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The following is a review of diagnostic product developments worldwideThe 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.
Product developments in December 2002
Abbott Laboratories and Tecan have formed a long-term supply agreement for the development and commercialization of an automated sample preparation system for molecular diagnostic assays. The system is based on a magnetic separator system, proprietary to Abbott, which will be integrated onto Tecan's Genesis Freedom automated robotic and liquid handling workstation. The system is designed to streamline the nucleic acid sample preparation steps prior to performing Abbott's molecular diagnostic assays for hepatitis C and HIV assays. Affymetrix, Inc. and Arcturus Engineering, Inc. have entered into a strategic partnership that links microarray technology with laser capture microdissection. Arcturus will gain broad access to Affymetrix' GeneChip brand arrays, instrumentation and software. Affymetrix made a $3 million equity investment in Arcturus, as a part of Arcturus' recent $11 million private financing. Arcturus recently introduced the new AutoPix Automated Laser Capture Microdissection (LCM) System designed for microgenomic molecular analyses. Ani Biotech Oy and its Korean affiliate BioGemex Ltd. acquired Thermo Labsystems' diagnostics business that has now been transferred to the new company called AniLabsystems Ltd. Oy. The acquisition includes Thermo Electron's microplate format business. BD Biosciences has launched the BD FACSAria cell sorter that features high performance flow cytometer that includes cuvette-based cell sorting, self-contained fluidics and digital electronics that offers sample acquisition rates of up to 70,000 events per second. Beckman Coulter, Inc. has launched the SYNCHRON LXi 725 clinical system that provides 146 chemistry and immunoassay tests, including assays for basic critical care, metabolic, drugs-of-abuse, therapeutic drug monitoring, cardiac, thyroid, fertility and cancer, and other esoteric and specialty tests. Boston Biomedica, Inc. has released for sale and has begun to ship its first West Nile Virus product. Celera Diagnostics has received FDA clearance to market the ViroSeq HIV-1 Genotyping System, designed to detect mutations in the HIV-1 viral genome that confer drug resistance. The system will be manufactured by Celera Diagnostics and distributed by Abbott Diagnostics. Fresenius Medical Care Extracorporeal Alliance has named Radiometer America a preferred vendor of Radiometer's ABL77 point-of-care blood gas analyzer. This designation allows Fresenius Medical Care Extracorporeal Alliance clinicians to recommend and approve purchase of the ABL77 for use in cardiovascular operating rooms serviced by Fresenius Medical Care Extracorporeal Alliance. Metrika, Inc. has received FDA over-the-counter status for its Metrika A1c Now device that tests for glycated hemoglobin in the blood. Novitron International, Inc. has acquired all of the assets of Elan Diagnostics, Inc., a supplier of clinical chemistry instrumentation, reagents and support resources predominately to the Physician's Office Laboratory market in the US. Novitron will also acquire the assets of EDx's reagent assay manufacturing facility in Brea, California. Response Biomedical Corp. has formed an exclusive distribution agreement with Axis-Shield Diagnostics Ltd. to market the RAMP System and cardiac marker tests in the UK. Roche Diagnostics has received FDA clearance to market the COBAS AmpliScreen HCV Test, version 2.0 and the COBAS AmpliScreen HIV-1 Test, version 1.5. Roche has also received FDA clearance for the COBAS AmpliScreen Data Output Management System (DOMS), a computerized data collection system intended for use with the COBAS AmpliScreen System to collect specimen and test data. SpectRx, Inc. has received FDA Level 1 certified over-the-counter status for its SimpleChoice A1c test device for hemoglobin A1c (glycohemoglobin). Sulzer Carbomedics Inc. has entered into an agreement with Thoratec's International Technidyne Division (ITC) to co-market ITC's ProTime Microcoagulation System to cardiologists and cardiovascular surgeons. Thermo Biostar has introduced the CLIA waived PocketChem Urinalysis Analyzer and Aution 10 TA test strips that make up a fully portable urinalysis instrument in the US market. The test strips are supplied exclusively to Thermo BioStar by ARKRAY, Inc. Trinity Biotech plc has completed the acquisition of the specialty clinical chemistry product line from Sigma Diagnostics. The acquisition includes the specialty clinical chemistry business: ACE, Bile Acids, Lactate, Oxalate, G6PDH, the HDL, LDL and lipase product lines and an HbA1c product.
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