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.

Biomira, Edmonton, AB has sold its TRUQUANT blood test kits for the management of breast, ovarian and gastrointestinal cancers to Centocor Diagnostics, Inc., Malvern, PA. The transaction includes providing Centocor with an exclusive license with respect to various antibodies and antigens for in vitro diagnostics purposes, plus the sale of equipment used by Biomira's wholly owned subsidiary in Toronto, Biomira Diagnostics Inc. Transfer of technology will take place over the next seven months and operations at BDI will cease on or before August 28, 1998. Under the terms of the asset purchase, Biomira will receive two payments aggregating US $650,000. In addition, Biomira will receive under the license agreement, minimum royalties of US $5 million, with royalties of US $6 million on the net revenues earned by Centocor on blood test sales, including Centocor's CA15-3 tumor marker. Biomira could also receive, under the asset purchase agreement, an additional US $300,000 in milestone payments. For a period of one year, Centocor Diagnostics assumes the right to purchase the manual format of Biomira's STn Response Assay that measures anti-STn antibody in the blood.

Anergen, Inc., Redwood City, CA, has been awarded U.S. Patent no. 5,750,356 by the U.S. Patent and Trademark Office for a modified ELISPOT (ELISA SPOT) assay, designed to enable detection of T-cells that react to the presence of disease associated antigens, which contribute to the onset of chronic conditions such as multiple sclerosis, rheumatoid arthritis and Type I juvenile onset diabetes. ELISPOT combines T-cell cloning and ELISA techniques with a combination of videography and computer software. Samples can be obtained from patient whole blood, cerebrospinal fluid, or other biological fluids and tested with a minute quantity of disease associated antigen. Culture of the T-cell sample followed by ELISPOT analysis allows scientists to determine the number of T-cells that are activated by the antigen with extraordinary sensitivity: one cell in a sample of 200,000 cells can be detected.

Behring Dade Diagnostics is developing an assay for the detection of human papillomavirus mRNA in cervical smears

Matritech, Inc., Newton, Mass has completed preclinical evaluation of NMP179 demonstrate its ability to detect pre-cancerous cervical abnormalities. NMP179 is one of a series of diagnostic products based on Matritech's proprietary technology, which correlates the level of nuclear matrix proteins (NMPs) in body fluids to the presence of cancer. The American Cancer Society estimates that 13,700 new cases of cervical cancer will be diagnosed in the United States during 1998.

Digene Corp., has launched the Hybrid Capture II HBV DNA Test for research and investigational use in the U.S. Preliminary studies indicate that Digene's HC II HBV test can detect as few as 6,000 viral genome copies/ml of the hepatitis B virus and measure viral load in patients up to 1 billion copies/ml.

Epitope, Inc., Beaverton, Ore, has received FDA clearance for the STC Cotinine Micro-Plate EIA for use in the qualitative determination of cotinine in oral fluid collected with the OraSure Oral Specimen Collection Device manufactured by Epitope, Inc.

Lifestream Technologies is developing the Cholestron PRO II, a rapid, hand-held, cholesterol diagnostic device. The Cholestron Instrument is currently in the process of FDA clearance. The Cholestron incorporates the Privalink smart card technology and operating system that allows physicians, pharmacists and individuals to communicate in real time and offers customized, personal, wellness programs within minutes of testing.

Bayer Diagnostics has launched the CLINITEK Microalbumin Test strip which is read by the CLINITEK 50 Point of Care Analyzer. Results are printed in one minute for albumin, for creatinine - another substance found in the urine - and for the ratio of albumin-to-creatinine, which is important for an accurate reading of albumin levels.

bioMérieux Vitek, has launched the VITEK 2, the next generation of technology for microbial identification and analysis of antibiotic susceptibility. The VITEK 2 is designed to identify gram positive cocci and gram negative bacilli and assess their resistance to a total of 78 antibiotics. It can also identify yeast and yeast-like organisms. In addition, VITEK 2 is capable of testing 12 antibiotics for effectiveness against Streptococcus pneumonia, a significant public health threat because of increasing frequency of penicillin resistance.

Meridian Diagnostics, has received FDA clearance to market the Premier Platinum HpSA, a direct antigen test that can identify active H. pylori from stool samples. It is totally non-invasive, requires no special handling or preservation methods for specimens, and offers sensitivity and specificity of greater than 95%.

Toa Medical Electronics Co. has announced it will change its name to Sysmex Corp., effective Oct. 1, 1998. Toa will collaborate with Hoffmann-La Roche & Co. Under the terms of the agreement, both parties will collaborate in sales and marketing of each company's products in various territories of the world and will cooperate in joint research and development for future products. The financial terms of the agreement are not disclosed.

Metra Biosystems, Inc. has signed a cross-licensing agreement with Beckman Coulter, Inc. for a patent owned by Beckman Coulter. Beckman Coulter gains rights to develop, commercialize, and sell Metra's Pyrilinks-D (Dpd) test for use on its automated laboratory analyzer, the ACCESS immunoassay system. In addition, Metra gains rights under the Beckman Coulter patents to continue to make, use, and sell the Alkphase-B formation marker currently marketed by Metra on a worldwide basis.

