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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 June 1996

Inter Medico, Markham, ON has announced several expansions of their product menu. The company has obtained exclusive Canadian market rights to products manufactured by Zymed laboratories, including immunohistopathology products, cell biology products and ELISA immunoassay reagents. As of July 1, Inter Medico has exclusive Canadian distribution rights for all Bartels products. In addition, the company has recently introduced Streck Laboratories' Cyto-Chex Reagent, a white blood cell preservative used to preserve whole blood specimens for up to 7 days prior to immunophenotyping by flow cytometry.

Research Medical Inc., Salt Lake City, announced that it has received permission from the U.S. Food and Drug Administration (FDA) to begin human clinical testing of the company's patented Autologous Fibrinogen Delivery Kit (AFD). The purpose of the studies will be to evaluate the AFD Kit as a means of achieving topical hemostasis -- the prevention of blood loss through controlled clot formation -- at a surgical site. The initial markets for the Autologous Fibrinogen Delivery Kit will be cardiac surgery, burn patients and plastic and facial reconstructive surgery.

Immunomedics, Morris Plains, NJ resented partial results from a Phase III study showing that LeukoScan achieved 87% specificity in diagnosing atypical acute appendicitis. The study was performed by Dr. Bruce Barron of the University of Texas Medical School. The study included 28 patients who were injected with LeukoScan and were imaged one to four hours later. The findings showed that LeukoScan had a sensitivity (true-positive rate) of 100% in diagnosing patients who were confirmed as having appendicitis and a specificity (true-negative rate) of 72% in diagnosing patients confirmed as not having appendicitis. LeukoScan is an antibody fragment (Fab') that seeks out and binds to granulocytes (white blood cells) associated with a wide range of infectious diseases and carries the radioisotope technetium-99m directly to the infectious site.

Baxter Healthcare Corporation, Deerfield, ILL announced that its hemoglobin therapeutic HemAssist (also known as Diaspirin Cross-linked Hemoglobin or DCLHb) has been cleared to enter Phase III clinical trials in the United States.

Becton, Dickinson and Company has filed a patent for a method for forming blood compatible, shear sensitive gel formulations including a polydimethylsiloxane-polyethyleneoxide copolymer gelled with dibenzylidine sorbitol in the presence of water or alcohol. The gel formulations are useful for facilitating the separation of blood serum or plasma from the cellular portion of blood or as a thermoreversible shear sensitive substance.

Biomerica, Newport Beach, CA, will introduce a 5 minute rapid diagnostic test for detecting Prostate Specific Antigen (PSA). The new PSA, EZ- PSA, test will be first marketed outside the United States and later will be sold in the U.S. after receiving FDA clearance. The EZ-PSA test utilizes an advanced technology and is as simple to use as a home pregnancy test. The test only requires a few drops of blood.

Bio-Rad Laboratories, Hercules, CA announced that it has entered into a cooperative research and development agreement with Los Alamos National Laboratory for the joint development of a lightweight, compact flow cytometer system, which will then be manufactured by Bio-Rad. This system can rapidly count and characterize small particles and is expected to find widespread uses in clinical, research and other applications. The primary focus is on developing the system's capabilities for the field of microbiology, an area where Bio-Rad is already focused with its existing flow cytometer unit, the BRYTE HSTM.

Biosite Diagnostics, La Jolla, CA is developing a rapid and miniature assay for detecting the amount or presence of target ligand in a sample. The assay includes a ligand analogue conjugate having a linkage site and a binding site, a ligand receptor, and a sample. The assay includes the steps of providing at least one crosstalk inhibitor. This inhibitor, under assay conditions, competes with the linkage site of the ligand analogue conjugate for binding to the ligand receptor, and does not compete with the binding site of the ligand analogue conjugate for binding to the ligand receptor. In the invention, the assay is performed for the target ligand in the presence of a sufficient amount of the crosstalk inhibitor to reduce the amount of binding of the linkage site of the ligand analogue conjugate to the ligand receptor. The invention also features a method for identifying crosstalk inhibitors, and the crosstalk inhibitors themselves.

Cytyc Corporation, Boxborough, Mass., announced the launch of a clinical study with Digene Corporation combining Cytyc's ThinPrep Pap Test for cervical cancer screening with Digene's Hybrid Capture Assay for human papillomavirus (HPV). Combined usage of the two tests should demonstrate the clinical efficacy and cost-effectiveness of conducting both tests from a single cervical cell sample. Many women whose Pap smears are diagnosed as inconclusive are called back for additional testing or are treated as if they have a cervical abnormality even though only an estimated 25 to 35 percent of these women actually have cervical disease. Consequently, women with inconclusive Pap smears often undergo colposcopy, biopsy and unnecessary office visits. The clinical trial is designed to demonstrate a method to clarify inconclusive diagnoses by testing for HPV with Digene's Hybrid Capture Assay, using the cervical specimen collected with Cytyc's ThinPrep collection technology.

