Pittsburgh Firm Prepares to Set the Standard in Rapid HIV Testing
PITTSBURGH, Aug. 6 /PRNewswire/ -- A new weapon in the battle against the worldwide AIDS epidemic is set to be unleashed. BICO, Incorporated (OTC Bulletin Board: BIKO) subsidiary Rapid HIV Detection Corp. (Rapid Corp.) has acquired the worldwide marketing rights for a new HIV diagnostic test known as InstantScreen(R).
Since making the initial announcement on this acquisition a week ago, BICO has received an extraordinary high number of inquiries. In response, we will list the advantages of InstantScreen.
* 100% accurate -- recently tested by the Walter Reed Army Institute of Research and others (1)
* Instant results -- within 30 seconds or less
* Simple to use -- InstantScreen requires no special training, extra
equipment, or refrigeration, uses only a small amount of finger prick
blood, and anyone who can read at least on an elementary level can
administer the test
* Affordable -- $10 or less in most instances
* Quick Confirmation -- results of test can be verified within minutes
(2)
Initially, InstantScreen will be marketed in Africa, India, South America, the Caribbean and Asia. These regions of the world have the highest percentages of AIDS that exists today. Rapid Corp. and the Manufacturer of InstantScreen, the German American Institute for Applied Research (GAIFAR), have begun the process to seek FDA approval of InstantScreen for use within the United States. Other less accurate tests have shown false positives and negatives. Inaccurate tests can literally mean the difference between life and death.
The marketing rights were obtained from GAIFAR in Potsdam, Germany, where InstantScreen was developed by Dr. Heinrich Repke. Dr. Repke has a Ph.D in Immunology, a D.Sc in Molecular Pharmacology, and spent 5 years as an Assistant Professor of Pathology and of Genetics at Harvard Medical School. Following this release are answers to the most frequently asked questions concerning the InstantScreen test.
BICO, Incorporated has its corporate offices in Pittsburgh, PA and is involved in the development and manufacture of biomedical devices and environmental solutions. The Company also has offices in Washington, D.C. as does Pittsburgh-based subsidiary Rapid Detection Corp.
(1) In nearly 600 tests, the Walter Reed Army Institute of Research, HIV Research Program, in Washington, D.C., InstantScreen has performed with 100% accuracy. Walter Reed will continue its research with the product because of this positive outcome.
In approximately 200 tests performed by the Noguchi Memorial Institute for Medical Research in Accra, Ghana, InstantScreen performed with 100% accuracy.
250 samples in a Phase 1 Evaluation of InstantScreen by the World Health Organization performed with 100% accuracy.
150 Samples evaluated by the National institute for Virology in South Africa showed 100% accuracy.
InstantScreen was tested against the widely internationally accepted laboratory tests known as ELISA (screening test) and Western Blot (confirmation test) with 100% accuracy.
(2) InstantConfirm is the first test to transform the widely used gold standard Western Blot laboratory test into a rapid format, usable immediately to confirm a positive result. Confirmation results are obtained in 8 minutes or less. No other test on the market has a companion rapid confirmation test. Use of the Western Blot laboratory confirmation test usually costs $50-$90 each. Necessary manpower and transportation to and from the laboratory from the point of screening would be an extra cost. Results would take days or weeks. InstantConfirm results cost a fraction and the results are known before the patient leaves the testing site. There is also an accompanying test to determine HIV-1 or HIV-2.
The following are questions most often asked of BICO, Incorporated regarding the rapid test acquisition:
What is InstantScreen?
InstantScreen is a finger-prick blood test that can quickly determine if someone is infected with HIV, the virus that can cause AIDS. The advantages of InstantScreen are:
* It is 100% accurate -- InstantScreen can determine without any errors
if someone is or is not infected with HIV, because it only detects the
HIV virus and doesn't get confused by the presence of other viruses or
antibodies in the body. Preliminary tests results from studies on
InstantScreen by the Walter Reed Army Institute of Research, HIV
Research Program showed 100% accuracy on nearly 600 tests.
* It is fast -- InstantScreen delivers results in 30 seconds or less.
* It is very easy to use -- InstantScreen requires no special training,
extra equipment, or refrigeration, uses only a small amount of finger
prick blood, and anyone who can read at least on an elementary level
can administer the test.
* It is quickly confirmable -- InstantScreen is the only rapid assay with
an accompanying rapid confirmation for use when a positive result has
been obtained with InstantScreen.
Why does the world need a rapid HIV test?
* The spread of HIV/AIDS must be stopped or it will affect the world as a
whole, both socially and economically.
* In order to stop the spread of HIV/AIDS, the people who have it must be
identified then counseled to change their lifestyle. To deal with a
problem you must first know where the problem exists.
* Often people will show up for an HIV test but do not return to obtain
the results that take days, even weeks to obtain. This is especially
true in developing countries where there is fear and lack of knowledge.
* In these developing countries, there are overwhelming numbers of people
to test. So, if a test can be administered and give results very
quickly, more people can be tested in a day. The sooner infected
people are identified the sooner that counseling and behavior change
can occur and the spread of HIV/AIDS stopped.
