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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 1996

Abbott Laboratories and SpectRx, Inc., have signed a research and development and license agreement for a new painless, bloodless technology for monitoring glucose. The glucose monitoring system being developed by SpectRx uses a proprietary technology to painlessly create a tiny micropore in the outer, dead layer of skin through which pure Interstitial Fluid (ISF) is collected and glucose level readings are made. In-house clinical studies conducted by SpectRx show that the glucose in pure ISF can be measured with existing, off-the-shelf glucose test strip chemistry.

bioMerieux Vitek, and Affymetrix, Inc. have signed a collaboration agreement to develop DNA probe arrays using Affymetrix GeneChip technology. bioMerieux will use Affymetrix' GeneChip technology for the development of its new probe-based microbiology and antibiotic resistance clinical diagnostic system.

Hoffmann-La Roche and Affymetrix, have signed an agreement under which Roche will use the Affymetrix GeneChip technology to monitor gene expression. Affymetrix will supply Roche with GeneChip instruments and custom DNA probe arrays containing H. influenza and S. pneumonia genes selected by Roche. Roche will evaluate the ability of the DNA probe arrays to quantitatively detect differences in bacterial gene expression.

Affymetrix, Inc. has entered into an agreement with Merck & Co., Inc., under which Merck will use the Affymetrix GeneChip technology to quantitatively monitor the expression of human genes. Affymetrix will supply Merck with GeneChip instruments and custom DNA probe arrays containing genes selected by Merck. Merck will evaluate the ability of the Affymetrix DNA probe arrays to quantitatively detect differences in gene expression.

Nymox Pharmaceutical, Montreal has successfully completed several large clinical trials and has currently assembled an international panel of expert consultants who have begun to draft the FDA submission documents for their AD7C, Alzheimer's test. The test performs as well as an autopsy in ruling out Alzheimer's disease and should become the gold standard as the only reliable biochemical measurement for the disease, it is also a major step forward in the effort to find a drug that will stop the disease.

Boehringer Mannheim is launching the AccuStart H. pylori Education Program to provide information on H. pylori, including diagnosis and treatment options. The program is aimed at both physicians and ulcer patients. Boehringer Mannheim licensed the AccuStart H. pylori Rapid Assay from Cortecs International and now markets the test to physicians with an information package.

Cambridge Biotech Corporation, Worcester, Mass has been bought by bioMerieux Vitek, Inc., for $5.85 million in net cash. As a wholly-owned subsidiary of bioMerieux, CBC will continue to operate its retroviral diagnostic business which focuses on the development, manufacture and sale of diagnostic kits for use in the diagnosis of diseases caused by retroviruses.

Chiron Diagnostics has received U.S. FDA clearance to market ACS:Dpd, an automated bone resorption immunoassay based on Metra Biosystems' Pyrilinks-D technology. Designed for use on the ACS:180 automated immunoassay system, the ACS:Dpd assay provides quantitative measure of the urinary excretion of deoxypyridinoline (DpD) crosslinks, an accepted marker of bone resorption (loss).

Ciba Corning Diagnostics Corp. has announced a name change to Chiron Diagnostics Corp., effective Nov. 1, 1996.

American Association of Pharmaceutical Scientists' researcher, Salim Farah, has developed a new non-invasive cholesterol test that uses water-soluble drops on the skin to provide cholesterol level readings. Research has shown that cholesterol bound to the skin can provide information as useful as blood cholesterol. Skin cholesterol is less prone to fluctuation after food ingestion when compared to blood cholesterol. Clinical trials in the general population are set to start soon.

Cytyc Corporation has submitted a FDA, Premarket Approval Application to allow patients with inconclusive or borderline diagnoses of cancerous cells to be tested for HPV directly from the single cervical sample collected to prepare Cytyc's ThinPrep Pap Test.

Dade International has signed a five-year development and distribution agreement with Cardiovascular Diagnostics Inc. in point-of-care hemostasis testing. Dade will distribute Cardiovascular's Thrombolytic Assessment System (TAS) for the arrest of bleeding to hospital and non-hospital laboratories.

Diametrics Medical, Inc. has launched the new IRMARSL, its second generation of the IRMAR bedside blood analyzer. IRMARSL offers an expanded test menu that includes testing capability for blood gases, electrolytes and now features hematocrit testing, as well as new features such as electronic quality control and enhanced patient information options.

Digene Corporation and Cytyc Corporation have formed an alliance that combine Digene's Hybrid Capture Assay DNA probe tests and Cytyc's ThinPrep specimen collection and preparation technology. They intend to create, develop, and market products for identifying and managing cervical cancer and other sexually transmitted diseases.

Diagnostic Products Corp. has received clearance from the U.S. FDA to market 61 new allergy diagnostic assays. The 61 new assays follow the clearance of 57 allergy diagnostic tests in January of this year and add to DPC's extensive menu of available assays for the AlaSTAT automated test system.

