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.

ABAXIS has received FDA clearance to market three new analytes, creatine kinase (CK), potassium and CO2, for the Piccolo Blood Chemistry Analyzer for the medical market. Sodium, will be submitted to the FDA soon. The new analytes will be key components to the MetLyte 7 panel, scheduled for introduction in Europe October 1999. The MetLyte 7 panel is intended for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma or serum. Following the acceptance of sodium, the MetLyte 7 panel will be introduced to the U.S. market.

Atairgin Technologies in collaboration with MD Anderson Cancer Center, Houston, Texas have developed a blood test for ovarian cancer. The new test measures blood levels of bioactive lipid regulators, known as lysophospholipids, which have been shown to be exceedingly high in abnormal tissues. The presence of the tumor marker lysophosphatidic acid (LPA) has been demonstrated to be independent of the stage of tumor growth and may, therefore, provide an early means for detecting ovarian cancer.

Binax Inc. has received FDA clearance to market a new pneumonia test that detects an antigen, or protein, present on S. pneumoniae bacterial cells that gets into patients' urine soon after symptoms appear. Binax expects to ship the tests to doctors' offices immediately. The test will cost $15 to $20.

Biosite Diagnostics has entered into an antibody development and licensing collaboration agreement with Corixa Corporation. Biosite will use the Biosite Discovery Omniclonal technology to generate antibodies for Corixa's use in conducting protein target research for cancer, infectious and autoimmune diseases.

Calypte Biomedical has signed a definitive distribution agreement which will give Carter-Wallace, Inc. the exclusive U.S. sales and marketing rights for Calypte's HIV products in the hospital, public health and reference lab markets. Carter-Wallace will distribute Calypte's three FDA-approved products, which include: 1) the urine HIV-1 screening test, 2) the urine HIV-1 supplemental Western blot test, and 3) the serum HIV-1 supplemental Western blot test.

Chiron Corporation and Abbott Laboratories have signed an agreement under which Chiron has licensed to Abbott its hepatitis C (HCV) patent rights for use in nucleic acid diagnostics. The worldwide, semi-exclusive license, which excludes blood screening, allows Abbott to research, develop, make and sell HCV nucleic acid probe products for in vitro diagnostics. Chiron retains the right to grant limited additional licenses to others in this field.

Cholestech Corporation has received FDA clearance for the company's L.D.X alanine amino transferase (ALT) test. The company plans to file with the Centers for Disease Control (CDC) for waived status under CLIA by the end of September 1999. We anticipate launching ALT within Europe, and as a moderately complex product in the United States, by the end of this calendar year.

CLI Oncology has developed the METAtest Immunohistochemical Stain Kit. The kit uses a novel metastatic marker that can predict metastatic activity in a variety of human tumor types. was discovered and patented by the company.

The DiaSorin Breath Test Group has introduced the UBT Breath Test, a diagnostic kit that directly detects the presence of an H. pylori infection. It is the only breath test that has been approved by the FDA to both diagnose an active H. pylori infection as well as to monitor H. pylori infection post-treatment to ensure that the patient has been cured.

Hemagen Diagnostics has received FDA clearance to market the VIRGO(R) (beta)2 Glycoprotein I IgA Antibody Kit, the VIRGO (beta)2 Glycoprotein I IgG Antibody Kit, and the VIRGO (beta)2 Glycoprotein I IgM Antibody Kit. These ELISA kits aid in the diagnosis of Primary and Secondary Antiphospholipid Syndrome.

Kumetrix is developing a silicon micro-needle device blood glucose monitoring. The device consists of a disposable cartridge containing silicon micro-needles and a hand-held, battery-powered electronic monitor. The patient simply presses the monitor against the skin, causing a micro-needle to penetrate and draw a blood sample. Blood immediately flows through the needle into a tiny reservoir, where chemical reagents react with the glucose to produce a color. The entire one-step process can be completed in less than a minute.

Lexon, Inc. has agreed to merge with Cancer Diagnostics, Inc., a Utek Corp. subsidiary which owns the exclusive worldwide license to a patent pending blood test for lung cancer, the Telomerase Assay. The agreement is expected to close in early January 2000.

Lexon also owns the exclusive worldwide rights to a blood test for colon cancer, the Ebaf Assay. The development of the colon cancer screening test is currently being conducted at North Shore University Hospital in Manhasset, New York, under the direction of Dr. Siamak Tabibzadeh, the developer of the test.

Polymer Technology Systems, Inc. has introduced the POC BioScanner 2000 test system for the management of diabetes and diabetic complications. The BioScanner 2000 resembles a traditional glucose meter, but can also test for cholesterol, ketone, HDL, LDL, triglycerides, hemoglobin A1c, microalbumin and creatinine. The device is CLIA waived. More tests are currently in development for the BioScanner 2000 and will be released to both the professional and home consumer markets in the near future.

QIAGEN N.V. and Becton, Dickinson have agreed to form an equally-owned, worldwide joint venture. The Swiss-based joint venture, named PreAnalytiX GmbH, will develop, manufacture, and market integrated systems for the collection, stabilization, and purification of nucleic acids (DNA and RNA) for molecular diagnostic testing. It is expected that PreAnalytiX will launch its first product in late 2000.

Quidel Corporation has introduced the improved QuickVue One-Step H. pylori II Test for use in waived physician office laboratories.

Response Biomedical and the Prostate Centre at Vancouver Hospital have agreed to co-develop a one-step, rapid PSA test to detect prostate cancer using Response Biomedical's patented RAMP diagnostic system. Response Biomedical's patented RAMP system will deliver highly accurate results in less than 10 minutes.

Selfcare Inc. has received FDA clearance to market its Excel GE, a low cost alternative electrochemical blood glucose monitoring test strip for use with Glucometer Elite R meters. The strip is the first in a series of low cost alternative test strips designed to work seamlessly with the installed base of existing electrochemical glucose meters. The strips are being produced at the company's manufacturing facility in Inverness, Scotland with U.S. shipments expected to begin within several weeks.

Syva Company, a subsidiary of Dade Behring, Inc has agreed to purchase the assets of Point of Care Technologies, Inc. Point of Care manufactures the Genie Cup, a one-step drugs of abuse screening device that integrates sample collection, testing, transportation and storage in a single device.

Welch Allyn Inc. has invested in Cyrano Sciences Inc., a company that develops chemical sensors able to digitize smells. The goal of the collaboration is to produce products for primary- care physicians based on an electronic nose, using Cyrano's patented polymer composite sensor technology.

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