Trinity has the rights to the HIV-2 patent. Acquired from Selfcare purchase recently announced.
Recall Dr. Branson made special mention of the Capillus HIV 1/2 test which we now own:
trinitybiotech.ie
Thursday October 1, 12:01 pm Eastern Time
Trinity Biotech Acquires HIV Business From
Selfcare, Inc.
DUBLIN, Ireland--(BW HealthWire)--Oct. 1, 1998--Trinity Biotech plc (NASDAQ:TRIBY)
today announced that it has acquired the infectious disease diagnostics business of Cambridge
Diagnostics Ireland Ltd., a subsidiary of Selfcare, Inc. of Waltham, MA (AMEX:SLF) for a
consideration of 555,731 shares of Selfcare, Inc. common stock owned by Trinity Biotech,
and $280,000 in cash.
The product range, which had 1997 revenues of $3.2 million, comprises three tests for the
diagnosis of HIV antibodies. Capillus HIV 1/2 and RTD HIV 1/2 are rapid tests that detect
HIV antibodies in whole blood, serum or plasma, and are ideally suited for use in physicians'
offices, emergency rooms, clinics, and other point-of-care situations. The third product
(Recombigen) is a microtitre plate assay, which is used for diagnosis of HIV in clinical and
reference laboratories, and is also used in blood banks for screening of blood donations.
As part of this transaction, Trinity has acquired the rights to certain recombinant antigens
which are used in other retroviral diagnostic products approved by the FDA and which will
enhance the performance characteristics of Trinity's Uni-Gold(tm) HIV.
''This acquisition is an excellent fit for Trinity, as it broadens our product offering in a high
growth market segment where we already have a substantial presence through our rapid HIV
products SeroCard, SalivaCard, and Uni-Gold,'' stated Ronan O'Caoimh, CEO of Trinity
Biotech. ''Trinity is now the market leader world-wide in rapid HIV testing.''
''Furthermore, as Capillus and Recombigen are the preferred HIV test of the World Health
Organisation, Trinity will be able to access significant HIV markets, such as India and Central
and East Africa, where we previously had minimal presence. The transfer of production to
our new facility in Ireland will yield significant manufacturing efficiencies resulting in
improved margins,'' O'Caoimh continued. ''We are particularly pleased that this acquisition,
which will be earning enhancing, has been realised largely from the retirement of Trinity's
shareholding in Selfcare, Inc. and hence, is non-dilutive.''
Trinity Biotech develops, manufactures, and markets over 100 diagnostic products for the
point-of-care (POC), self-testing (OTC), and clinical laboratory segments of the diagnostic
market. Trinity sells worldwide in over 75 countries through 130 international distributors
and strategic partners, including Warner Lambert, Carter Wallace, and SmithKline Beecham.
Read down to the bottom.
People want Rapid tests. "New rapid HIV tests will eventually find their way not only into the U.S. market, but into home-test kits as well, Slowey adds. "It's simple: Consumers want to know."
Trinity has the HIV-2 license, Saliva Diagnostics does not!!!
ahcpub.com
CDC launching new era in
testing by giving OK to rapid
screening tests
New fingerstick tests will bring access to
the streets
In a move that is likely to have profound and far-reaching
consequences, the Centers for Disease Control and Prevention
has made an about-face on rapid HIV screening tests.
In the Feb. 27, 1998, issue of Mortality and Morbidity Weekly
Report, the CDC will recommend a change in U.S. Public Health
Service policy. It will urge that under at least some circumstances,
health care providers should be able to disclose provisional
results of HIV tests, instead of making patients wait two weeks
while a confirmatory test is performed.
The new recommendations are expected to be incorporated into
regulations by the U.S. Food and Drug Administration (FDA). When
that happens, the effect will be the opening of a vast new market in
the United States for rapid HIV screening tests, CDC experts say.
Though dozens of rapid tests are already in widespread use
abroad, scant incentive exists for test manufacturers to mount the
expensive clinical trials needed for approval in the United States,
because the FDA at present prohibits the disclosure of provisional
rapid-test results, says Bernard M. Branson, MD, MPH, medical
epidemiologist at the National Center for HIV, STD and TB
Prevention at the CDC, and chief architect of the new CDC
recommendations.
With a new policy in place, many new rapid tests for HIV will be
submitted for FDA approval, experts say. Most of the new tests are
simple fingerstick tests that incorporate a new technology
perfected within the last year, and which — in theory — could be
used by anyone, from outreach workers to consumers of
home-test kits.