* Pregnant women with an unknown HIV infection status who are about to
give birth can quickly be tested to help prevent infection of the
infant. Recipients of emergency blood donations could similarly
benefit.
Aren't there already other rapid HIV detection tests on the market?
* As testimony to how badly such a test is needed, there are
approximately 70 rapid HIV tests of one type or another in existence.
However, none is FDA approved. None can exhibit all of the assets of
InstantScreen. GAIFAR, with assistance from BICO subsidiary Rapid HIV
Detection Corp., is currently in the process of applying for FDA
approval.
* Its ease of use, accuracy, relative lack of temperature sensitivity,
small amount of finger prick blood needed, and the permanence of the
results make InstantScreen the best choice for rapid HIV testing.
* No other test on the market also has a companion rapid confirmation
test.
How does the confirmation test work?
* InstantConfirm(R) -- used to confirm a positive reaction obtained with
InstantScreen -- for the first time ever, the internationally accepted
laboratory confirmation test known as the Western Blot has been
transformed for use wherever a rapid test is used. Using another
finger prick blood sample, confirmation results are obtained in
8 minutes or less. This is truly an important development as the
availability of such a rapid confirmation test quickly and cheaply
provides the same laboratory results that now take days, even weeks and
is expensive to obtain.
* InstantDifferentiate(R) -- comes with InstantConfirm to rapidly
determine whether the confirmed HIV infection is the less aggressive
HIV-2 or the more aggressive HIV-1 so appropriate treatment and
counseling can be administered.
How can InstantScreen be 100% accurate?
* The ability to detect the presence OR the absence of the HIV virus with
absolute accuracy is possible due to two things: 1. the "designer
proteins" which identify only HIV, filtering out all other infectious
diseases so prevalent in developing countries, and 2. the novel
proprietary detection system which make the presence of antibodies
against any type of HIV easily visible.
How is it known that InstantScreen is 100% accurate, in detecting both infected and noninfected blood?
* In nearly 600 tests, the Walter Reed Army Institute of Research, HIV
Research Program, in Washington, D.C., InstantScreen has performed with
100% accuracy. Walter Reed will continue its research with the product
because of this performance.
* In approximately 200 tests performed by the Noguchi Memorial Institute
for Medical Research in Accra, Ghana, Instant Screen performed with
100% accuracy.
* In a Phase 1 Evaluation of Instant Screen by the World Health
Organization on 250 samples, the accuracy was 100%.
* In a National Institute for Virology in South Africa, an evaluation of
150 samples showed InstantScreen to be 100% accurate.
* InstantScreen was tested against the widely internationally accepted
laboratory tests known as ELISA (screening test) and Western Blot
(confirmation test) with 100% accuracy.
Is InstantScreen ready for market?
* YES. The product is fully developed and is ready for market.
Will Rapid Corp. manufacture the family of rapid HIV tests?
* No. The tests will continue to be manufactured by GAIFAR, which is and
has been manufacturing the products in accordance with all requirements
of the German drug law. All products are approved for export to all
countries where the testing kits will be marketed.
Where will InstantScreen be sold?
Initially, the Company will make the rapid HIV detection test available in:
* Africa
* India
* South America
* Caribbean
* Asia
These markets have been chosen, of course, because of the widespread AIDS problem that exists there, causing a real need for help. In these markets, falsely identifying someone as having AIDS can cause them to be branded as outcasts and can literally be a death sentence. Falsely identifying someone as uninfected continues the spread of infection. With its accuracy, ease of use, and speed of results, InstantScreen can definitely help these areas to slow, even stop, the spread of HIV/AIDS.
* InstantScreen can be sold in these markets immediately.
What will the InstantScreen cost?
* The cost per person tested will range from $8 to $12.
How much does InstantConfirm cost?
* The InstantConfirm is necessary only when a positive result is obtained
from the InstantScreen test. Without InstantConfirm, the only choice
is the use of the Western Blot laboratory confirmation. That can cost
$50 - $90 for each test. Add to that the costs of manpower and
transportation to get the test to the laboratory from point of initial
screening. The InstantConfirm test can be completed for under $20.
Additionally, there are significantly reduced administration costs with
InstantConfirm because it is so simple to give and needs no extra
supplies. The test can literally be given in the African countryside
with results returned within minutes.
This document contains statements of a forward-looking nature. Shareholders and potential investors are cautioned that such statements are predictions and actual events or results may vary significantly.
FOR FURTHER INFORMATION, CONTACT:
Investors Media
Diane McQuaide Susan Taylor
1.412.429.0673 phone 1.412.429.0673 phone
1.412.279.9690 fax 1.412.279.5041 fax
INVESTOR RELATIONS NEWSLINE NUMBER: 1.800.357.6204 www.bico.com
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SOURCE BICO, Incorporated
/CONTACT: Investors, Diane McQuaide, +1-412-429-0673, or fax,
+1-412-279-9690, or Media, Susan Taylor, +1-412-429-0673, or fax,
+1-412-279-5041, both of BICO, or BICO Investor Relations Newsline,
+1-800-357-6204/
/Web site: bico.com |
