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.

Americare Health Scan Inc. is developing a saliva-based HIV test, the Ana-Sal saliva test kit. The company has not yet applied for approval from the U.S. FDA, and is planning to in the near future. The Ana-Sal HIV test has been approved for use in a number of other countries.

Applied Imaging Corp has introduced its new MDS Micrometastasis Detection System, for the automated microscopic scanning of samples to detect rare metastatic cancer cells that may be present in the lymph nodes and bone marrow of patients at the time of their initial diagnosis with cancer or following treatment. Micrometastasis is the spread of cancer away from the primary tumor that is not otherwise detectable by conventional screening tests. The MDS is capable of simultaneously scanning in brightfield and fluorescent modes.

AutoCyte has received FDA clearance to market its AutoCyte PREP System for use in primary screening for cervical cancer. PREP is AutoCyte's liquid-based thin-layer sample preparation system that automatically prepares and stains cytology slides. PREP is designed to replace the conventional Pap smear with a preparation that is cleaner, more uniform and easier to interpret.

In addition, AutoCyte announced on June 7 that it has agreed to merge with NeoPath, Inc. in a tax-free stock exchange. AutoCyte and NeoPath are currently conducting a joint clinical trial for the screening of PREP slides by NeoPath's AutoPap Primary Screening System. This supplement is expected to be submitted to the FDA in the second half of 1999.

BioMerieux has received FDA clearance to market its antibiotic susceptibility testing on the VITEK 2, the company's next generation identification/susceptibility test system. VITEK 2 is designed to allow clinical laboratories to identify gram positive cocci and gram negative bacilli quickly and accurately and assess their resistance.

Bio-Rad Laboratories has obtained exclusive worldwide rights to market Axis-Shield's activated factor XII (AFT) test in its microplate enzyme immunoassay (EIA) format and on certain future Bio-Rad platforms. Axis-Shield will also adapt the AFT assay for addition to the portfolio of EIA test kits available from Bio-Rad for the CODA microplate analyzer. Axis-Shield's novel, patented AFT assay specifically distinguishes between non-activated and activated Factor XII to measure levels of AFT in the blood.

Bio-Rad Laboratories announced that it has made an offer to purchase Pasteur Sanofi Diagnostics for approximately $210 million in total compensation. The offer is subject to negotiation of definitive agreements, government approvals and standard conditions as well as to the procurement of committed outside financing. While PSD's shareholders have not yet agreed to the offer, they have agreed to negotiate exclusively with Bio-Rad on the basis of Bio-Rad's offer for a limited period of time.

Cepheid has introduced GeneXpert, a bench-top DNA detection system that can process up to 5 mL of urine and determine the presence of chlamydia and gonorrhea in less than 30 minutes. GeneXpert is based on the company's proprietary DNA-based microfluidics technology contained within a completely self-contained disposable cartridge.

Genua 1944 I Inc. has introduced the Genua Menopause Monitoring Kit, a home test kit to determine menopause based on the urinary concentration of the FSH. The product has been approved for sale by both the Canadian Health Protection Branch and the U.S. FDA.

Hewlett-Packard Company and Diametrics Medical have signed a 3 year agreement giving HP exclusive worldwide rights to market, sell and distribute Diametrics' Paratrend and Neotrend continuous blood-gas monitoring systems and the IRMA SL point-of-care blood-testing system. Diametrics will transfer full responsibility for marketing, sales and distribution for these products to HP by Nov. 1, 1999.

Lifestream Technologies has submitted a 510(k) pre-market notification to the US Food and Drug Administration for its Privalink software accessory, that combines its Cholesterol Monitor and patient information through the internet using industry-standard Smart Cards and high-level encryption. The Privalink System enables healthcare professionals to perform a total cholesterol test, add additional patient health information, perform health risk analysis with the Lifestream Technologies Cholesterol Monitor, and then return a personalized patient evaluation booklet through the internet in less than 10 minutes.

Nymox Pharmaceutical Corporation has developed a new urine test for Alzheimer's disease. The new Nymox 7C Gold test is designed for use in the doctor's office or in the clinical lab setting. The Company has not yet announced projected dates for introduction of the new test to the market, but it is expected to be available for sale in many parts of the world in 1999. The test was developed in collaboration with Serex Inc. (Maywood, New Jersey).

QUIDEL Corporation has acquired Metra Biosystems, Inc. for $22.9 million. Metra Biosystems has distribution agreements and strategic collaborations with major diagnostic and pharmaceutical companies including Abbott Laboratories, Beckman-Coulter, Inc., Bayer Corporation, Diagnostic Products Corporation, and Sumitomo Pharmaceuticals.

Sybron International has acquired Microgenics Corporation. Microgenics manufactures reagents for use in drugs of abuse screening, therapeutic drug monitoring, thyroid function testing and anemia testing. Microgenics' annual sales are approximately $35 million. Microgenics joins the Sybron family which includes Diagnostic Reagents, Inc. and Seradyn.

Ventana Medical Systems, Inc. has introduced the NexES system, a new module for its NexES system that will automate in-situ hybridization testing of tissue or cells mounted on microscope slides. The NexES system was launched in late 1997 with immunohistochemistry staining capability only and special staining capability was added in late 1998. The ISH module will be offered at a price of $85,000 with an initial menu that includes tests for Her-2/neu gene amplification, human papillomavirus, cytomegalovirus, Epstein Barr virus, Kappa and Lambda.

ViroLogic, Inc. has launched PhenoSense HIV, a rapid phenotypic HIV drug resistance assay. PhenoSense HIV directly measures the sensitivity or resistance of a patient's virus to each of the currently available antiretroviral drugs for HIV in two weeks, rather than the nearly 4-6 weeks for other currently available phenotypic resistance tests.

VWR Scientific Products and Molecular Circuitry, Inc. are developing the DETEX system, an automated pathogen testing system that detects Listeria, Salmonella, E. coli 0157:H7 and Campylobacter, simultaneously. The system uses patented electrochemical detection methods in an automated instrument. The DETEX System is currently in test with some of the largest food processors and retailers in the United States.

Wampole Laboratories, a division of Carter-Wallace, Inc. has launched the PreVue B. burgdorferi Antibody Detection Assay, a rapid test for Lyme disease. The PreVue product is being sold to physician offices and clinical laboratories through a network of authorized distributors. The test provides visually-read color results using serum or whole blood samples, in 20 minutes.

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