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.

American Biogenetic Sciences, Boston, Mass has received 510(k) clearance from the Food and Drug Administration to market its patented Functional Intact Fibrinogen (FiF) test for the quantitative determination of fibrinogen in human plasma. The FiF product is cleared for use as "a fibrinogen determination test for the testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coagulation, cardiovascular disease and primary fibrinolysis." Recent research papers have reported that the fibrinogen level is an independent risk factor of cardiovascular disease. It has been reported that an individual with normal cholesterol and elevated fibrinogen levels may be at risk for myocardial infarction, stroke or other thrombotic disorders.

Becton Dickinson and Company, Franklin Lakes, NJ, has completed the previously announced acquisition of Difco Laboratories Incorporated, a manufacturer of microbiology media and supplies. Becton Dickinson said the acquisition of Difco will broaden the product array of its microbiology business, Becton Dickinson Microbiology Systems (BDMS).

Beckman Instruments, Brea, CA, has introduced the IMMAGE system, a fully-automated immunochemistry system that functions both as a high-speed protein analyzer and a random-access TDM analyzer. Beckman's rate nephelometry serves as one detection system for the analysis of protein and drug analytes. The second detection system, near-infrared particle immunoassay (NIPIA), increases the analytical sensitivity nearly a thousand-fold to address lower molecular weight analytes, such as digoxin, ferritin, myoglobin, and tumor markers, including alpha-fetoprotein (AFP) and carcinoembryonic antigen (CEA). When combined with the streamlined design and operation of the system's reaction wheel, the IMMAGE system's throughput reaches up to 180 tests per hour.

Centocor, Inc., Malvern, PA, has received clearance from the U.S. Food and Drug Administration to market its CA 15-3 serum tumor marker radioimmunoassay. The CA 15-3 RIA, when used in conjunction with other clinical and diagnostic methods, is a valuable adjunct in the overall management of breast cancer patients. Developed and brought to market in other countries by Centocor since 1985, the CA 15-3 RIA is now available for use in the U.S. Through a distribution agreement with Fisher Scientific, Houston, Texas, the CA 15-3 RIA is being launched to clinical laboratories nationwide. The CA 15-3 RIA serum tumor marker assay is one of the most extensively studied and widely used tumor marker tests in the world and is the subject of more than 200 peer-reviewed, published clinical studies. Centocor estimates that the market for this product in the U.S. is nearly $15 million.

Cygnus, Inc., Redwood City, CA has announced that Becton Dickinson and Company has elected to broaden its collaboration with Cygnus by agreeing to fund, in part, the development of a second generation GlucoWatch, a non-invasive glucose monitoring device. In February 1996, Cygnus announced it had signed an agreement with Becton Dickinson for the marketing and distribution of the first generation GlucoWatch. GlucoWatch is currently in development and it is anticipated that pivotal clinical trials will commence in the next several months.

Genelabs Diagnostics SA, Geneva, Switzerland, has appointed Murex Diagnostics Corporation to handle distribution of its diagnostics products in Europe and South America. The agreement provides for the sale of viral confirmatory tests including, Western Blots for HTLV, HIV, EBV and CMB, Autoblot 36 and Western Blot instrumentation, as well as Hepatitis E Elisa.

Hemagen Diagnostics Inc., Waltham, Mass has obtained FDA clearance to market the VIRGO Anti-mitochondrial Antibody (AMA) kit to screen patients for primary biliary cirrhosis, a disfunction of the liver. AMA is an important addition to Hemagen's growing line of autoimmune detection products. Mitochondrial antibody is of particular interest because it has been found in most patients (approximately 90 percent) with primary biliary cirrhosis. There is increasing evidence which indicates that three chronic liver syndromes (primary biliary cirrhosis, chronic active hepatitis and cryptogenic cirrhosis) represent expression of an underlying process closely associated with the autoimmune phenomena.

Hycor Biomedical Inc., Irvine, CA, has received clearance from the U.S. Food and Drug Administration to market its Latex Allergy Test.

Direct Access Diagnostics, (a J & J company) Bridgewater, NJ today announced that its CONFIDE HIV Testing and Counseling Service is being withdrawn from the market, effective immediately, due to lack of consumer demand. CONFIDE was cleared for marketing by the U.S. FDA on May 14, 1996.

LXR Biotechnology, Richmond, CA, is developing a new technology for the detection of DNA in urine. With this technology, it may be possible to determine the sex of a fetus in a pregnant woman as early as six weeks after conception. In addition, it may have application in cancer detection and diagnosis. This proprietary technology is based on the discovery that DNA appears to penetrate the placental and kidney barriers and can be detected in urine. As a fetus develops, certain cells die from apoptosis as a part of normal development causing fetal DNA to be shed into the mother's bloodstream. This fetal DNA ultimately ends up in the mother's urine and can be detected by various methods. Detection of DNA that is uniquely associated with the male Y chromosome would indicate that the fetus was male. "We have been looking for markers of apoptosis through simple blood or urine tests for several years and now have established proof of concept in human studies," said Dr. L. David Tomei, chief executive officer of LXR.

Mosaic Technologies Inc., Boston, Mass has been issued a US patent for its invention of the Bridge amplification process, a novel solid-phase application of the conventional liquid-phase PCR technology. Mosaic's Bridge technology provides the basis for developing reagent and photonic platforms that can automate PCR. Mosaic's Bridge technology enables PCR tests to be run on a solid phase instead of in solution, permitting simultaneous multiple assessment of different viruses and bacteria.

Researchers from Helsinki University Central Hospital, Finland, have developed a urinary dipstick test that may make it easier and more feasible to screen patients for pancreatitis who are admitted to the emergency department with abdominal pain. The test measures urinary trypsinogen-2 concentrations, which are elevated in patients with pancreatitis.

Source: New England Journal of Medicine, 1997;336, June 19, 1997:1788-1793.

Simplex Medical Systems, Inc., Hallendale, Fla, have completed phase one of clinical studies of the Simplex Rapid HIV Saliva Test that detects HIV-1 and HIV-2 antibodies in a patients' saliva. The clinical studies have shown a 99% correlation with the most sensitive ELISA (Enzyme- Linked-Immunosorbent-Assay) clinical assay available.

Technical Chemicals & Products, Inc., Pompano Beach, Fla, will be collaborating with SmithKline Beecham in the development of TCPI's TD Glucose Monitoring System, a non-invasive glucose monitoring product for diabetics. This exclusive agreement grants SmithKline Beecham a six month period in which to evaluate the TD Glucose technology and negotiate a definitive licensing agreement for the worldwide marketing of TCPI's device. The TD Glucose Monitoring System uses disposable transdermal patch sampling technologies and a small hand-held monitoring reflectance meter, both developed by TCPI, to measure glucose levels.

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