Cell Robotics International, Albuquerque, NM has received approval from the US FDA for clinical testing of Lasette laser finger perforator. The Lasette is used for sampling capillary blood for glucose and other blood chemistry readings.

Gamma Biologicals, Houston, TX. has submitted a 510K application to the FDA for approval to market the Gamma-ReACT(TM) Test System, a microcolumn gel technology designed for the rapid detection of red blood cell antibodies. The ReACT system consists of a centrifuge, an incubator and a plastic strip containing an immunoreactive agarose. The disposable strip is a microcolumn panel of six or eight different tests.

OncorMed, Inc. and Affymetrix, Inc. have signed an agreement to collaborate in the development and clinical validation of genetic testing services using the Affymetrix GeneChip system for analysis of genes associated with cancer. The project will begin with the p53 gene and include genes involved with breast, colon, ovarian and other cancers.

Genzyme Corp. has begun marketing its N-geneous HDL cholesterol test in the United States. The test is manufactured by Daiichi Pure Chemicals Co., Ltd., Tokyo, and measures how much high-density lipoprotein cholesterol is present in a patient's serum. It is simpler than other HDL cholesterol tests currently on the market because it eliminates the need to pretreat patient samples manually. N-geneous HDL can be conducted completely on an automated clinical chemistry analyzer.

American Biogenetic Sciences, Copiague, NY has receives FDA clearance for its patented Thrombus Precursor Protein (TpP) diagnostic test that measures the risk assessment of blood clot formation (thrombosis) and to monitor anticoagulant therapy. The test measures soluble fibrin polymers which have been shown to be elevated in patients at risk of thrombosis. ABS has licensed the TpP test to Abbott Laboratories and Hoffmann-La Roche for use on their proprietary automated diagnostic systems.

Meridian Diagnostics, Cincinnati, Ohio, has filed a patent application for an immunoassay for H. pylori in fecal specimens. The Company plans to apply for F.D.A. clearance to market within this fiscal year.

Instrumentation Laboratory has launched an initial public offering (IPO) of 5,364,889 American Depositary Shares ("ADS"), each representing one Ordinary Share of the Company. The initial public offering price was $12.00 per share. The shares will be traded on the Nasdaq National Market under the symbol "ILABY." The net proceeds from the offering and the concurrent sales will be used to repay outstanding indebtedness.

Immucor has begun clinical trials for its second automated blood analyzer, the ABS(HV). Immucor's leading instrument, the ABS2000, which was submitted previously to FDA and is awaiting U.S. market clearance. The ABS(HV) is designed to perform certain blood compatibility tests currently done manually by blood bank laboratory technologists. Both the ABS2000 and the ABS(HV) utilize the company's patented and proprietary Capture reagent technology.

INCSTAR has received 510(k) clearance notice to market its 25-OH-D RIA assay, the first test method on the market to be cleared by the FDA for the detection of 25-Hydroxyvitamin D (25-OH-D) in blood. 25-OH-D is the predominant circulating form of vitamin D in the normal population, and as such, is considered to be the most reliable index of an individual's vitamin D nutritional status.

KDK Corporation, Tokyo has begun selling, the HA-8150, a rapid glyco-hemoglobin measuring device for use in the diagnosis and treatment of diabetes, in Japan. The device's processing speed has been reduced from the conventional three minutes to 1.9 minutes.

Matritech, Newton, Mass has begun clinical trials of its nuclear matrix protein immunoassay for colorectal cancer. Research has shown the NMP based colorectal cancer test is more than twice as sensitive as the carcinoembryonic antigen assay (CEA) in identifying colorectal cancer, Meretek, Seattle, WA, has received FDA market approval for its MERETEK UBT Breath Test For H. Pylori. The new breath test is the first non-invasive, non-radioactive diagnostic test of any kind to directly detect the presence or absence of active H. pylori.

Twenty First Century Health, Las Vegas has acquired the exclusive North American rights of a patented noninvasive diabetes blood test and instrument to measure Hemoglobin A1C. The current version of this revolutionary device is 8 x 4 x 2 inches, battery powered, and easy to operate. The selling price of the device will be $500 to $800. The unit allows individuals to put a finger on the base and within seconds see the A1C reading from the digital readout. The new technology, which has been tested on both human subjects and whole blood samples, uses a patented radio frequency spectroscopy of multiple wave forms. TFCH is expecting further news on a Non-Invasive Glucometer which is in its later testing phase.

QUIDEL has received CLIA waived status for its QuickVue One-Step H. Pylori Test. The QuickVue product is the first H. pylori test to receive such categorization from the Centers for Disease Control and Prevention (CDC).

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* Product developments - September 1996
* Product developments - August 1996
* Product developments - July 1996
* Product developments - June 1996

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Last modified: November 03, 1996