The FDA has granted approval for the OraSure HIV-1 Western Blot Kit, which is used to confirm HIV infection in samples taken orally. Samples are collected on a specially treated pad that is placed by the user between the lower cheek and gum for two minutes. The pad collects oral mucosal transudate, which contains high concentrations of antibody and is free of most of the contaminants found in saliva. OraSure will be available in a few months in physician's office, private and public testing sites, community-based health clinics and AIDS service organizations.

Hoffmann-La Roche, is developing an assay to determine the presence of human papillomavirus (HPV) in a sample can be detected and the HPV typed by a method that involves the amplification of HPV DNA sequences by the polymerase chain reaction (PCR). The primers used in the method are consensus primers that can be used to amplify a particular region of the genome of any HPV. The presence of HPV in a sample is indicated by the formation of amplified DNA. The HPV nucleic acid is detected by consensus probes that may be short oligonucleotide probes or long generic probes. The HPV is typed by the use of type-specific DNA probes specific for the amplified region of DNA.

Immucor, Edmonton, Inc. has received permission from the Medical Devices Bureau of Canada to market their ABS2000, an automated analyzer for the blood bank laboratory. The ABS2000 is the first fully automated, or "walk-away," medical laboratory analyzer to perform the routine blood transfusion compatibility tests currently done manually by blood bank technologists.

Johnson & Johnson Clinical Diagnostics, is developing a slide test element and method of assay that allows for detection of analytes in biological liquids without the use of any detection reagents. The method uses NIR spectroscopy and a test element comprising a support, and a substantially constant light-path defining layer comprising a diffusely-reflecting material that is a) sufficiently porous in all directions as to allow a liquid to spread uniformly in all directions, and b) homogeneously reflects at least 95% of NIR radiation.

Cortecs International, London, UK announced that it has entered into an agreement with Osteometer Biotech A/S and with the Centre for Clinical and Basic Research for the clinical development of an oral formulation of insulin for the management of diabetes mellitus. Under the agreement, Osteometer and CCBR will, in return for a royalty on sales, organize and execute at their own cost the clinical test of oral insulin to generate the clinical data required for registration applications in Europe.

Assist Technologies, Phoenix, AZ announced the release of the Outcomes Analyzer, a software package designed to quickly and inexpensively help healthcare providers identify which treatments and physicians provide the best outcomes from the patients' point of view. The Outcomes Analyzer provides thousands of possible views of outcome data in colorful, easy to read graphs. Outcomes can be analyzed by disease, procedure, physician, intervention, age group, payer and co-morbid condition. It helps to identify which physicians have sicker patients before and after treatment; identify which patients are likely to be hospitalized within a set time, or experience job loss, depression, or mortality; evaluate specific individual dimensions of health over time; and address parameters sought by payers or employers. Additional information such as population norms, disease norms and confidence intervals can be added at the click of a button.

Roche Molecular Systems (RMS), has received FDA approval for their AMPLICOR HIV-1 MONITOR Test that measures quantities of HIV-1 RNA in the blood (viral "load"), using polymerase chain reaction (PCR) technology. Test quantitates viral loads at levels as low as 400 HIV RNA copies/mL, as compared to other tests which are unable to detect HIV RNA levels lower than 10,000 copies per mL. The test quantitates the amount of virus in a sample by comparison to a reference standard containing a known quantity of synthetic RNA that is added to each specimen. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. The company also announced the launch of its AMPLICOR ACCESS PROGRAM, which will offer two free HIV RNA baseline tests to all HIV- positive patients in the United States for 60 days, starting June 17.

Hemagen Diagnostics and Sheffield Medical Technologies are developing an immunoassay test designed to identify long-term non-progressors with HIV infection. The test is based on the discovery of an antibody by French virologist Dr. Jean-Claude Chermann, Marseille, France, and detects an antibody to a cryptic epitope on beta-2 microglobulin (B2M), a common protein on the surface of many human cells. The epitope is exposed whenever the protein is found on HIV, regardless of viral mutation or HIV strain, and the antibody, which neutralizes HIV in vitro, is present in almost all HIV-positive individuals classified as long-term non-progressors.

Xillix Technologies, Richmond, BC, has announced the FDA has voted unanimously in favor of recommending a Pre-Market Approval (PMA) application with two conditions to distribute the Xillix LIFE-Lung system in the U.S. Xillix LIFE-Lung assists physicians in localizing lung cancer earlier in patients with known or suspected cancer. Results from a multi-center clinical trial indicated a 171 percent improvement in the physician's ability to identify and locate suspicious tissue using Xillix LIFE-Lung as an adjunct to white light bronchoscopy, versus conventional white light bronchoscopy alone.

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