. Paul D SloweyExecutive Vice-President

Hema Diagnostic SystemsMay 2006

North Bay Village, Florida USA Saõ Paulo, Brazil Panama City, Panama

MISSION AND VISION STATEMENTSMISSION AND VISION STATEMENTS

Mission StatementMission Statement To provide the highest quality rapid diagnostic testing devices to To provide the highest quality rapid diagnostic testing devices to

the global market place in a cost effective mannerthe global market place in a cost effective manner

Vision StatementVision Statement To be recognized globally as a leading high quality developer and To be recognized globally as a leading high quality developer and

manufacturer of rapid diagnostic assaysmanufacturer of rapid diagnostic assays To respond to the needs of its customers by producing a To respond to the needs of its customers by producing a

continual pipeline of innovative point-of-care testscontinual pipeline of innovative point-of-care tests To be focused on customer satisfaction and innovate as market To be focused on customer satisfaction and innovate as market

forces dictateforces dictate

BRIEF HISTORY OF HDSBRIEF HISTORY OF HDS December, 2000: Founded as Hema Diagnostic Systems December, 2000: Founded as Hema Diagnostic Systems

(“HDS”) in Miami Beach Florida USA(“HDS”) in Miami Beach Florida USA July 2002: HDS Panama founded in Panama City, Panama for July 2002: HDS Panama founded in Panama City, Panama for

assembly/packagingassembly/packaging October 2003: Awarded patents for the Rapid 1-2-3® Hema EZ October 2003: Awarded patents for the Rapid 1-2-3® Hema EZ

technology platformtechnology platform January 2004: Licensed and subsequently acquired proprietary January 2004: Licensed and subsequently acquired proprietary

technology for tuberculosis from European Companytechnology for tuberculosis from European Company March 2004: Filed patents on the Rapid 1-2-3March 2004: Filed patents on the Rapid 1-2-3® Hema Express ® Hema Express

technology platformtechnology platform November 2004: Established new R&D facility (North Bay November 2004: Established new R&D facility (North Bay

Village, Florida)Village, Florida) November 2005: Opened new HDS branch office in SNovember 2005: Opened new HDS branch office in São Paulo, ão Paulo,

BrazilBrazil February 2006: Joined Global Business Coalition (GBC) February 2006: Joined Global Business Coalition (GBC)

SUMMARY OF HDS SUMMARY OF HDS PRODUCTS / SERVICESPRODUCTS / SERVICES

HDS offers high quality, reliable assays that address the global medical community’s need for simple, fast, and affordable rapid testing for infectious diseases including HIV/AIDS, tuberculosis, malaria, and others.

HDS offers unique proprietary and patented delivery systems incorporating high-quality test strips, manufactured under US GMP conditions, creating a system of rapid diagnostic assays unlike that of any other company.

RAPID TESTINGRAPID TESTING

WHAT IS RAPID TESTING? A rapid test is generally conducted in the field or clinic

setting, outside of a laboratory Tests are usually based on the principles of (lateral flow)

immunochromatography or hemaglutination Performed typically on, whole blood, urine or oral fluid Test results available in 10-20 minutes instead of days High degree of sensitivity/specificity Require limited training, simple to administer Require little or no equipment

HDS RAPID TESTING

TECHNOLOGIES

Rapid 1-2-3® Hema immunoassays include individually color-coded tests for:

--HIV 1 / 2

--Tuberculosis (TB)

--Malaria (pf, pf/pv, pf/pv/p total) --Syphilis

COLOR CODED STRIP TECHNOLOGYCOLOR CODED STRIP TECHNOLOGY

Each HDS test strip is individually color-coded to Each HDS test strip is individually color-coded to help eliminate confusion, and to easily identify help eliminate confusion, and to easily identify the type of test in use.the type of test in use.

HIV= HIV= REDRED

TB= TB= YELLOWYELLOW

MALARIA= MALARIA= GREENGREEN

SYPHILIS=SYPHILIS= BROWNBROWN

HEPATITIS=HEPATITIS= BLUEBLUE

PACKAGINGPACKAGING

Color coding on (foil) packagingColor coding on (foil) packaging

matches color coding ofmatches color coding of

test strips in the varioustest strips in the various

product formatsproduct formats

HDS HDS RAPID TESTING PLATFORMS

HDS Rapid Testing platforms include:

RAPID 1-2-3® HEMA EXPRESS™ RAPID 1-2-3® HEMA EZ™ RAPID 1-2-3® HEMA DIPSTICK STRIPS

RAPID 1-2-3® HEMA

EXPRESS™

Designed specifically for Designed specifically for application in developing application in developing nations.nations.

