Zum einen haben sie angeblich schon fertige Tests, die ja auch ausgeliefert werden, andererseits lese ich immer was von Entwicklung der Produkte.
Jetzt werden extra noch zwei Veteranen dazu eingestellt. Welche Produkte sind denn jetzt marktreif(angeblich ja auch mit Genehmigung der FDA) und welche müssen erst noch weiterentwickelt werden?
Calypte Announces Dr. J. Richard George to Head Its Rapid HIV Business
Monday June 30, 9:02 am ET
ALAMEDA, Calif.--(BUSINESS WIRE)--June 30, 2003--Calypte Biomedical
Corporation (OTCBB:CYPT - News):
Dr. George, former Senior VP of Infectious Disease Research and
Development at OraSure Technologies, Inc., and a 30-Plus Year Veteran
of the Centers for Disease Control and Prevention
Dr. Ronald Mink to Co-Lead Calypte's Rapid Business
Calypte Biomedical Corporation (OTCBB:CYPT - News), the developer and
marketer of the only two FDA approved HIV-1 antibody tests for use with urine
samples, announced today changes in personnel assignments in its effort to
develop rapid HIV assays for the U.S. and international markets.
Recent decisions by the Centers for Disease Control and Prevention, the Food
and Drug Administration, and other HIV Prevention agencies have clearly
identified antibody testing as a key component of the effort to reduce the
incidence of HIV infections both in the United States and worldwide. Further, the
quick approval by FDA and acceptance of two blood rapid HIV-1 tests provide
convincing evidence that rapid tests will be important tools in these programs.
Calypte Biomedical has rapid assays under development for the sensitive and
specific detection of HIV antibodies that are present in both urine and whole
blood of infected individuals. Calypte is committed to the rapid development
and introduction of these tests into the worldwide market. To this end, Calypte
has assembled an experienced and capable team of scientists to successfully
complete this project. Leading the effort is Dr. J. Richard George, former Senior
VP of Infectious Disease Research and Development at OraSure Technologies,
Inc., and a 30-plus year veteran of the Centers for Disease Control and
Prevention. While at OraSure, Dr. George had oversight responsibility for the
research and development of all infectious disease products (including its
OraQuick HIV-1 rapid product), domestic and international research
collaborations, and clinical trials for this rapid device. Dr. George stated, "I am
excited and honored to be selected to direct the efforts of this skilled group of
scientists to again produce an important test for containing the spread of HIV."
Co-leader for the project is Dr. Ronald W. Mink, former Director of Research
and Development at OraSure Technology. Dr. Mink has 20-plus years of
experience in the development and commercialization of rapid assays at such
companies as Quidel and Carter Wallace. Dr. Mink was the inventor of the first
OraQuick HIV-1 rapid prototypes (U.S. Patent 6,303,081). Dr. Mink supervised
the OraQuick research and development effort and oversaw product transfer to
production. Dr. Mink's skills and experience will contribute significantly to
shortening the time for introduction of the Calypte rapid HIV tests.
When available, the rapid Calypte urine tests will provide non-invasive
alternatives to blood and will enable Public Health Agencies to use testing
algorithms composed of multiple rapid tests capable of providing a final test
result in outreach settings.
"The experience that both Dr. George and Dr. Mink bring to the company with
their proven track records of delivering rapid test technologies to market, along
with our new President and COO, Jay Oyakawa, gives us a strong management
team to position the company as a leader in Rapid HIV testing," said Anthony
Cataldo, Executive Chairman of Calypte Biomedical.
Jay Oyakawa, President and COO of Calypte, stated, "In many settings both
here in the United States as well as abroad, rapid tests offer some specific
advantages over laboratory-based testing. We intend to capitalize on those
advantages by developing rapid blood and urine tests that meet our customers'
needs, both in terms of price and performance. We are dedicated to putting all
of the necessary resources behind that goal. At the same time, we will continue
to support all of those customers who have come to rely upon our original
FDA-approved urine HIV-1 testing algorithm for batch-based testing."