Hewlett-Packard's Chemical Analysis Group will invest $20 million over the next year and $80 million in the four years after that, in order to further develop and commercialize Caliper Technologies Corp's LabChip system, which uses liquid integrated circuitry to create complete chemical processing systems on a microchip. Caliper has collaborations related to LabChip with Hoffman- LaRoche AG and The Dow Chemical Co. Hewlett-Packard already has a collaboration with Affymetrix Inc. for development of Affymetrix's GeneChip technology, which analyzes DNA sequences. Affymetrix has a collaboration with one of Caliper's partners, Roche.

Oncogene Science Diagnostics, Inc. and Fujirebio, Inc. have entered into a four-year collaborative agreement for the development, manufacture, and sale of cancer diagnostic products in the Japanese market. Under terms of the agreement, Fujirebio has obtained a non-exclusive license to develop, manufacture and sell several proprietary cancer assays. In exchange, Oncogene Science Diagnostics is to receive royalties on product sales, licensing fees and R&D funding. Diagnostic products will be formatted on Fujirebio's proprietary automated clinical instrument called Lumipulse.

Pacific Biometrics Inc. is developing the Osteopatch, a proprietary sweat patch system to measure an indicator of bone resorption.

healthcare technologies to produce kits for diagnosis of mycoplasma pneumonia

Savyon Diagnostics Ltd., a wholly-owned subsidiary of Healthcare Technologies has launched Sero Mp, a new line of products for the serological diagnosis of Mycoplasma pneumonia infection in a one hour ELISA assay. The Savyon Sero Mp kits provide differential determination of IgG, IgA and IgM antibodies to Mycoplasma pneumonia, allowing identification of the phase of the disease.

Simplex Medical Systems has received FDA approval for its saliva collector. Simplex has developed a line of rapid non- invasive saliva tests for HIV 1 and 2, hepatitis B, ulcers, mumps, measles, rubella, PSA and other diseases, some of which have received approval to be marketed internationally, including Hong Kong, Venezuela, Spain, Costa Rica, Italy, Bahamas, New Zealand, Dominican Republic, Peru, Kuwait and Argentina.

NeoPath's AutoPap System has received US FDA approval for use as a primary Pap smear screener. The AutoPap Primary Screening System is the world's first device to receive FDA approval for use in automated initial Pap smear screening for the early detection of cervical cancer. In support of this premarket approval NeoPath provided performance data from a large-scale, prospective, intended use clinical study comprised of more than 25,000 patient slides from five clinical laboratories showing that overall the AutoPap achieves greater accuracy in early diagnosis of cervical disease and reduces both false negative and false positive test results.

Quidel Corp. has launched two new rapid tests for use in the clinical laboratory market that detect hCG -- 1) QuickVue SemiQ hCG Combo and 2) CARDS QS hCG - Serum/Urine Test

Chromatics Color Sciences International, Inc. has introduced the Colormate TLc-BiliTest, a pain-free NIR alternative to the current heel stick blood tests performed to monitor bilirubin levels in newborns. The device operates as a battery-powered, hand-held instrument, or as a portable briefcase unit using an external power source, with a battery backup.

Biex Inc. has received FDA approval to market its SalEst, a saliva test for women between their 22nd and 36th weeks of pregnancy, which detects estriol, which can surge several weeks before preterm labor. SalEst will be available within six weeks for under $100. SalEst was 98 percent reliable in identifying women not at risk for preterm labor, despite any other risk factors.

Compucyte Corp. has received an exclusive license from Stanford University for a rapid assay of bacterial sepsis in newborns. CompuCyte is developing a commercial version of the test based on a simple, self-contained test cartridge and a point-of-care cellular analyzer that a physician, nurse, or technician can operate to obtain results within minutes. The test measures CD11b, a protein that appears on the surface of neutrophils within five minutes of their exposure to bacteria.

Strategic Diagnostics Inc. has received 510(k) market clearance from the FDA to market its Macra Lp(a) Enzyme Immunoassay Kit for the quantitative measurement of lipoprotein(a) in serum or plasma.

Laboratory Corporation of America (LabCorp) has formed an exclusive partnership with VIRCO, Belgium to offer a new tests called the Antivirogram which measures the susceptibility of HIV to all approved anti-retroviral drugs and therefore will help guide the use of multi-drug cocktails for the treatment of HIV/AIDS.

Diametrics Medical, Inc. has received FDA approval to market the new Glucose Module for the IRMA SL Series 2000 Blood Analysis System. The Glucose Module integrates technology developed by Johnson and Johnson's LifeScan unit for its SureStep Pro Professional Blood Glucose Management System. With this module, the same SureStep Pro glucose test strips can now be used with both the IRMA SL System and the LifeScan System. The companies will collaborate on worldwide sales and marketing efforts, which will begin immediately.

Technical Chemicals & Products, Inc. has introduced its NIDA specific One Step Drug Scan complete panel of diagnostics for drugs of abuse screening. As many as eight different drugs of abuse can be tested using the One Step Drug Scan with results provided in approximately five minutes. Each of the drug screens in TCPI's One Step Drug Scan are Class II devices and have received 510(k) clearance by the U.S. Food and Drug Administration.

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