HEMA DIAGNOSTIC SYSTEMS (HDS) by A6p1tHMD

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									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      Saõ Paulo, Brazil
                   Panama City, Panama
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
   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 R&D facility (North Bay
  Village, Florida)
 November 2005: Opened new HDS branch office in São Paulo,
  Brazil
 February 2006: Joined Global Business Coalition (GBC)
  SUMMARY OF HDS
PRODUCTS / 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 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 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
       PACKAGING
Color coding on (foil) packaging
matches color coding of
test strips in the various
product formats
     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
    application in developing
    nations.
   Whole blood, serum or
    plasma specimens
   Room temperature storage
   Long shelf life
   Safe
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.
            RAPID 1-2-3® HEMA
               EXPRESS™

   Prick finger using safety      Touch sample pad to
              lancet                   drop of blood
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.
RAPID 1-2-3® HEMA EXPRESS™


   Insert the assay into      Blood and diluent
    the diluent tube.           flow onto strip.
RAPID 1-2-3® HEMA EXPRESS™


     Within a few
      minutes a
      Control line
      appears
      indicating the
      test is
      functioning
      correctly.
RAPID 1-2-3® HEMA EXPRESS™


   Read the Result at
    15 minutes
   If the test
    is negative,
    ONLY the
    Control
    line (C)
    will appear.
 RAPID 1-2-3® HEMA EXPRESS™

 If the test is
positive, then
BOTH the
Control line (C)
and the Test line (T)
will appear
     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.
    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.
    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
         RAPID 1-2-3®HEMA EZ ®
   Place sampler containing the blood collected
    into the lower housing.
      RAPID 1-2-3® HEMA EZ ®

  Push down on         Diluent in the pod and the
the top of the           blood in the sampler are
diluent filled pod       released.
                         Sampler
                         and housing
                         are locked         in
                         place.
         RAPID 1-2-3® HEMA EZ ®


   Blood and                Within a few
    diluent flow              minutes a
    down onto                 Control line
    the test                  appears
    strip.                    indicating
                              the test is
                              functioning
                              properly.
  RAPID 1-2-3® HEMA EZ ®

Read Results
at 15 Minutes
 If the test is       If the test is
  negative,             positive, BOTH
  ONLY the              the control
  control               line (C) and
  line (C)              the test
  will appear.          line (T)
                        will appear
   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)
HIV CLINICAL DATA
DIPSTICK AND EXPRESS™
         DATA
  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®           1,115         2       1,117
        Hema HIV
        Abbott HIV 1 / 2       1,117         0       1,117
        ELISA

             Sensitivity = 1,115 / 1,117 x 100% = 99.8%
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®                 0           1,470       1,470
    Hema HIV
    Abbott HIV 1 / 2             0           1,470       1,470
    ELISA

          Specificity = 1,470 / 1,470 x 100% = 100%
   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®              262           0         262
             Hema HIV
             Detect™ HIV 1 / 2         262           0         262


                 Sensitivity = 262 / 262 x 100% = 100%
      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®               0            30            30
             Hema HIV
             Detect™ HIV 1 / 2          0            30            30


              Specificity = 30 / 30 x 100% = 100%
              100% Concordance with the reference ELISA assay.
                  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®               192           0         192
             Hema HIV
             Abbott HIV 1 / 2           192           0         192


               Sensitivity = 192 / 192 x 100% = 100%
                 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®               0          300        300
            Hema HIV
            Abbott HIV 1 / 2           0          300        300


              Specificity = 300 / 300 x 100% = 100%
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)
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
FEATURES / BENEFITS
   Rapid 1-2-3® Hema HIV
        EXPRESS™
  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    No hidden costs or requirements
necessary to perform the test
Color-coded disease specific kits    Easy differentiation by customers in the
                                     field
  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 Reduces potential user error
training guide) available
High quality manufacturing under US   Lot-to-lot manufacturing consistency and
FDA GMP conditions                    quality of product
Proprietary, patented platforms       Unique, differentiates HDS from
                                      competitors
Assays may be used to test serum /    Flexible, useful for validations using
plasma samples                        characterized specimens
Proven in clinical testing            Supporting clinical data available
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
   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
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
     CHANGING WORLDTM…



         info@rapid123.com

								
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