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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 November 1996

ABAXIS, Sunnyvale, CA has launched the Liver Panel Plus 9, designed to measure hepatic function with its Piccolo Point-of-Care Blood Analyzer. Other panels available for the Piccolo include: the General Health Panel 11, General Health Panel 8, Liver Panel Plus 9, General Chemistry 6, General Chemistry 7, General Chemistry 9 and General Chemistry 12.

The Microbiology division of AccuMed International, Chicago, has developed the Fungal Susceptibility Test, Sensititre YeastOne to measure the susceptibility of fungal agents to different types and concentrations of antibiotics. The test utilizes the company's proprietary non-toxic indicator reagent, alamarBlue technology, which provides a brilliant color code for susceptibility testing that turns red with positive results. With AccuMed's alamarBlue technology final results are available within 24 hours as opposed to more traditional technology which typically runs 48 to 72 hours.

Baxter Healthcare Corporation, Deerfield, ILL has announced that the company's hemoglobin therapeutic, HemAssist, has been cleared by the U.S. FDA to enter Phase III clinical testing in patients suffering from blood loss and shock caused by severe trauma. Baxter is the first and only company developing a hemoglobin therapeutic, or "blood substitute," to reach this advanced stage of trauma research.

Biocircuits Corp., Sunnyvale, CA, has received FDA approval to market its Thyroid Stimulating Hormone assay designed to run on its physicians' office IOS immunodiagnostic system.

OraVax, Inc. Cambridge, Mass has entered into a licensing agreement with bioMerieux Vitek granting bioMerieux exclusive, worldwide rights to develop human diagnostic products incorporating a proprietary OraVax antigen. The antigen, called CagA, is a component of H. pylori and is expected to be used in the development of diagnostic products for the detection of H. pylori infection.

Biopool International, Ventura, CA has signed a purchase agreement to acquire the assets of the Blood Group Serology (BGS) business from Organon Teknika. The BGS product line consists of more than 75 products used by blood-bank facilities located in hospitals, blood centers and commercial reference laboratories to screen for specific antibodies and to group and type whole blood.

Chiron Corporation and Biometric Imaging Inc., today announced a preferred partnership agreement to explore the use of Biometric Imaging's microvolume fluorimetry platform for cellular analysis. Microvolume fluorimetry is a laser-based imaging system which detects fluorescently-tagged cells held in stasis in a defined volume. Biometric Imaging's IMAGN 2000 platform and the 4T8 assay, have been cleared by the US FDA for CD4+ and CD8+ cell analysis.

Cytyc Corporation, Boxborough, Mass, announced that the U.S. FDA has approved Cytyc's claim that the ThinPrep Pap Test is significantly more effective than the fifty-year-old Pap smear method of screening women for cervical cancer. This is the first time the FDA has allowed a company to claim its product is significantly more effective than the conventional Pap smear. The FDA further confirmed that the quality of the cervical specimens prepared on Cytyc's ThinPrep System is significantly improved over that of the conventional Pap smear.

DiagnoCure Inc., Sainte-Foy Quebec has listed on the Montreal stock exchange. Founded in 1994, DiagnoCure Inc. is developing products for the diagnosis and treatment of genito-urinary cancers (bladder, prostate, kidney) and breast cancers.

Hemosol Inc., Toronto, has demonstrated that Hemolink, the company's first blood substitute product, substantially enhances the in vitro growth of red blood cells induced by erythropoietin. Hemolink is currently awaiting Canadian regulatory approval for Phase II clinical trials.

Intelligent Medical Imaging, Palm Beach Gardens, FL is adding 2 microscopic procedures to the Micro21 System. IMI and DiaSys Corporation have signed an OEM agreement that allows IMI to integrate the patented DiaSys wet-preparation specimen handling system together with the Micro21. In addition, IMI and Johns Hopkins Hospital will collaborate in the development of the bone marrow procedure for use on the Micro21.

Cornell University researchers have developed a method for detecting Escherichia coli organisms in food that takes about seven hours, as compared to the 48 hours required by current methods. The test involves glass capillary tubes containing a complex of heat-killed E. coli 0157:H7 and antibody conjugated with biotin, which is detected using avidin tagged with a fluorescent dye. Any E. coli in the sample being tested competes with the formation of this complex, reducing fluorescence.

Quidel Corp., San Diego, CA has signed an agreement to develop immunodiagnostic tests for use on Bayer Corp.'s CLINITEK urine chemistry analyzer.

Sienna Biotech Inc., Columbia, MD, announced today that it has received clearance from the US FDA to market its Copalis immunoassay system and the Copalis ToRC total antibody assay for the prenatal diagnosis of Toxoplasma, rubella and cytomegalovirus infections. The diagnostic tests make use of a new technology, Copalis, or Coupled Particle Light Scattering, which enables the performance of multiple diagnostic tests simultaneously, from a single sample in about 10 minutes. The completely automated system is based on the use of high resolution light scattering to measure microparticle aggregation. The technology uses flow particle analysis based on optical sizing, where the particles or aggregates flow singly through a finely focused optical beam produced by a semiconductor laser.

SYNSORB Biotech, Calgary, has acquired an exclusive license to develop and commercialize anew technology employs combinatorial chemistry to rapidly synthesize large numbers of soluble carbohydrate containing compounds.

NOAB Inc., Markham, ON has files a comprehensive patent application covering its core biosensor technologies that covers devices, assays and materials associated with its immunodiagnostic system. Their technology involves the use of phage display antibodies and solid state phospors to form a generic diagnostic biosensor.

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

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Last modified: December 03, 1996