HEMA DIAGNOSTIC SYSTEMS (HDS)

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HEMA DIAGNOSTIC SYSTEMS (HDS)DIAGNOSTIC
SOLUTIONS FOR A CHANGING WORLDDr. Paul D
SloweyExecutive Vice-PresidentHema Diagnostic
SystemsMay 2006North Bay Village, Florida USA
Saõ Paulo, Brazil Panama
City, Panama
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MISSION AND VISION STATEMENTS

• Mission Statement
• To provide the highest quality rapid diagnostic
  testing devices to the global market place in a
  cost effective manner
• Vision Statement
• To be recognized globally as a leading high
  quality developer and manufacturer of rapid
  diagnostic assays
• To respond to the needs of its customers by
  producing a continual pipeline of innovative
  point-of-care tests
• To be focused on customer satisfaction and
  innovate as market forces dictate

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BRIEF HISTORY OF HDS

• December, 2000 Founded as Hema Diagnostic
  Systems (HDS) in Miami Beach Florida USA
• July 2002 HDS Panama founded in Panama City,
  Panama for assembly/packaging
• October 2003 Awarded patents for the Rapid
  1-2-3 Hema EZ technology platform
• January 2004 Licensed and subsequently acquired
  proprietary technology for tuberculosis from
  European Company
• March 2004 Filed patents on the Rapid 1-2-3
  Hema Express technology platform
• November 2004 Established new RD facility
  (North Bay Village, Florida)
• November 2005 Opened new HDS branch office in
  São Paulo, Brazil
• February 2006 Joined Global Business Coalition
  (GBC)

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SUMMARY OF HDS PRODUCTS / SERVICES
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HDS offers high quality, reliable assays
that address the global medical communitys need
for simple, fast, and affordable rapid testing
for infectious diseases including HIV/AIDS,
tuberculosis, malaria, and others.
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• 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.

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RAPID TESTING
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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

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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
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COLOR CODED STRIP TECHNOLOGY

• Each HDS test strip is individually color-coded
  to help eliminate confusion, and to easily
  identify the type of test in use.
• HIV RED
• TB YELLOW
• MALARIA GREEN
• SYPHILIS BROWN
• HEPATITIS BLUE

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PACKAGING

• Color coding on (foil) packaging
• matches color coding of
• test strips in the various
• product formats

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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

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RAPID 1-2-3 HEMA EXPRESS

• Designed specifically for application in
  developing nations.
• Whole blood, serum or plasma specimens
• Room temperature storage
• Long shelf life
• Safe

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RAPID 1-2-3 HEMA EXPRESS

• The EXPRESS device is an easy-to-use,
  accurate, low cost, rapid testing platform with a
  small sample requirement (10-30 µL, fingerstick
  blood).
• All components are safe and simple to handle.
• HOW IT WORKS
• Remove protective
  
• cover from EXPRESS
• device, exposing the
• sample pad.

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RAPID 1-2-3 HEMA EXPRESS

• Prick finger using safety lancet

• Touch sample pad to drop of blood

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RAPID 1-2-3 HEMA EXPRESS

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

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RAPID 1-2-3 HEMA EXPRESS

• Insert the assay into the diluent tube.

• Blood and diluent flow onto strip.

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RAPID 1-2-3 HEMA EXPRESS

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

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RAPID 1-2-3 HEMA EXPRESS

• Read the Result at 15 minutes
• If the test is negative,
  ONLY the Control
  line (C) will appear.

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RAPID 1-2-3 HEMA EXPRESS

• If the test is
• positive, then
• BOTH the
• Control line (C)
• and the Test line (T)
• will appear

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RAPID 1-2-3 HEMA EZ PLATFORM

• Designed to meet the requirements of the Global
  market, including the United States, EU and Japan
• A simple and reproducible method of testing in
  point of care situations such as doctors offices,
  mobile clinics, outpatient centers
• Currently being considered for over-the-counter
  use in a number of countries around the world.

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RAPID 1-2-3 HEMA EZ

• The Rapid 1-2-3 Hema EZ device is a simple to
  use delivery platform that captures potentially
  infected blood within the housing.
• Sample pick-up is by a unique capillary, which
  holds (fingerstick) whole blood until it is ready
  to be released on to the test strip.

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RAPID 1-2-3 HEMA EZ

• HOW IT WORKS
• Prick finger with safety lancet
• Touch the tip of the sampler to the drop of
  blood. Blood will automatically be drawn up by
  capillary action into the sampler

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RAPID 1-2-3HEMA EZ

• Place sampler containing the blood collected
• into the lower housing.

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RAPID 1-2-3 HEMA EZ

• Push down on
• the top of the
• diluent filled pod

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

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RAPID 1-2-3 HEMA EZ

• Blood and diluent flow
  down onto the test
• strip.

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

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RAPID 1-2-3 HEMA EZ

• Read Results
• at 15 Minutes
• If the test is negative, ONLY the
  control line (C)
  will appear.