Whole blood, serum or Whole blood, serum or plasma specimens plasma specimens

Room temperature storageRoom temperature storage Long shelf lifeLong shelf life SafeSafe

RAPID 1-2-3® HEMA EXPRESS™

The The EXPRESSEXPRESS® ® device device is an easy-to-use, accurate, low is an easy-to-use, accurate, low cost, rapid testing platform with a small sample cost, rapid testing platform with a small sample requirement (10-30 requirement (10-30 μμL, fingerstick blood)L, fingerstick blood). .

All components are safe and simple to handle.All components are safe and simple to handle.

HOW IT WORKS: Remove protective Remove protective

cover from cover from EXPRESS EXPRESS ®

device, exposing thedevice, exposing the

sample pad.sample pad.

RAPID 1-2-3® HEMA EXPRESS™

Prick finger using safety Prick finger using safety lancetlancet

Touch sample pad to Touch sample pad to drop of blooddrop of blood

RAPID 1-2-3® HEMA EXPRESS™

The sample pad will absorb blood sample. Sample The sample pad will absorb blood sample. Sample should flow to between the patent pending design that should flow to between the patent pending design that incorporates “Minimum” and “Maximum” fill lines.incorporates “Minimum” and “Maximum” fill lines.

RAPID 1-2-3® HEMA EXPRESS™

Insert the assay into Insert the assay into the diluent tube.the diluent tube.

Blood and diluent Blood and diluent flow onto strip.flow onto strip.

RAPID 1-2-3® HEMA EXPRESS™

Within a few Within a few minutes a minutes a Control line Control line appears appears indicating the indicating the test is test is functioning functioning correctly.correctly.

RAPID 1-2-3® HEMA EXPRESS™

Read the Result at Read the Result at 15 minutes15 minutes

If the test If the test is negative, is negative, ONLY the the Control Control line (C) line (C) will appear. will appear.

RAPID 1-2-3® HEMA EXPRESS™

If the test isIf the test is

positive, thenpositive, then

BOTH the the

Control line (C)Control line (C)

and the Test line (T)and the Test line (T)

will appearwill appear

RAPID 1-2-3® HEMA EZ ® PLATFORM

Designed to meet the requirements of the Global market, Designed to meet the requirements of the Global market, including the United States, EU and Japanincluding the United States, EU and Japan

A simple and reproducible method of testing in point of A simple and reproducible method of testing in point of care situations such as doctors offices, mobile clinics, care situations such as doctors offices, mobile clinics, outpatient centersoutpatient centers

Currently being considered for over-the-counter use in a Currently being considered for over-the-counter use in a number of countries around the world.number of countries around the world.

The Rapid 1-2-3 HemaThe Rapid 1-2-3 Hema®® EZEZ®® device is a simple to use delivery device is a simple to use delivery platform that captures potentially platform that captures potentially infected blood within the housing.infected blood within the housing.

Sample pick-up is by a unique Sample pick-up is by a unique capillary, which holds (fingerstick) capillary, which holds (fingerstick) whole blood until it is ready to be whole blood until it is ready to be released on to the test strip.released on to the test strip.

RAPID 1-2-3® HEMA EZ ®

RAPID 1-2-3® HEMA EZ ®

HOW IT WORKS

Prick finger with safety lancetPrick finger with safety lancet

Touch the tip of the sampler to the Touch the tip of the sampler to the

drop of blood. Blood will drop of blood. Blood will

automatically be drawn up by automatically be drawn up by

capillary action into the sampler capillary action into the sampler

RAPID 1-2-3®HEMA EZ ®

Place sampler containing the blood collectedPlace sampler containing the blood collected

into the lower housinginto the lower housing..

RAPID 1-2-3® HEMA EZ ®

Push down on Push down on

the top of the the top of the

diluent filled poddiluent filled pod

Diluent in the pod and the Diluent in the pod and the blood in the sampler are blood in the sampler are released. released. Sampler Sampler and housing and housing are locked in are locked in place.place.

RAPID 1-2-3® HEMA EZ ®

Blood and Blood and diluent flow diluent flow down onto down onto the testthe test

strip.strip.

Within a few Within a few minutes a minutes a Control line Control line appears appears indicating indicating the test is the test is functioning functioning properly.properly.

