HEMA DIAGNOSTIC SYSTEMS (HDS) …DIAGNOSTIC SOLUTIONS FOR A CHANGING WORLD™… Dr. Paul D Slowey Executive Vice-President Hema Diagnostic Systems May 2006 North Bay Village, Florida USA Saх Paulo, Brazil Panama City, Panama

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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

• 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

• 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

• 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

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

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

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)
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FEATURES / BENEFITS (EXPRESS DEVICE)(Continued)
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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