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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 November 2001
Amplistar, Inc. is developing immunoassays for the early detection of colon, lung and prostate cancers. Apogent Technologies Inc. has acquired Forefront Diagnostics, Inc. Forefront manufactures rapid diagnostic test kits for the detection of drugs of abuse. Apogent's Applied Biotech division will consolidate the Forefront production in its rapid test diagnostic manufacturing facility in San Diego. Forefront's revenues are expected to be approximately $14 million in the next 12 months. Applied Imaging Corp. has received a European patent for the isolation and enrichment of rare cells from blood samples. The technology is used to isolate rare cells, such as circulating tumor cells or fetal cells, from blood samples and to provide enriched samples for further analyses. ARUP Laboratories, Inc and Scantibodies Clinical Laboratory, Inc are collaborating to offer Scantibodies' CAP, CIP and CAP/CIP ratio parathyroid disease tests. Avitar, Inc. and Quest Diagnostics Incorporated have signed an agreement whereby Quest will distribute Avitar's ORALscreen tests to detect drugs of abuse. bioMerieux, Inc. has received FDA PMA market celarance for its NucliSens HIV-1 QT quantitative viral load assay, using the Nucleic Acid Sequence-Based Amplification (NASBA) technology. The test can be used to monitor the effects of anti-retroviral therapy by measuring changes in HIV-1 RNA levels. Calypte Biomedical Corp. and SA Scientific Inc. are collaborating to develop a new urine-based rapid HIV-1/2 antibody test that can provide results in as little as 15 minutes. Cholestech Corporation and Bayer Corporation, Diagnostics Division have begun a co-marketing program for POL management of cardiovascular disease and diabetes. Under the Risk Management Program the companies will co-market Cholestech's L-D-X System for lipid management and Bayer's DCA 2000+ Analyzer for glucose testing. Chronix Biomedical is developing a serum-based test to detect bovine spongiform encephalopathy (BSE) - Mad Cow Disease. Clairus Technologies, Inc. has signed an exclusive license agreement with the University of Pennsylvania with for worldwide rights to a technology that will enable diagnostic testing of steroid responsiveness in patients with Crohn's disease. The test is an RT-PCR molecular diagnostic that monitors the transcriptional activity of two genes that are within a gene family whose expression is strongly influenced by pro-inflammatory mediators. diaDexus, Inc. has licensed its proprietary Cathepsin K genomics-based diagnostic blood test to Quest Diagnostics for the detection and monitoring of osteoporosis. Cathepsin K is a protein implicated in the resorption of bone matrix. DiaSys Corporation had launched Parasep, a disposable product line for collecting and processing patient specimens for intestinal parasite analysis. The Parasep product line was acquired in the September 2000 acquisition of Intersep, Ltd. Diagnostic Systems Laboratories Inc. (DSL) has acquired Oxford Bio-Innovation Ltd. (OBI), a joint venture between Oxford Brookes University and Serotec Ltd. OBI markets products for the measurement of Inhibin and Activin levels used for male infertility, assessment of ovarian reserve, prediction of IVF outcomes, and differential diagnosis of ovarian cancer. Egea Biosciences has been awarded a Defense Advanced Research Projects Agency (DARPA) grant to develop a DNA biochip sensor for the detection of biowar agents. Guava Technologies Inc., a developer of cellular analysis systems, has launched the Guava Personal Cytometer (Guava PC), a benchtop cellular analysis system. The compact, portable system is capable of providing a wide range of cellular assays on a single instrument. The integrated system, composed of the Guava PC instrument and laptop computer, software and reagents can perform cell counting and viability, protein expression and apoptosis. Hamilton Thorne Biosciences is developing its DNA-based Ramification Amplification (RAM) for Chlamydia detection in clinical samples collected in Cytyc PreservCyt fluid. Healthy Home Air has introduced Allergen Alert that allows people to detect and identify the levels of the eight most common indoor allergens, including four types of molds, which could be affecting the air quality in their homes. Each Allergen Alert kit contains two allergen collection traps, a video explaining the dangers of household molds and allergens and how the kit works, a brochure and instruction booklet, and a postage-paid return box for sending the dust samples collected to the laboratory for testing. The allergen traps attach to a standard vacuum cleaner hose to collect a sample of dust. The sample is sent to the laboratory for testing, and within two to three weeks the user receives a report. IGEN International, Inc. has acquired exclusive rights from the University of California to a proprietary biomolecular marker, known as FPB for the diagnosis and medical care of patients with venous thromboembolic (VTE) disease, which includes deep vein thrombosis (DVT) and pulmonary embolism. International Technidyne Corp. and Instrumentation Laboratories, SPA have entered into an agreement whereby IL will become ITC's exclusive distributor in Italy, Spain, Portugal, Belgium, Netherlands, Luxemburg and the UK. IL will market PROTIME 3 to physician office laboratories, anticoagulation therapy clinics and hospitals. Lumitest Ltd. has developed the TCL Photometer that measures the oxidation ability (or free radicals activity) of body fluids and tissue suspensions. The instrument uses non-invasive Thermo-chemi-luminescence (TCL). Matritech Inc. has introduced its point-of-care test, NMP22 BladderChek for bladder cancer. Similar to a pregnancy test, NMP22 BladderChek test would be used in conjunction with cystoscopy. MicroSense International, LLC is developing its Pushita minimally invasive interstitial fluid technology to measure cholesterol over the range of 25mg/dl to 300mg/dl. Nymox's Neural Thread Protein (NTP) urine Alzheimer's test is now available directly to consumers at HealthScreen America. The test costs $350 and requires a first morning urine sample and laboratory analysis. HealthScreen America will inform clients of his or her results within 7 to 10 days. Oncotech is developing the Radiation Resistance Assay as a tool to predict radiation resistance and chemotherapy resistance in patients with locally advanced Stage IIB-IVA primary cervical carcinoma. Physicians Laboratories, a division of Physicians Pharmaceuticals, Inc., has launched the FDA approved Menopause Home Test that measures FSH (Follicle Stimulating Hormone). SYN-X Pharma Inc has introduced its Nexus Dx point-of-care test for Alzheimer's disease. The test measures glutamine synthetase in whole blood. Thermo Electron Corporation and Meridian Bioscience, Inc. have signed agreements to jointly distribute point-of-care test kits produced by each company. Meridian will market in the U.S. Thermo Electron's FLU OIA and the C. difficile test for toxin A (CdTox A OIA). Thermo Electron will market in the U.S Meridian's Rotavirus test (ImmunoCard STAT! Rotavirus) and E. coli kit (ImmunoCard STAT! E. coli 0157 Plus). Trinity Biotech plc has entered into an agreement to acquire the Biopool Hemostasis Division from Xtrana Inc. The purchase consideration will be $6.25m comprising an up-front cash payment of $3.6m and the balance payable in deferred payments over a 36 month period. ViroLogic, Inc. has launched PhenoSense GT that combines ViroLogic's two proprietary assays: PhenoSense HIV, its rapid, direct and sensitive phenotypic resistance test, and GeneSeq HIV, its genotypic assay.
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