Two new tests are in clinical trials, a third is already available, and
another is expected to become available within the next year or so,
CDC experts say. (For details, see story, p. 26.)
The anticipated influx of new rapid tests promises to have a
dramatic impact in two different ways. First, the new tests will
greatly increase access, making it much easier for people to learn
their HIV status, says Branson.
"By cutting down on the cost and the technological requirements of
rapid tests, and by getting rid of the waiting time, HIV testing
doesn't have to be clinic-based anymore," he says. "Now it can
done as street outreach."
Indeed, one reason driving the CDC's turnaround on rapid tests
was researchers' frustration over the effects of a two-week waiting
period. As it stands now, almost 30% of U.S. patients who get HIV
testing never come back for their results, says Charles A. Schable,
chief of the National Center for Infectious Disease at the CDC.
Studies have found that the waiting period is too burdensome for
clients who have a hard time taking off from work or finding child
care, Branson says.
But when clients in a Dallas study were given the chance to learn
their test results right away, they understood the provisional nature
of positive results, and they also came back to get confirmation
and more counseling, Branson says.
The second arena in which new tests will make an impact relates
to accuracy. Studies in Honduras and other sites abroad have
shown that using two different rapid tests side by side provides far
greater accuracy than using a single rapid test alone, Branson
says. Rapid tests could be used in the same fashion in the United
States if there were more than one on the market; but without a
new policy on the disclosure of results, that would never happen,
researchers realized.
Ethical concerns are raised by the prospect of outreach workers
offering injecting drug users an on-the-spot HIV test, or home-test
consumers being able to perform an instant test on themselves,
say Branson and Schable. How will clients decide whether or not
they are ready to get on-the-spot information about their HIV
status? How will counselors help clients understand a
provisionally positive result?
As this issue of AIDS Alert went to press, the new CDC
recommendations called for disclosure of provisional results by
clinicians only in certain circumstances, says Schable. Tests were
to be offered to the following kinds of clients:
• those in high-risk populations (such as those presenting at TB
and STD clinics);
• mothers presenting in labor, with no history of prenatal care and
with unknown HIV status;
• health care workers who are victims of a needlestick, and
possibly other high-risk situations.
Ways to convey provisional positive results were also still being
worked out at press time. For example, patients who test positive,
but who live in a low-prevalence part of the country and engage in
no activities that put them at risk for HIV infection, might be told a
positive reaction means they "probably" or "very likely" don't have
HIV. In higher-risk settings, patients might be told that a positive
test means they "probably are" infected.
Whether the tests will perform as well in the United States as they
have abroad is still unknown, experts add. For one thing, using a
single rapid test in a low-prevalence population will give a lower
positive predictive value, says Branson.
Suppose, for example, a single rapid test that has 99.4% specificity
is administered to 1,000 people, meaning six will test
false-positive. That error rate won't matter much in areas with a
high prevalence of HIV, because in all probability the people testing
false-positive will have the disease. But if the same test was
performed on 1,000 white, affluent suburban housewives — a
low-prevalence population — in all likelihood all positive results
will be false, and positive predictive values plummet to zero.
Two rapid tests used together abroad seem to overcome that
difficulty by ensuring virtually 100% accuracy. However, no one
knows for sure if paired tests will perform the same way here as
they do abroad. "I have confidence in these tests, but until we have
more data, we can't extrapolate and say for sure how they will work
here," says Mark Rayfill, PhD, assistant chief for Interna tional
Laboratory Activities of the HIV Retrovirus Disease Branch of the
Division for AIDS, STDs, TB and Laboratory Research at the
National Center for Infectious Diseases. To get those data,
researchers need more rapid tests, Rayfill adds.
But two other roadblocks may keep the tests from reaching the
market as fast as researchers would like.
For one thing, Paris-based Sanofi Diagnostics, Pasteur, holds
patent rights in the United States to the HIV-2 antigen, which the
FDA says new HIV tests must be able to detect to be approved.
Thus, it's possible other companies submitting products for
licensure could face a court challenge.
The bigger hurdle, at least for some pharmaceutical firms, is
simply cost. Saliva Diagnostics Systems (SDS), a small firm
based in Vancouver, WA, has three rapid tests it would like to
launch in the United States. But without a backer, that will prove
tough, says Paul Slowey, PhD, chief operating officer and vice
president of SDS.
"People want these kinds of tests very badly right now," says
Slowey. That's why the new rapid HIV tests will eventually find their
way not only into the U.S. market, but into home-test kits as well,
Slowey adds. "It's simple: Consumers want to know."
order now! home page contact ahc
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