Read Results Read Results

at 15 Minutesat 15 Minutes If the test is If the test is

negative, negative, ONLY the control the control line (C) line (C) will appear. will appear.

If the test is If the test is positive, positive, BOTH the control the control line (C) and line (C) and the test the test line (T) line (T) will appearwill appear

RAPID 1-2-3® HEMA EZ ®

HDS DIPSTICK FORMAT ASSAYS

Each assay consists of:Each assay consists of: Desiccated canister (containing 25, 50, or 100 Desiccated canister (containing 25, 50, or 100

test strips)test strips) Vial with diluent bufferVial with diluent buffer Safety lancetsSafety lancets Blood loopsBlood loops OEM packaging available (optional)OEM packaging available (optional) Sample trays (upon request)Sample trays (upon request)

HIV CLINICAL DATAHIV CLINICAL DATA

DIPSTICK AND EXPRESSDIPSTICK AND EXPRESS™™ DATADATA

Rapid 1-2-3Rapid 1-2-3® Hema HIV Performance ® Hema HIV Performance DataData

Strip Performance In one study a total of 1,470 negative (serum) specimens and 1,117 confirmed positive HIV specimens were tested alongside an FDA-approved

Abbott ELISA microplate assay.

Results:Results: (a) (a) Sensitivity Sensitivity

PositivesPositives

(+)(+)

NegativesNegatives

(-)(-)

TotalTotal

Rapid 1-2-3Rapid 1-2-3®®

Hema HIVHema HIV

1,1151,115 22 1,1171,117

Abbott HIV 1 / 2 Abbott HIV 1 / 2 ELISAELISA

1,1171,117 00 1,1171,117

Sensitivity = 1,115 / 1,117 x 100% = Sensitivity = 1,115 / 1,117 x 100% = 99.8%99.8%

Rapid 1-2-3Rapid 1-2-3® Hema HIV Performance ® Hema HIV Performance DataData

Strip Performance

(b) Specificity In order to test specificity 1,470 negative (serum) specimens were evaluated.

Results:Results:

PositivesPositives

(+)(+)

NegativesNegatives

(-)(-)

TotalTotal

Rapid 1-2-3Rapid 1-2-3®®

Hema HIVHema HIV

00 1,4701,470 1,4701,470

Abbott HIV 1 / 2 Abbott HIV 1 / 2 ELISAELISA

00 1,4701,470 1,4701,470

Specificity = 1,470 / 1,470 x 100% = Specificity = 1,470 / 1,470 x 100% = 100%100%

Rapid 1-2-3Rapid 1-2-3® Hema HIV Performance® Hema HIV Performance Data Data

Strip PerformanceStrip Performance In a second (non-clinical) study the performance of the Rapid 1-2-3In a second (non-clinical) study the performance of the Rapid 1-2-3® ®

Hema HIV Test was evaluated on 262 citrated whole blood specimens Hema HIV Test was evaluated on 262 citrated whole blood specimens from known HIV infected individuals. Detect™ HIV 1 / 2 ELISA (Adaltis, from known HIV infected individuals. Detect™ HIV 1 / 2 ELISA (Adaltis, Inc., Canada) was used as the “gold standard.”Inc., Canada) was used as the “gold standard.”

Results:Results: (a) (a) SensitivitySensitivity

PositivePositive

(+)(+)

NegativeNegative

(-)(-)

TotalTotal

Rapid 1-2-3Rapid 1-2-3®®

Hema HIVHema HIV

262262 00 262262

DetectDetect™™ HIV 1 / 2 HIV 1 / 2 262262 00 262262

Sensitivity = 262 / 262 x 100% = Sensitivity = 262 / 262 x 100% = 100%100%

Rapid 1-2-3Rapid 1-2-3® Hema HIV Performance Data® Hema HIV Performance Data

(b) Specificity(b) Specificity In order to assess specificity a total of 30 normal serum samples In order to assess specificity a total of 30 normal serum samples

(screened blood donors) were tested against the reference ELISA (screened blood donors) were tested against the reference ELISA assay (Detectassay (Detect™ HIV 1 /2, Adaltis, Inc.).™ HIV 1 /2, Adaltis, Inc.).

Results:Results:

PositivePositive

(+)(+)

NegativeNegative

(-)(-)

TotalTotal

Rapid 1-2-3Rapid 1-2-3®®

Hema HIVHema HIV

00 3030 3030

DetectDetect™™ HIV 1 / 2 HIV 1 / 2 00 3030 3030

Specificity = 30 / 30 x 100% = Specificity = 30 / 30 x 100% = 100%100%

100% Concordance with the reference ELISA assay.100% Concordance with the reference ELISA assay.

