Transcript HEMA DIAGNOSTIC SYSTEMS …DIAGNOSTIC SOLUTIONS FOR …

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
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To provide the highest quality rapid diagnostic testing devices to
the global market place in a cost effective manner
Vision Statement
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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?
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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
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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:
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RAPID 1-2-3® HEMA EXPRESS™
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RAPID 1-2-3® HEMA EZ™
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RAPID 1-2-3® HEMA DIPSTICK STRIPS
RAPID 1-2-3®
HEMA
EXPRESS™
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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
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sample pad.
RAPID 1-2-3® HEMA
EXPRESS™
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Prick finger using safety
lancet
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Touch sample pad to drop
of blood
RAPID 1-2-3® HEMA EXPRESS™
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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™
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Insert the assay into
the diluent tube.
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Blood and diluent
flow onto strip.
RAPID 1-2-3® HEMA EXPRESS™
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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.
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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
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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 ®
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The Rapid 1-2-3 Hema® EZ®
device is a simple to use delivery
platform that captures potentially
infected blood within the housing.
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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
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Prick finger with safety lancet
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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 ®
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Place sampler containing the blood collected
into the lower housing.
RAPID 1-2-3® HEMA EZ ®
Push down on
the top of the
diluent filled pod
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Diluent in the pod and the
blood in the sampler are
released.
Sampler
and housing
are locked
in
place.
RAPID 1-2-3® HEMA EZ ®
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Blood and
diluent flow
down onto
the test
strip.
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Within a few
minutes a
Control line
appears
indicating
the test is
functioning
properly.
RAPID 1-2-3® HEMA EZ ®
Read Results
at 15 Minutes
 If the test is
negative,
ONLY the
line (C)
will appear.
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control
If the test is
positive, BOTH
the control
line (C) and
the test
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®
Hema HIV
1,115
2
1,117
Abbott HIV 1 / 2
ELISA
1,117
0
1,117
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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®
Hema HIV
0
1,470
1,470
Abbott HIV 1 / 2
ELISA
0
1,470
1,470
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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®
Hema HIV
262
0
262
Detect™ HIV 1 / 2
262
0
262
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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®
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.
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%
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%
SUMMARY OF ADDITIONAL AVAILABLE DATA
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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
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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
necessary to perform the test
No hidden costs or requirements
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
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
What makes HDS and its products
unique and different?
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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…
[email protected]