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.

Abbott Laboratories and Toshiba, Japan are collaborating on the development of biosensor based immunoassay systems. Toshiba has been involved in biosensors for detecting cholesterol level, and together with Abbott will develop an analyzer that allows examination of both biochemicals and the immune system in one machine. Abbot will manufacture the immune examination part of the equipment, while Toshiba will manufacture the biochemical part. The product is to be commercialized in one to two years.

Abbott Laboratories expects to purchase the Fact Plus and Fact Plus One Step consumer pregnancy test brands from Johnson & Johnson. Introduced in 1982, the Fact Plus products have grown to be one of the leading brands of over-the counter pregnancy tests. The products, which employ a technology developed by Abbott and licensed to Johnson & Johnson, are distinguished by an easy to understand plus/minus readout. The worldwide consumer testing market is growing at a rate of 10 percent. After blood glucose monitoring, consumer pregnancy is the largest consumer diagnostic test category. In 1997, Abbott launched the Signify and Advisor home pregnancy tests to international markets.

Affymetrix, Palo Alto, CA has launched its GeneChip p53 assay for research applications. The GeneChip p53 assay is the first commercially available DNA probe array-based product capable of analyzing the full-length coding sequence of the human p53 tumor suppresser gene, a gene that is mutated in greater than 50% of all human cancers. This product is the second commercially available GeneChip mutation detection assay using the company's proprietary GeneChip system. The GeneChip system consists of disposable DNA probe arrays containing gene sequences on a chip, instruments to process the probe arrays including the Hewlett-Packard GeneArray scanner, and software to analyze and manage genetic information.

AMDL, Tustin, CA, has filed for patent protection for a tumor marker immunoassay, Oncochek. The assay uses a monoclonal antibody to an octopeptide, and a polyclonal antibody to measure the level of fibrinogen degradation products in the serum of a cancer patient. FDP level in cancer patients is elevated due to an increased secretion of protein degrading enzymes by the tumor cells. Preliminary findings indicate that FDP levels in serum of cancer patients are elevated. Such findings are consistent with the widely accepted finding that growing tumors have an increased rate of protease release.

Applied Imaging Corp, Santa Clara, CA, has submitted a 510(k) premarket notification to the US FDA for its Fetal Hemoglobin Identification kit. This kit is designed to identify red blood cells containing fetal hemoglobin and to differentiate them from other red blood cells.

Behring Diagnostics has developed a one-step urine test for drugs-of-abuse testing, the Syva RapidTest, that allows simultaneous multi-drug or individual drug screening with easy-to-read results in only five minutes. The Syva RapidTest assay offers multiple and single tests for cocaine, THC (marijuana), methamphetamine, opiates, amphetamines, phencyclidine, barbiturates, benzodiazepines, methadone, and tricyclic antidepressants. The device will be available shortly in Scandinavia, Spain, the United Kingdom, and the United States, and is expected to be launched in additional countries over the next 6 months.

Biex, Dublin, CA has submitted a pre-market approval application to the US FDA for its SalEst system as a new method for identifying pregnant women at risk for preterm labor and delivery. The test is based on research that elevated levels of estriol in saliva are an early warning sign that preterm labor and delivery may occur within 2 to 3 weeks. The research indicates that women who have elevated levels of salivary estriol are over six times more likely to develop preterm labor and delivery.

Diametrics Medical, St. Paul, MN has introduced a new combination test cartridge for the IRMA SL Blood Analysis System that can perform all critical blood gas, electrolyte and hematocrit tests. Diametrics has also contracted with LifeScan to add the LifeScan glucose to the IRMA system.

Geron Corp, Menlo Park, CA and PharMingen, a wholly owned subsidiary of Becton Dickinson and Company have introduced TeloQuant a proprietary telomere length measurement assay to be marketed by PharMingen under license from Geron. Telomeres, repeated DNA sequences at the ends of chromosomes stabilize the chromosomes, protecting against degradation and fusion with other chromosomes. When a normal cell divides, however, telomere segments are lost. Once the telomeres reach a critically short length, the cell stops dividing and becomes senescent. Telomeres therefore serve as a marker of cell aging. TeloQuant measures chromosomal telomere length.

Gull Laboratories, Salt Lake City, UT, has been issued a US patent for its GeneSTAR system that uses DNA-based technology for the simultaneous detection of multiple disease-causing agents in patient specimens. With GeneSTAR patented technology, clinical laboratories will be able to identify several different contagious organisms in a single test procedure. A patent application for XTRAX, the sample preparation component of the GeneSTAR system, was approved in December 1996. Clinical studies on the full system will begin soon in selected European clinical sites. The first commercial application of the GeneSTAR technology is focused on infectious diseases in fecal samples. The first complete automated test system, slated for U.S. clinical evaluation in 1997, will detect any or all of five different gastrointestinal (GI) pathogens. Total time required from sample preparation to test result is less than four hours, while current bacteria culturing methods may require 18 hours to two weeks.

Hycor Biomedical, Irvine CA, has acquired Cogent Diagnostics, Edinburgh, Scotland, for approximately $3 million in cash and notes. Cogent develops, manufactures and markets a broad line of test kits for the diagnosis of autoimmune disease. Cogent markets 28 different tests for most of the clinically relevant markers for autoimmune disease. The adaptation of the Cogent products to Hycor's new HY-TEC 288 Automated EIA System, is scheduled for release in late fourth quarter 1997.

QUIDEL Corp., San Diego, CA and Innovative Biotechnologies, Niagara Falls, NY are developing disposable chip-based diagnostic tests. The hoped-for result is a series of rapid doctors' office tests that will equal -- if not exceed -- the sensitivity of tests performed on large laboratory-based systems, said Steven T. Frankel, QUIDEL's president and chief executive officer. Studies to confirm the feasibility of the product concept, now underway in labs at Cornell University, are aimed at integrating a series of technologies owned or controlled by the two companies. The combined technologies employ microfabricated interdigitated arrays (IDAs) of ultramicroelectrodes on a microchip allowing for the ultrasensitive detection of single or multiple analytes.

Selfcare, Waltham, Mass, has received FDA clearance for Selfcare's new electrochemical blood glucose monitoring system to be marketed by LifeScan, Inc., a subsidiary of Johnson & Johnson under distribution agreements signed in 1996. Shipment of the New System is expected late in the 3rd quarter 1997.

Shield Diagnostics, has acquired the TTP Corp. division of International Murex Technologies, Toronto, Ontario. TTP Corp. owns the rights to 10 products for diagnosis of thyroid dysfunction, cardiovascular diseases and blood coagulation. Murex will continue to manufacture and market the assays for the next 3 years.

Trinity Biotech, Dublin, Ireland, has signed an agreement with Centocor, in which it obtained rights to develop, manufacture, market and distribute enzyme immunoassay and rapid tests based on Centocor's serum tumor markers. The financial terms of the agreement were not disclosed. Additionally, it completed its acquisition of Centocor's UK infectious disease business. Trinity will develop both rapid and laboratory EIA tests including CA15-3, CA125, CA19-9, CA72-4 and free and total PSA.

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Product developments - June 1996