Rapid 1-2-3Rapid 1-2-3® Hema HIV ® Hema HIV Express™ Validation DataExpress™ Validation Data

(a) Sensitivity(a) Sensitivity Sensitivity characteristics of the Rapid 1-2-3Sensitivity characteristics of the Rapid 1-2-3®® Hema Express Hema Express™ ™

Platform were evaluated using a total of 192 positive sera confirmed by Platform were evaluated using a total of 192 positive sera confirmed by FDA-approved ELISA (Abbott HIV 1 / 2) and Western blot assays.FDA-approved ELISA (Abbott HIV 1 / 2) and Western blot assays.

Results:Results:

PositivePositive

(+)(+)

NegativeNegative

(-)(-)

TotalTotal

Rapid 1-2-3Rapid 1-2-3®®

Hema HIVHema HIV

192192 00 192192

Abbott HIV 1 / 2Abbott HIV 1 / 2 192192 00 192192

Sensitivity = 192 / 192 x 100% = Sensitivity = 192 / 192 x 100% = 100%100%

Rapid 1-2-3Rapid 1-2-3® Hema HIV ® Hema HIV Express™ Validation DataExpress™ Validation Data

(b) Specificity(b) Specificity Specificity characteristics of the Rapid 1-2-3Specificity characteristics of the Rapid 1-2-3®® Hema Express Hema Express™ ™

Platform were evaluated using a total of 300 negative sera from a Platform were evaluated using a total of 300 negative sera from a known (normal) blood donor population. Abbott HIV 1 / 2 ELISA was known (normal) blood donor population. Abbott HIV 1 / 2 ELISA was used as the “gold standard” methodology for comparisonused as the “gold standard” methodology for comparison

Results:Results: PositivePositive

(+)(+)

NegativeNegative

(-)(-)

TotalTotal

Rapid 1-2-3Rapid 1-2-3®®

Hema HIVHema HIV

00 300300 300300

Abbott HIV 1 / 2Abbott HIV 1 / 2 00 300300 300300

Specificity = 300 / 300 x 100% = Specificity = 300 / 300 x 100% = 100%100%

SUMMARY OF ADDITIONAL AVAILABLE DATASUMMARY OF ADDITIONAL AVAILABLE DATA

Interfering SubstancesInterfering Substances Low Titer Panels (BBI PRB 107)Low Titer Panels (BBI PRB 107) Anti HIV-1 Mixed Titer Panels (BBI PRB 202 / Anti HIV-1 Mixed Titer Panels (BBI PRB 202 /

PRB 203)PRB 203) Anti HIV-2 Performance Panel (BBI PRF 202)Anti HIV-2 Performance Panel (BBI PRF 202) Anti HIV 1 / 2 Combo Performance Panel (BBI Anti HIV 1 / 2 Combo Performance Panel (BBI

PRZ 204)PRZ 204) HIV-1 Seroconversion Panels (BBI PRB 959)HIV-1 Seroconversion Panels (BBI PRB 959) HIV Seroconversion Panels (NABI SV 400-403, HIV Seroconversion Panels (NABI SV 400-403,

SV 407-408)SV 407-408)

SUMMARY OF CLINICAL STUDIES AVAILABLE SUMMARY OF CLINICAL STUDIES AVAILABLE

Clinical studies performed at University College Hospital, Ibadan, Clinical studies performed at University College Hospital, Ibadan, NigeriaNigeria

Clinical studies performed at Mhu-Jhu Core Lab, New Mulago Clinical studies performed at Mhu-Jhu Core Lab, New Mulago Hospital, Kampala, UgandaHospital, Kampala, Uganda

Uganda National Blood Transfusion Service, Kampala Uganda Uganda National Blood Transfusion Service, Kampala Uganda studystudy

Data presented at the 10Data presented at the 10thth Conference on Retroviruses and Conference on Retroviruses and Opportunistic Infections, Boston USA 2003Opportunistic Infections, Boston USA 2003

National Institute of Communicable Diseases (NICD) study National Institute of Communicable Diseases (NICD) study (Johannesburg, South Africa)(Johannesburg, South Africa)

Instituto Commemorativo Gorgas de Estudios de la Salud Instituto Commemorativo Gorgas de Estudios de la Salud (GORGAS), Republic of Panama clinical study(GORGAS), Republic of Panama clinical study

