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The following is a review of diagnostic product developments worldwideDEAR READER: Ah, Where did the summer go? Hope ya'll had a wonderful, healthy summer and are ready as I am to roll up those sleeves and get back to work. The following are some events that took place from June to August. Welcome back to StratCom's monthly update.
Product developments in Summer 2001
Abbott Laboratories has increased its involvement with SpectRx Inc.'s continuous glucose monitoring program and will make a $2 million milestone payment in the form of an equity investment in SpectRx's stock before Aug. 31, 2001. Abbott has also entered into an agreement with Vysis, Inc. for the worldwide distribution of two genomic tests to assist in the management of breast and bladder cancer. Akzo Nobel transferred Organon Teknika's in vitro diagnostics business to bioMérieux in a cash transaction of EUR 311 million ($277.4 million). As per July 1, the diagnostics activities have been consolidated into bioMerieux. Avitar, Inc. has begun marketing trials with Pinkerton, Inc. to develop and launch ORALscreen OSR, an automated analyzer for the detection of drugs of abuse utilizing the ORALscreen system for large volume users. Bayer Corporation today announced it has acquired certain development, manufacturing and sales agency rights for immunodiagnostic products for the detection of Hepatitis C (HCV) and HIV antibodies from Ortho-Clinical Diagnostics and Chiron Corporation. Bayer is also developing a full array of Hepatitis B and Hepatitis A assays for the ADVIA Centaur Immunoassay System. Bayer has been granted a license under patent rights of Roche Diagnostics GmbH and Dade Behring, relating to the development, manufacture and marketing of immunoassays that detect exposure to HIV Group O infection. Bayer Diagnostics has launched the Rapidpoint 400 Critical Care Analyzer. The Rapidpoint 400 is Bayer's first blood gas and electrolyte analyzer to be designed and developed for near patient testing sites such as the ICU, CCU, OR and ER. Biomedical Diagnostics, LLC has introduced its Mammastatin Serum Assay used to identify a woman's risk of developing breast cancer with a simple blood test. The company also announced that it has signed a letter of agreement with ARUP Laboratories of Salt Lake City, UT, to market and service the new technology. Biopool International Inc.'s shareholders agreed to change the company's name to Xtrana Inc. The company said it will trade on the OTCBB under the symbol, "XTRN." Biosite Diagnostics Incorporated is further developing its cardiac test program that was initiated in 1999. American Biogenetic Sciences Inc. has licensed its Thrombus Precursor Protein diagnostic marker to Biosite. At the AACC meeting, Biosite announced that it has validated the diagnostic utility of six proteins as markers for stroke and that it intends to immediately initiate development of a quantitative stroke diagnostic that could be used to aid in the diagnosis of stroke in acute care settings. Beckman Coulter, Inc. has introduced the next generation routine chemistry systems, SYNCHRON CX PRO models: the CX9 PRO, CX5 PRO and CX4 PRO. These instruments can run routine chemistry, critical care, immunoassays, thyroid, drugs of abuse and therapeutic drug monitoring. eMation Inc. has entered into an enterprise software licensing agreement with Beckman Coulter for the eMation DRMT Device Relationship Management system. The system is intended to expand the remote diagnostic capabilities of Beckman Coulter's SYNCHRON LX chemistry analyzers to allow Web-enabled transmission of instrument data. Dade Behring introduced a new FDA approved hsCRP assay detects C-Reactive Protein levels in the range of 0.05-25 mg/dL. The assay can be used on the Dimension RxL, ARx, AR, XL and Xpand systems. The assay uses a Particle Enhanced Turbidimetric Immunoassay (PETIA) format. Also introduced was Dade's recently FDA approved Dimension Xpand Analyzer that offers some 70 routine chemistries and immunochemistries. Endocare Inc. will integrate Qualigen Inc.'s Total PSA, test with its diagnostic workstation for urology, under an original equipment manufacturer agreement. FlexSite Diagnostics, Inc. has introduced KidneyScreen At Home. The kit enables diabetes patients to collect a urine sample for microalbumin and mail it to FlexSite's laboratory in a dried state for testing. Hemagen Diagnostics has received FDA clearance to market Panels +, a new rotor for use on the Analyst, Clinical Chemistry Analyzer that incorporates four additional test methods: Carbon Dioxide, Phosphorous, Albumin and Direct Bilirubin together with ten previously cleared methods. The system is designed for use in the physicians office lab and the small clinic marketplace. INOVA Diagnostics has received FDA approval to market its QUANTA Plex ENA Profile 4 Immunoassay Kit Based on Luminex's LabMAP technology. This is the first clinical diagnostic application for the Luminex 100 system. Johnson & Johnson has acquired Inverness Medical Technology's diabetes care products businesses in a stock-for-stock exchange and LifeScan has entered into an alliance with Novo Nordisk A/S to develop and market a new family of diabetes management devices. OraSure Technologies, Inc. and Meridian Bioscience, Inc. have begun developing tests using OraSure's phosphor-based UPlink technology in the detection of infectious disease. The initial product UPlink Clostridium difficile Toxin A&B test, is designed to aid in the diagnosis of C. difficile associated disease. Polymer Technology Systems, Inc. has received clearance from the FDA to sell its HDL-cholesterol test strips directly to consumers. The test strip is part of the BioScanner 2000 personal blood chemistry system, designed for the management of diabetes and its complications. Quantum Magnetics, Inc., a subsidiary of InVision Technologies, Inc. is developing a POC device for iron-overload hereditary diseases such as hemochromatosis, thalassemia, and sickle cell anemia. The device is based on the company's magnetic sensor technology. Quest Diagnostics has launched QuestDirect, a service whereby individuals can access selected lab tests without first having to see their own physician. The tests include more than 25 health tests called QuesTests for cholesterol, osteoporosis risk, allergy, and full health profiles Prices for QuesTests vary from $20 for some single tests up to $150 for a comprehensive health profile. Roche Diagnostics introduced the E170 module for MODULAR ANALYTICS, a high volume throughput heterogeneous electrochemiluminescence immunochemistry analyzer, offering 50 different assays. Chiron Corporation and Roche Diagnostics have reached an agreement giving Roche the ability to manufacture and sell probe-based HIV-1 and HCV blood screening tests worldwide, in both single donor and pooled formats, for the life of the patents. Sigma has begun distribution of Ambion, Inc.'s patented RNA stabilization product RNAlater for the research market, on a non-exclusive basis. RNAlater stabilizes RNA in tissues and cells for subsequent RNA isolation and for ambient temperature shipping and storage of samples. The company also launched the First Medical Alpha Dx POINT-OF-NEED System for POC testing of cardiac markers CK-MB, myoglobin and troponin I. Unilever is looking for buyers for its women's health diagnostics subsidiary, Unipath Limited. Unipath is best known for its Clearblue home pregnancy test and ClearPlan range of home ovulation and fertility monitoring systems. The company also produces a range of clinical diagnostic products for the medical profession. Ventana Medical Systems has signed a non-exclusive co-marketing agreement with BD Biosciences Clontech Laboratories to jointly promote Clontech Atlas Microarrays together with the Ventana DISCOVERY system as a platform for performing microarray analyses. Vysis, Inc. has granted a non-exclusive license to bioMérieux, Inc. under its U.S. Patent No. 5,750,338 (the Collins patent) and related patents that relates to nucleic acid diagnostic methods utilizing target capture and in vitro amplification. It is currently licensed by Gen-Probe Incorporated.
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