Mission and vision statements


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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?





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 lancet



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 the diluent tube.



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.



  • 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 ®



RAPID 1-2-3® HEMA EZ ®



RAPID 1-2-3® HEMA EZ ®

  • Blood and diluent flow down onto the test

  • strip.



RAPID 1-2-3® HEMA EZ ®

  • Read Results

  • at 15 Minutes

  • If the test is negative, ONLY the control line (C) 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



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:



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



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:



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:



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:



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)



FEATURES / BENEFITS (EXPRESS™ DEVICE) (Continued)



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



  • 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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