The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.
American Biogenetic Sciences,
Inc., Boston, Mass, has reported the results of the recently conducted
Italian Neurosurgery Enoxaparin Study-TpP (INES-TpP) at the 29th
Oak Ridge Conference in St. Louis, MO. The study indicated that
elevated preoperative plasma levels, of soluble fibrin polymers,
as measured by ABS' proprietary TpP Assay, were found in patients
who developed proximal deep vein thrombosis (DVT) after elective
neurosurgery. ABS' TpP assay has been cleared by the FDA to aid
in the risk assessment of thrombosis and the monitoring of anticoagulant
Bard Diagnostic Sciences,
Redmond, Wash has launched its POC BTA stat test provides smokers
and other high-risk groups with a powerful management tool in
the fight against bladder cancer. Using the same technology commonly
seen in one-step pregnancy tests, the BTA stat test can be performed
in a doctor's office. The new test could be a life-saver for
smokers who are at greatest risk for bladder cancer -- experiencing
twice the risk of nonsmokers. In fact, smoking is estimated to
be responsible for approximately 47 percent of the bladder cancer
deaths among men and 37 percent among women, according to the
American Cancer Society. The Bard BTA stat test recently received
The US FDA cleared the way for Haemonetics
Corporation to market its automated red cell collection devices
that collect two units of red cells. The FDA's 510(k) premarketing
clearance which allows Haemonetics to market the devices follows
by one year, FDA's 510(k) clearance for the same devices to collect
two red cell units from patients donating blood for their own
surgical use. Haemonetics is the only company with FDA clearance
to market these devices.
Boxborough, Mass, and CompuCyte Corporation announced today that
CompuCyte's Pathfinder information system has been modified to
support Cytyc's ThinPrep Pap Test. The Pathfinder System is a
specially designed microcomputer that attaches to laboratory microscopes
and provides quality assurance, information management and process
control during microscope slide examination. Originally designed
for the rectangular shape of conventional Pap smear microscope
slides, the Pathfinder has been modified by CompuCyte to also
accommodate the circular shape of the ThinPrep Pap Test.
Dade International and Marquette Medical
Systems have agreed to work together
to help hospitals successfully adopt a proven model for improving
diagnosis and treatment of patients with chest pain. The "chest-pain
center model" is a systematic approach to evaluating patients
who arrive at a hospital emergency room complaining of chest pain.
The goal is to assure proper treatment as soon as possible while
avoiding unnecessary treatment or hospital stays for persons not
having a heart attack. Dade supplies systems that test for cardiac
markers and Marquette supplies 12-lead ECG monitoring equipment.
American Drug Stores, Concord, Mass, the parent
company of Osco and Sav-on pharmacies, and MediLife, Inc. has
decided to sell Balance PC Diabetes Software. The regional
leaders of 12 U.S. markets will offer Balance PC either off the
shelf or through special orders. Balance PC Diabetes Software
is a comprehensive program for people with diabetes to monitor
and better understand their condition. By using Balance PC, people
with diabetes can work with their healthcare professionals to
customize treatment plans for tighter blood glucose control --
the key to avoiding complications for the eight million Americans
diagnosed with diabetes.
Sainte-Foy, Quebec, has acquired the exclusive worldwide rights
to develop and commercialize two innovative molecules derived
from growth factors (HARP and VEGF) interesting for the diagnostic
and treatment of various cancers and more specifically for prostate
Inc., S, San Francisco, Calif, has been granted a US patent for
methods to treat hemophiliacs with recombinant human Factor VIII
and recombinant human Factor VIII as a pharmaceutical
Inc., Salt Lake City, Ut will acquire the diagnostics business
of the Intensive Care and Diagnostics Division of Fresenius AG.
Gull expects that the combination of the two businesses will
result in a significantly stronger position for Gull in the European
diagnostics market through better customer orientation and more
efficient marketing and sales activities. Fresenius Diagnostics
offers a wide range of blood-typing test sera and reagents for
human leukocyte antigen (HLA) tissue typing, test kits to diagnose
infectious and autoimmune diseases, and automated systems. Fresenius
Diagnostics markets its products in Europe, in particular in Germany,
and had sales of $8.3 million in 1996.
Savannah, Ga, has developed two neural network programs available
to clinicians to help diagnose ovarian and prostate cancer. OophAsure,
analyzes the biochemical changes which occur when ovarian cancer
begins to develop and is expected to be available to physicians
by the fall of 1997. The company already markets ProstAsure,
a test for analyzing biochemical changes at the first sign that
cancer of the prostate is beginning to develop. ProstAsure uses
a computerized neural network to make PSA test results more informative
by combining it with two other tumor indicators and a patient's
age to provide a single value index of disease for physicians.
Horus' analysis of a patient's serum is the first ever to be
delivered over the Internet to any serum laboratory, hospital,
clinic or physician anywhere in the world.
