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.

AccuMed International has sold its microbiology business to AMI Acquisition Corp., a new venture between Key Equity Capital and Mr. Michael D. Burke, a former AccuMed executive. AccuMed will now focus its resources on research and data gathering to support the cytology product lines.

Intelligent Medical Imaging has granted Bayer Diagnostics license to use for IMI's slide making and staining technology for hematology, the Hematology Slide Master. Bayer plans to utilize the HSM technology to produce an automated slide maker and stainer to complement its ADVIA 120 Hematology System. IMI will supply after market supplies to support Bayer's slide maker and stainer product, and Bayer will co-manufacture IMI's version of the HSM to provide expanded manufacturing capability for IMI.

This month IMI also entered into a distribution agreement with Beckman-Coulter involving IMI's blood slide maker, the Hematology Slide Master (HSM). The non-exclusive distribution agreement has a term of ten years and allows Beckman-Coulter to obtain the HSM on a volume discount basis for re-sale to its customers. Beckman-Coulter plans to offer the HSM primarily at installations involving multiple GenSs, as a total automation alternative involving the integration of a hematology analyzer, automated blood slide maker (HSM) and automated microscopic review (Micro21). The HSM was specifically designed to inter-link with the MICRO21 automated microscopic review system. A MICRO21 can therefore be integrated with a GenS-HSM to provide a totally automated blood analysis process.

The BTA stat test, manufactured by Bion Diagnostic Sciences (formerly Bard Diagnostic Sciences, Inc.) a subsidiary of Polymedco received FDA clearance for home use. The test is now available by prescription for home use to detect recurrent bladder cancer as an aid in the management of bladder cancer patients in conjunction with cystoscopy. The BTA stat test is a single step rapid immunoassay, which requires 5 drops of urine and provides results in 5 minutes.

BioStar, a recently acquired subsidiary of Thermo BioAnalysis Corporation has received FDA clearance to market FLU OIA, its rapid test for influenza that can detect both influenza A and influenza B within 20 minutes. The FLU OIA test was developed in collaboration with Biota Holdings Limited of Australia.

Fujirebio Diagnostics, Inc. (formerly Centocor Diagnostics of Pennsylvania, Inc.) has signed an agreement with Polymedco, Inc. for North American distribution of the company's tumor marker assays -- CA125II, CA19-9, CA15-3, CA72-4, and Cyfra21-1 as well as the Truquant BR and GI Assays.

Sangui BioTech International's subsidiary Gluko MediTech AG is developing a long-term implantable glucose sensor, which is designed to determine the glucose level in the interstitial fluid by means of an opto-electronic measuring device. The sensor is designed to remain inside the diabetic patient for a minimum of three years and to maintain smooth operation during that period. Licensing procedures and the launch of the sensor are expected for 2003/2004.

Home Access Health Corporation has filed a pre-market approval application with the FDA seeking clearance to market an at-home telemedicine counseling and testing service for Hepatitis C. The Home Access Hepatitis C Check(SM) service includes the same operating characteristics as the Home Access HIV test service and combines telephone registration/pre-test counseling, collection of a blood sample, shipping, laboratory testing, telephone results retrieval and post-test counseling.

Instrumentation Laboratory SpA has tendered a bid to acquire Hemoliance, an alliance formed between Medical Laboratory Automation Inc. and Ortho-Clinical Diagnostics to manufacture and distribute coagulation systems. Hemoliance had revenues of approximately $80 million in the fiscal year ended December 31, 1997. The total purchase price is approximately $130 million.

Meridian Diagnostics has received FDA clearance to market the Premier Platinum HpSA (Helicobacter pylori Stool Antigen) test to monitor therapeutic response in patients with H. pylori infection. Premier Platinum HpSA was initially cleared for marketing in May 1998 for diagnosis of H. pylori infection.

Roche Diagnostics has received FDA clearance to market the ONTRAK TESTCUP-er, a drug testing device specifically designed to assess the drugs of abuse status of emergency room patients. ONTRAK TESTCUP-er is capable of simultaneous detection of cocaine, morphine, amphetamines, barbiturates, and benzodiazopene, providing positive or negative results in less than five minutes. The ONTRAK TESTCUP-er device is a self-contained, integrated collection device and drug screening assay.

Shield Diagnostics has launched an enzyme-based assay for homocysteine. Shield's patented test involves four simple steps to give a colour change that can be read in standard colorimetric equipment. Results can be obtained within 30 minutes.

Spectral Diagnostics and Metra Biosystems have signed a definitive agreement to merge the companies. Metra Biosystems markets products for the detection and management of metabolic bone diseases and disorders. Spectral Diagnostics markets point-of-care cardiac marker assays.

Vysis, Inc. has received FDA market clearance for its PathVysion HER-2 DNA Probe Kit to detect and quantify the HER-2 gene in breast cancer patients. Based on Vysis' patented Fluorescence In Situ Hybridization (FISH) technology, the test detects both the HER-2 gene and the chromosome 17 on which the gene resides. In order to accommodate the anticipated demand for the HER-2 test, Vysis is developing an automated instrument to enhance laboratory throughput. FISH assays are currently reimbursable by third-party payers.

VesPro Life Sciences LLC has developed a new at-home free radical urine test kit. VesPro's Free Radical Test can help determine the antioxidant levels that are necessary for the body to help fight free radicals that promote disease and aging. The test will be marketed with its partner product, Ox-Ogenol, an anti-oxidant formulation designed to deliver the precise amount of nutritional therapy indicated by the Free Radical Test results. The Free Radical Test contains four individual tests to be performed weekly over a one-month period.

Product developments - November 1998
Product developments - October 1998
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Product developments - July 1997
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Product developments - December 1996
Product developments - November 1996
Product developments - October 1996
Product developments - September 1996
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Product developments - July 1996
Product developments - June 1996