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The following is a review of diagnostic product developments worldwide

The information is updated the first week of every month - so ... make this a regular stop in your information gathering activities.

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.

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Product developments in April 1997

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 therapy.

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 FDA approval.

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.

Cytyc Corporation, 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.

DiagnoCure Inc., 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 cancer.

Genentech, 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

Gull Laboratories, 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.

Horus Therapeutics, 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.

Matritech, Inc., 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.

Nanogen Inc., 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.

Oncor, Inc. 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.

Pall Medsep, 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.

Soane BioSciences, 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 of applications.

Chiron Diagnostics 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 resorption.

Cardiovascular Diagnostics, 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 care.

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* 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