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 Bio Medica Corp., Ancramdale, NY, has received Us FDA clearance to market an 8 panel Rapid Drug Screen which detects the presence or absence of THC, cocaine, opiates, PCP, amphetamines, benzodiazepines, methamphetamines, and barbiturates. The 8 panel Rapid Drug Screen utilizes the same proprietary, patent-pending on-site testing apparatus as the company's original 5 panel Rapid Drug Screen which the FDA cleared last year.

AVL Medical Instruments, Roswell, GA, has received FDA 510K clearance to market the OPTI Critical Care Analyzer which measures blood gases, electrolytes, measured total hemoglobin and measured oxygen saturation, on whole blood.

Biocircuits Corporation, Sunnyvale, Ca has developed a Free T4 assay designed to be used with the company's IOS immunodiagnostic system to allow testing in physicians' offices and other points of care. When FDA cleared, the Free T4 cartridge will complete a thyroid disease diagnosis panel and will bring the total number of cartridges available for use on the system to five. Biocircuits signed an agreement granting exclusive worldwide sales and marketing rights, as well as instrument manufacturing rights, to Becton Dickinson and Company.

Biologix International, San Francisco, has developed the EPOC system, a biosensor-based blood/gas analyzer for the point-of-care industry that produces test results in five seconds. Biologix expects to sell the device for $1,200.

Biosite Diagnostics, San Diego, Ca, has received US FDA permission to market the Triage C. difficile Panel, a rapid diagnostic for the simultaneous detection of the C. difficile common antigen and toxin A. Biosite plans to distribute the product via Fisher Healthcare.

Chromatics Color Sciences, International, New York, plans to launch a hand-held device and console for the non-invasive detection and monitoring of neonatal bilirubin infant Chromatics is currently finalizing discussions with potential partners for international medical distribution of the device.

Diagnostic Products Corporation, Los Angeles, has begun commercial shipments of the automated DPC IMMULITE 2000 which has received FDA marketing clearance for 31 tests for the new system.

Genentech, Inc. and DAKO A/S have signed an agreement under which DAKO will develop an in vitro diagnostic kit to be used to screen breast cancer patients for overexpression of the HER2 growth factor receptor. Under the terms of the agreement, Genentech will grant to DAKO a license for development of an immunohistochemical kit that will potentially be used to diagnose overexpression of HER2 in breast cancer patients.

Point of Care Technologies, Rockville, Md, is developing the Genie Cup, a fully integrated, single container collection, separation, transportation and testing device that detects drugs of abuse in urine. Test strips are located and sealed within the cup itself, making it virtually automatic to operate, with testing initiated by simply turning the lid. The first version of the cup tests for amphetamines, cocaine, methamphetamines, opiates, PCP and THC.

Hemispherx Biopharma, Philadelphia, Pa, has entered into a major research collaboration with R.E.D. Laboratories, Belgium dedicated to the development and commercialization of Chronic Fatigue Syndrome diagnostics. The test identifies a subset of CFS patients who are chronically ill and often bedridden. Hemispherx said it plans to implement the test immediately at clinical sites across the United States supported by Olsten Health Services under a new recently approved distribution agreement.

Immunomedics, Inc., Morris Plains, NJ, has received FDA market clearance for its ImmuSTRIP-HAMA IgG immunoassay for the detection and semi-quantitation of human antibodies against mouse protein. Significant serum levels of human anti-mouse antibody (HAMA) have been associated with patients receiving injections of mouse monoclonal antibodies for diagnostic and/or therapeutic purposes. Patients with high HAMA levels may be at risk for anaphylatic or other allergic-type reactions. Furthermore, patients developing HAMA can be at serious risk of having aberrant in-vitro laboratory results obtained with mouse monoclonal-based immunoassays.

Oncor, Inc., Gaithersburg, Md, has entered into a license agreement with the BD Microbiology Systems Division of Becton Dickinson and Company for Oncor's Sunrise Detection System. Under the terms of the agreement BD will utilize the Sunrise technology in future diagnostic tests in conjunction with its Strand Displacement Amplification (SDA) technology.

Ostex International, Seattle, Wa, has received from the FDA a significant modification of the Osteomark indication. Osteomark can now be used to identify the probability for a decrease in bone mineral density after one year in postmenopausal women not receiving hormonal antiresorptive therapy relative to women receiving HRT.

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