Intelligent Medical Imaging,
Inc. and Immuno Concepts, N.A. LTD, have signed an exclusive marketing
agreement. Under the terms of the agreement, Immuno Concepts'
patented Colorzyme immunoenzyme technology, when used on automated
systems, can only be used on Intelligent Medical's MICRO21 system.
Immuno Concepts slide test-kit will be used in conjunction with
the MICRO21's Anti-Nuclear antibody analysis (ANA analysis) and
nDNA analysis procedures.
Diagnostic Products Corp.,
Los Angeles, Calif, has launched its third-generation PSA Assay
for its Immulite system. Conventional PSA assays have a sensitivity
of about 0.05 ng/mL in serum, but the IMMULITE PSA assay can measure
as little as 0.002 ng/mL and has a clinically useful decision
threshold of 0.01 ng/mL.
Newton, Mass has completed its performance qualifications for
the first production lots of its blood-based colon cancer detection
assay. Matritech's colon cancer product is the company's second
cancer detection product and, like the recently approved NMP22
Test Kit for use in the management of bladder cancer patients,
is based on the company's proprietary nuclear matrix protein technology.
International Murex Technologies
Corporation, Toronto, has introduced its ICE Syphilis assay, a
novel recombinant-based syphilis enzyme immunoassay that utilizes
the company's ICE format and its trademarked Sample Addition Monitor
technology. Designed for both blood screening and clinical diagnosis,
the test is both sensitive and specific and improves significantly
the reliability of the laboratory diagnosis of syphilis.
San Diego, Calif. and Prolinx Inc. have entered into a Sponsored
Research Agreement that focuses on the development of an enhanced
sensitivity detection system for use with Nanogen's proprietary
electronically addressable microchip array technologies. The
collaboration adapts Prolinx's expertise in oligonucleotide immobilization,
fluorescence detection and signal amplification on Nanogen's microchip-based,
miniaturized DNA array platform.
has developed the Sunrise Amplification Detection System for the
direct quantitative analysis of DNA amplification reactions.
The system allows the researcher to perform nucleic acid amplification
reactions, such as PCR, in a completely closed tube format. This
ability to carry out the amplification reaction and detection
in the same tube addresses two of the most problematic aspects
of amplification assays. The first element involves eliminating
the risk of carry-over contamination of subsequent amplification
reactions with the product of the first reaction. The second
element is the time and labor associated with the post amplification
analysis of the product. The Sunrise Amplification Detection System
consists of a labeled amplification primer, which when incorporated
into the amplification product, generates a fluorescent signal.
Oralife, Toronto has introduced a POC diagnostic
test for Streptococcus mutans bacteria in human saliva. The test
measures the presence or absence of this bacteria, clinically
proven to be a cause of tooth decay, above a certain threshold
known to be associated with the onset and progression of tooth
decay. This test will permit dentists to quickly evaluate an
important factor directly linked to the cause of tooth decay,
Streptococcus mutans in the mouth. The Company plans to begin
test marketing this product in Canada under its pharmaceutical
products division, Knowell Therapeutics, later this year.
Thermogenesis Corp., East Hills, NY and the New York Blood Center
have entered into a licensing agreement to develop a sterile collection
and storage system for the processing of hematopoeitic stem cells
sourced from placental/umbilical cord blood. The system is designed
to simplify and streamline the collection, concentration, cryopreservation
and transfusion of the cord stem cells while maintaining the highest
stem cell population and cell viability possible.
Hayward, Calif, has received an exclusive license in certain fields
from Lawrence Livermore National Laboratory to patented technology
for the integration of two chip-based versions of DNA analysis
procedures commonly practiced on bench-top laboratory equipment.
The integration of PCR and chip-electrophoresis technologies
has the potential to greatly enhance DNA analysis in a number
and Metra Biosystems Inc. have developed Chiron Diagnostics'
ACS:180 DPD for bone resorption, based on Metra's Pyrilinks-D
technology, provides a quantitative measure of the urinary excretion
of deoxypyridinoline (DPD) crosslinks, an accepted marker of bone
Inc. has signed a development agreement with Eli Lilly and
Company to use CVDI's dry chemistry technology (the Thrombolytic
Assessment System, or TAS) to develop a rapid point of care test
to monitor a therapeutic anticoagulant presently under development
at Lilly for use in the treatment of sepsis.
Glyko Biomedical Ltd.,
Novato, Calif, and Array Medical, Somerville, N.J. have entered
into an agreement to jointly develop a diagnostic blood test for
heparin measurement. Array will fund development of a point-of-care
test system which includes an instrument platform and reagents.
Glyko will provide its expertise in heparin assay development
and Array will market the device on a world-wide basis for use
during surgical and medical procedures including open heart surgery,
coronary and vascular angioplasty, kidney dialysis and critical
Product developments - March 1997
Product developments - February 1997
Product developments - January 1997
Product developments - December 1996
Product developments - November 1996
Product developments - October 1996
Product developments - September 1996
Product developments - August 1996
Product developments - July 1996
Product developments - June 1996
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Last modified: May 02, 1997