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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 October 2000

Abbott Labs and the Collaborative Group, Ltd. have signed a worldwide, exclusive license agreement granting Abbott access to Collaborative's technology relating to fungal beta (1,3)-glucan detection reagents for human fungal diagnostic assay development and commercialization.

Aethlon Medical, Inc. is developing HIV Hemopurifier technology an extracorpeal therapeutic cartridge designed to physically remove the HIV virus and potentially other toxic viral products from the blood. Aethlon plans to petition the FDA to begin human trials of the HIV Hemopurifier within the next year.

Affymetrix is buying Neomorphic Inc., a computational genomics company, for about 1.4 million shares. Affymetrix expects to develop whole genome, high-density GeneChip arrays, new data analysis tools and a series of internet-accessible information products as a result of the acquisition.

Bartels, a subsidiary of Intracel, has received FDA approval to market its Legionella Urinary Antigen (LUA) ELISA Test as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease by qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine.

Bayer Diagnostics has received FDA clearance to market its complexed prostate specific antigen (cPSA) test on the Bayer Immuno1 instrument. Bayer offers FDA cleared manual and automated tests for PSA and complexed PSA.

Beckman Coulter, Inc. has received FDA clearance to market to market a urine drug test for the detection of ecstasy and other amphetamines using the SYNCHRON CX or LX clinical chemistry systems. The test can detect 2.5 micrograms of the drug per mL of urine.

Bio-Rad Laboratories, Inc. has received from Quest Diagnostics Incorporated the exclusive licensing rights to Bio-Rad's patent portfolio relating to hereditary hemochromatosis. Under the agreement, Bio-Rad acquires the right to grant additional licenses for tests relating to the hemochromatosis gene (HFE), including specific mutations G845A (C282Y) and C187G (H63D), and procedures for using molecular markers to detect the presence or absence of hereditary hemochromatosis. Quest Diagnostics acquired its rights when it purchased SmithKline Beecham Clinical Laboratories (SBCL) in August 1999.

Cerus Corporation and Baxter Healthcare Corporation have begun a Phase 1c clinical trial of the Intercept Red Blood Cell System, a proprietary system to inactivate viruses, bacteria and other pathogens in red blood cells platelets and plasma intended for transfusion.

Chiron Corporation and F. Hoffman-La Roche have signed a patent license agreement for probe-based clinical diagnostics for the HCV and HIV-1. The license agreement in clinical diagnostics allows for settlement of pending litigation in the United States and six other major markets and will enable Roche to continue to market probe-based HCV and HIV diagnostic products, including its PCR tests, for these viruses. Chiron will also grant a limited license to Roche under its HCV and HIV intellectual property for nucleic acid testing (NAT) of blood intended for transfusion. Major licensees of Chiron's HCV technology include Abbott Laboratories, Bayer AG, Ortho Clinical Diagnostics (a Johnson & Johnson company), BioRad Laboratories and Gen-Probe Incorporated for diagnostics, and Pharmacia, Glaxo Wellcome and others for therapeutic applications.

Cytyc Corporation and Roche Diagnostics Corporation an agreement valid in the US to co-market Roche's PCR based screening and diagnostic tests to be performed from Cytyc's ThinPrep Pap Test collection vial. The first tests to be submitted to the FDA will be assays for Chlamydia trachomatis and Neisseria gonorrhea testing directly from the ThinPrep vial using Roche's COBAS AMPLICOR system.

Consorta Catholic Resource Partners has signed a five-year, $150 million contract under which Dade Behring and two of its business partners, Diagnostics Products Corporation and Olympus Corporation that will provide Consorta's members with a full spectrum of chemistry, immunochemistry and related reagent products. The deal includes the Dimension RxL chemistry system with DPC's IMMULITE product and Olympus's instrumentation.

Dynamic Healthcare Technologies Inc. and InterScope Technologies Inc. have agreed to co-develop a pathology workflow and microscopic imaging platform. Dynamic will integrate InterScope's Abintra image capture and archive functions into its CoPath and CoMed products - allowing patient information, pathology orders, results and images to flow between the systems.