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

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HDS DIPSTICK FORMAT ASSAYS

• Each assay consists of
• Desiccated canister (containing 25, 50, or 100
  test strips)
• Vial with diluent buffer
• Safety lancets
• Blood loops
• OEM packaging available (optional)
• Sample trays (upon request)

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HIV CLINICAL DATA

• DIPSTICK AND EXPRESS DATA

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Rapid 1-2-3 Hema HIV Performance Data

• 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 (a) Sensitivity

Positives () Negatives (-) Total
Rapid 1-2-3 Hema HIV 1,115 2 1,117
Abbott HIV 1 / 2 ELISA 1,117 0 1,117

• Sensitivity 1,115 / 1,117 x 100 99.8

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Rapid 1-2-3 Hema HIV Performance Data

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

Positives () Negatives (-) Total
Rapid 1-2-3 Hema HIV 0 1,470 1,470
Abbott HIV 1 / 2 ELISA 0 1,470 1,470

• Specificity 1,470 / 1,470 x 100 100

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Rapid 1-2-3 Hema HIV Performance Data

• Strip Performance
• In a second (non-clinical) study the performance
  of the Rapid 1-2-3 Hema HIV Test was evaluated
  on 262 citrated whole blood specimens from known
  HIV infected individuals. Detect HIV 1 / 2 ELISA
  (Adaltis, Inc., Canada) was used as the gold
  standard.
• Results (a) Sensitivity

Positive () Negative (-) Total
Rapid 1-2-3 Hema HIV 262 0 262
Detect HIV 1 / 2 262 0 262

• Sensitivity 262 / 262 x 100 100

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Rapid 1-2-3 Hema HIV Performance Data

• (b) Specificity
• In order to assess specificity a total of 30
  normal serum samples (screened blood donors) were
  tested against the reference ELISA assay (Detect
  HIV 1 /2, Adaltis, Inc.).
• Results

Positive () Negative (-) Total
Rapid 1-2-3 Hema HIV 0 30 30
Detect HIV 1 / 2 0 30 30
Specificity 30 / 30 x 100 100 100
Concordance with the reference ELISA assay.
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Rapid 1-2-3 Hema HIV Express Validation Data

• (a) Sensitivity
• Sensitivity characteristics of the Rapid 1-2-3
  Hema Express Platform were evaluated using a
  total of 192 positive sera confirmed by
  FDA-approved ELISA (Abbott HIV 1 / 2) and Western
  blot assays.
• Results

Positive () Negative (-) Total
Rapid 1-2-3 Hema HIV 192 0 192
Abbott HIV 1 / 2 192 0 192
Sensitivity 192 / 192 x 100 100
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Rapid 1-2-3 Hema HIV Express Validation Data

• (b) Specificity
• Specificity characteristics of the Rapid 1-2-3
  Hema Express Platform were evaluated using a
  total of 300 negative sera from a known (normal)
  blood donor population. Abbott HIV 1 / 2 ELISA
  was used as the gold standard methodology for
  comparison
• Results

Positive () Negative (-) Total
Rapid 1-2-3 Hema HIV 0 300 300
Abbott HIV 1 / 2 0 300 300
Specificity 300 / 300 x 100 100
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SUMMARY OF ADDITIONAL AVAILABLE DATA

• Interfering Substances
• Low Titer Panels (BBI PRB 107)
• Anti HIV-1 Mixed Titer Panels (BBI PRB 202 / PRB
  203)
• Anti HIV-2 Performance Panel (BBI PRF 202)
• Anti HIV 1 / 2 Combo Performance Panel (BBI PRZ
  204)
• HIV-1 Seroconversion Panels (BBI PRB 959)
• HIV Seroconversion Panels (NABI SV 400-403, SV
  407-408)

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SUMMARY OF CLINICAL STUDIES AVAILABLE

• Clinical studies performed at University College
  Hospital, Ibadan, Nigeria
• Clinical studies performed at Mhu-Jhu Core Lab,
  New Mulago Hospital, Kampala, Uganda
• Uganda National Blood Transfusion Service,
  Kampala Uganda study
• Data presented at the 10th Conference on
  Retroviruses and Opportunistic Infections, Boston
  USA 2003
• National Institute of Communicable Diseases
  (NICD) study (Johannesburg, South Africa)
• Instituto Commemorativo Gorgas de Estudios de la
  Salud (GORGAS), Republic of Panama clinical study
• Laboratorio Nacional de Salud Publica, Santo
  Domingo, Dominican Republic clinical study

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FEATURES / BENEFITS

• Rapid 1-2-3 Hema HIV EXPRESS

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FEATURES / BENEFITS (EXPRESS DEVICE)
FEATURE BENEFIT
Rapid delivery system Immediate results
Fifteen (15) minute test (or less) Results available at the point-of-care
Easy to use Allows use by minimally trained users
Simple Reduces potential user error
Uses fingerstick whole blood Minimally invasive specimen
Cost effective Suitable for mass screening in less developed nations
Safe, self contained unit Minimizes exposure to potentially dangerous and infectious specimens
Kits supplied with ALL components necessary to perform the test No hidden costs or requirements
Color-coded disease specific kits Easy differentiation by customers in the field
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FEATURES / BENEFITS (EXPRESS DEVICE)(Continued)
FEATURE BENEFIT
Room temperature storage No refrigeration requirements
Long shelf life Bulk procurement possible, saving valuable costs in purchase / shipping
Flexible packaging options Meets customer requirements
Controls available External quality control possible
Pictorial instructions (handbook sized training guide) available Reduces potential user error
High quality manufacturing under US FDA GMP conditions Lot-to-lot manufacturing consistency and quality of product
Proprietary, patented platforms Unique, differentiates HDS from competitors
Assays may be used to test serum / plasma samples Flexible, useful for validations using characterized specimens
Proven in clinical testing Supporting clinical data available
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What makes HDS and its products unique and
different?

• Range of innovative, state-of-the-art
  assays/products supported by solid clinical data
• Flexible packaging to meet varying market
  conditions
• Simple/safe to administer, even by minimally
  trained personnel, in cases of staff shortage
• Excellent order process/fulfillment record
• Backed by outstanding support from well-trained
  staff
• Affordable without sacrificing performance
• Flexible financing for bulk volume purchases

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CONCLUSIONS

• 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

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• 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!!

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• DIAGNOSTIC SOLUTIONS FOR A CHANGING WORLDTM
• info_at_rapid123.com