Laboratorio Nacional de Salud Publica, Santo Domingo, Dominican Laboratorio Nacional de Salud Publica, Santo Domingo, Dominican Republic clinical studyRepublic clinical study

FEATURES / BENEFITSFEATURES / BENEFITS

Rapid 1-2-3Rapid 1-2-3® Hema HIV ® Hema HIV EEXPRESSXPRESS™™

FEATURES / BENEFITS (EXPRESSFEATURES / BENEFITS (EXPRESS™™ DEVICE) DEVICE)

FEATUREFEATURE BENEFITBENEFIT

Rapid delivery systemRapid delivery system Immediate resultsImmediate results

Fifteen (15) minute test (or less)Fifteen (15) minute test (or less) Results available at the “point-of-care”Results available at the “point-of-care”

Easy to useEasy to use Allows use by minimally trained usersAllows use by minimally trained users

SimpleSimple Reduces potential user errorReduces potential user error

Uses fingerstick whole bloodUses fingerstick whole blood Minimally invasive specimenMinimally invasive specimen

Cost effectiveCost effective Suitable for mass screening in less Suitable for mass screening in less developed nationsdeveloped nations

Safe, self contained unitSafe, self contained unit Minimizes exposure to potentially Minimizes exposure to potentially dangerous and infectious specimensdangerous and infectious specimens

Kits supplied with ALL components Kits supplied with ALL components necessary to perform the testnecessary to perform the test

No hidden costs or requirementsNo hidden costs or requirements

Color-coded disease specific kitsColor-coded disease specific kits Easy differentiation by customers in the Easy differentiation by customers in the fieldfield

FEATURES / BENEFITS (EXPRESSFEATURES / BENEFITS (EXPRESS™™ DEVICE) DEVICE)(Continued)(Continued)

FEATUREFEATURE BENEFITBENEFIT

Room temperature storageRoom temperature storage No refrigeration requirementsNo refrigeration requirements

Long shelf lifeLong shelf life Bulk procurement possible, saving Bulk procurement possible, saving valuable costs in purchase / shippingvaluable costs in purchase / shipping

Flexible packaging optionsFlexible packaging options Meets customer requirementsMeets customer requirements

Controls availableControls available External quality control possibleExternal quality control possible

Pictorial instructions (handbook sized Pictorial instructions (handbook sized training guide) availabletraining guide) available

Reduces potential user errorReduces potential user error

High quality manufacturing under US High quality manufacturing under US FDA GMP conditionsFDA GMP conditions

Lot-to-lot manufacturing consistency and Lot-to-lot manufacturing consistency and quality of productquality of product

Proprietary, patented platforms Proprietary, patented platforms Unique, differentiates HDS from Unique, differentiates HDS from competitorscompetitors

Assays may be used to test serum / Assays may be used to test serum / plasma samples plasma samples

Flexible, useful for validations using Flexible, useful for validations using characterized specimenscharacterized specimens

Proven in clinical testingProven in clinical testing Supporting clinical data available Supporting clinical data available

What makes HDS and its products unique and different?

Range of innovative, state-of-the-art assays/products Range of innovative, state-of-the-art assays/products supported by solid clinical datasupported by solid clinical data

Flexible packaging to meet varying market conditionsFlexible packaging to meet varying market conditions Simple/safe to administer, even by minimally trained Simple/safe to administer, even by minimally trained

personnel, in cases of staff shortagepersonnel, in cases of staff shortage Excellent order process/fulfillment recordExcellent order process/fulfillment record Backed by outstanding support from well-trained staffBacked by outstanding support from well-trained staff Affordable without sacrificing performanceAffordable without sacrificing performance Flexible financing for bulk volume purchasesFlexible financing for bulk volume purchases

At HDS, we want to make a difference in the fight against HIV / AIDS, malaria, TB and other infectious diseases

We listen to the needs of our Global customers, and build tools that can be used effectively in screening algorithms.

We do this with the knowledge that resources (facilities, manpower, financing) is not always available.

Consequently we develop high quality products at low cost

CONCLUSIONSCONCLUSIONS

At HDS, we will not sacrifice quality or reliability of a product for price.

Rather, we look for innovative ways to reduce costs and increase quality.

Thank you for your hospitality in inviting me to speak to you today and thanks for listening!!

……DIAGNOSTIC SOLUTIONS FOR A DIAGNOSTIC SOLUTIONS FOR A CHANGING WORLDCHANGING WORLDTMTM……

info@rapid123.com