Hemagen Diagnostics Inc. has an agreement with Quest Diagnostics Inc. to provide various autoimmune and infectious disease kits. The agreement includes seven products in fourteen formats manufactured by Hemagen, including tests for sexually transmitted diseases, and other infectious diseases.

InMedica Development Corporation has licensed its patented non-invasive hematocrit technology, CritTrend to Wantagh, Inc. Wantagh plans to incorporate the technology into future versions of their FDA approved medical device, the IQ System, for measuring real time non-invasive comprehensive hemodynamics.

Inverness Medical Technology, Inc. and Integ, Inc. have signed an agreement to merge Integ into a subsidiary of Inverness Medical Technology.

Ixion Biotechnology has received a $100,000 Phase I SBIR grant from the National Institute of Diabetes and Digestive and Kidney Diseases to develop a test for Oxalobacter formigenes. O. formigenes is an anaerobic bacterium that lives in the intestinal tracts of humans. Reports show a direct relationship between the absence of O. formigenes and enteric hyperoxaluria and idiopathic recurrent calcium-oxalate stone disease.

Kumetrix, Inc. has received a $100,000 Small Business Innovative Research (SBIR) contract from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) for the development of miniature sensors for continuous monitoring of blood glucose.

Metrika Inc. has received both a CLIA waiver and FDA 510(k) clearance to market its home use DRx HbA1c Patient Monitor -- for long-term glucose monitoring for people with diabetes.

Quantum Dot and SurroMed Inc. have been awarded a $5.6 million grant from the National Institute of Standards and Technology (NIST) under its Advanced Technology Program (ATP) to develop blood fingerprinting and optical detection technologies. The companies are developing a rapid analysis technique of whole blood for cell-surface markers, pathogens, and biologically important soluble factors.

Quidel has received FDA clearance to market its QuickVue rapid flu test in physicians' offices. The test detects influenza types A and B within 10 minutes.

Healthcare Technologies, Ltd. has acquired GamidaGen Ltd., developer of a technological platform for gene based analysis of genetic and infectious diseases. Healthcare plans to merge GamidaGen into its Savyon Diagnostics subsidiary.

SpectRx, Inc. has received a grant of $307,000 from the Centers for Disease Control and Prevention (CDC) to adapt the company's glucose monitoring technology to monitor blood sugar levels of children and elderly people with diabetes. SpectRx, in collaboration with the MediSense Products Unit of Abbott Laboratories, is developing a monitoring technology that provides continuous, painless, real-time and non-invasive glucose readings.

Ventana Medical Systems, Inc. has introduced Benchmark, an automated histology instrument for protein, DNA and RNA testing.
Benchmark automates the steps required in baking, dewaxing, cell conditioning and staining tissue for the purpose of cancer and infectious disease diagnosis. Benchmark will perform immunohistochemistry (IHC) stains, in-situ hybridization (ISH) stains and florescence in situ hybridization (FISH) tests on tissue and cytological patient samples.

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* Product developments - September 2000
* Product developments - July - August 2000
* Product developments - June 2000
* Product developments - May 2000
* Product developments - April 2000
* Product developments - March 2000
* Product developments - Febuary 2000
* Product developments - January 2000
* Product developments - December 1999
* Product developments - November 1999
* Product developments - October 1999
* Product developments - September 1999
* Product developments - August 1999
* Product developments - July 1999
* Product developments - June 1999
* Product developments - May 1999
* Product developments - April 1999
* Product developments - March 1999
* Product developments - Febuary 1999
* Product developments - January 1999
* Product developments - December 1998
* Product developments - November 1998
* Product developments - October 1998
* Product developments - September 1998
* Product developments - August 1998
* Product developments - July 1998
* Product developments - June 1998
* Product developments - May 1998
* Product developments - Avril 1998
* Product developments - March 1998
* Product developments - February 1998
* Product developments - January 1998
* Product developments - July 1997
* Product developments - June 1997
* Product developments - May 1997
* Product developments - April 1997
* 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: November 01, 2000