The following is a review of diagnostic product developments worldwide

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.

Biofield Corp. has developed a non-invasive diagnostic test, based on measuring electropotentials at the skin surface, that has the ability to help discriminate benign lesions from breast cancer. The technique records and analyzes changes in electrical charge distributions associated with the development of breast cancer. The Biofield Diagnostic System is scheduled to be commercially available in Europe by late 1998.

Technical Chemicals & Products and MicroWeiss Electronics have collaborated to form Technical Electronics Corporation that will develop and manufacture electronic measuring devices for TCPI's non-invasive TD Glucose Monitoring System, Total and HDL cholesterol testing meter, and other diagnostic monitoring products being developed by TCPI. The Joint Venture company will initially focus on the cholesterol meter product. Clinical trials related to the TD Glucose Monitoring System are ongoing and anticipated to conclude in the second half of 1998 followed by a filing to the FDA for marketing clearance.

Phytera, Inc. and Eli Lilly and Company have entered into a research collaboration to discover novel agents for the diagnosis, treatment and prevention of infectious fungal diseases. The alliance encompasses human and animal veterinary diagnostics and therapeutics.

Gull Laboratories has begun proceedings to merge with Meridian Diagnostics for a cash consideration of $3.00 per share. Gull markets diagnostic test kits for the detection of infectious diseases and autoimmune disorders, as well as instrumentation for laboratory automation and products for blood grouping and HLA tissue typing for transplantation.

LXN Corp has been awarded a U.S. covering test strips for measuring both glucose and fructosamine in a blood sample from patients with diabetes. Both of these important tests are part of the LXN Duet Glucose Control System a hand held monitor, glucose test strips and fructosamine test strips.

Optical Sensors Inc. is developing a biosensor that perform a simple, non-invasive, under-the- tongue measurement of carbon dioxide in 60 seconds. This measurement can aid in the diagnosis of shock in ill or injured patients, speed treatment, save lives, and significantly reduce cost to healthcare providers.

Haber, Inc. has introduced Electromolecular Propulsion (EMP), a rapid and simple method for analyzing biological stains vital for medical science. Biostains highlight the structural differences between normal and abnormal cells such as cancer. An inconsistency in the stains can significantly contribute to misdiagnosis. EMP technology demonstrates the first realistic method for qualifying the biostains just before use, which are needed for detecting cancer and other diseases by pathologists.

Laboratory Corporation of America Holdings (LabCorp) has introduced Antivirogram and the VircoGEN, two new diagnostic testing procedures to evaluate resistance of HIV to antiretroviral drugs. The tests are available exclusively from LabCorp facilities in the U.S. These new testing systems are an important advance in optimizing treatment choices in the fight against HIV/AIDS. The tests are produced by VIRCO, Belgium.

Intelligent Medical Imaging (IMI) marketer of the MICRO21 System, an automated microscope system has signed a letter of intent with Beckman Coulter giving Beckman a non-exclusive agreement for foreign distribution of the MICRO21.

Bayer Diagnostics and Roche have signed a license agreement granting Bayer non-exclusive, worldwide access to Roche's PCR patents. The license gives Bayer the rights to manufacture and market PCR-based human diagnostic products in the infectious disease, genetics, oncology, tissue typing and therapeutic drug monitoring fields. The financial terms of the agreement are not disclosed.

Trinity Biotech has acquired the Microzyme product line for hormones and drugs of abuse from Diatech Inc. Trinity will pay $1.7 million in cash and loan notes to acquire the product line and approximately $300,000 for associated inventories. The product line had revenues of $1.6 million for the year ended December 31, 1997.

Point of Care Technologies has received US FDA approval to market its Genie Cup integrated screening device for a drugs of abuse six drug panel. The Genie Cup integrates sample collection, testing, transportation and storage in a one step device. After the sample is collected, the donor seals the Genie Cup and a simple turn of the cap transfers a portion of the sample into an isolated testing chamber without operator intervention. The remaining segregated sample is uncontaminated and available for further testing, transportation or storage.

Immucor has received US FDA approval to market the ABS2000 an automated, walk-away instrument for the hospital blood bank transfusion laboratory. There are currently over 20,000 patient test results reported monthly on the ABS2000 placements in Europe and Canada.

Sanofi Diagnostics Pasteur has received US FDA clearance to market a new, improved version of its Genetic Systems rLAV EIA specific test for the detection of antibody to HIV-1 viruses in human serum, plasma, or dried blood specimens. The new test demonstrates a broad reactivity with diverse sub-types of HIV-1, and maintains cross-reactivity with HIV-2.

CompuCyte Corporation has developed the OnCyte technology for near-patient, cell-based diagnostic tests. CompuCyte's tests include, 1) a very early blood test for heart attacks which measures a complex of two types of blood cells, monocytes and platelets, which increases immediately after a heart attack. 2) a rapid test for infections in newborns and infants which measures the expression of a protein called CD11b on certain white blood cells within five minutes of their exposure to bacteria, and 3) a rapid test for bacterial contamination of platelets prior to their transfusion into cardiovascular and cancer patients.

Chiron and Gen-Probe have formed a strategic alliance to develop, manufacture and market nucleic acid probe assay systems for blood screening and certain areas of diagnostics. Under the terms of the agreement, Chiron will market and sell products that utilize Chiron's intellectual property relating to hepatitis C and HIV and Gen-Probe's patented transcription-mediated amplification (TMA), target capture, hybridization protection assay (HPA) and dual kinetic assay (DKA) technologies. Initially the alliance will concentrate its efforts on developing, manufacturing and marketing a combination HIV-1/HCV assay for qualitative screening of the world's blood supply. Currently in evaluation studies, this combination assay is expected to enter worldwide clinical trials in the latter part of this year.

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Product developments - June 1996