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 October 2001
Abbott Laboratories has announced the intention to acquire Vysis, Inc. for $30.50 per share. The acquisition is structured as a cash tender offer for all of the shares of Vysis, to be followed by a merger in which remaining Vysis shareholders will receive the same cash price per share. The transaction value is approximately $355 million. The tender offer is expected to be completed before year end, subject to regulatory approvals and customary closing conditions. Vysis markets products for the evaluation and management of cancer, prenatal disorders and other genetic diseases. In September 2001, Vysis obtained exclusive license to Roche intellectual property and technology for DNA probe technology uniquely identifies fetal cells in mother's circulation.
Abbott Laboratories has completed the previously announced purchase of an additional $1 million in SpectRx common stock, associated with a milestone under a program to commercialize SpectRx's continuous glucose monitoring technology. Abbott and SpectRx are jointly developing the technology. Under a 1999 agreement, Abbott has exclusive worldwide marketing rights to SpectRx's interstitial fluid continuous glucose monitoring technology.
Altec is developing a light-weight wearable sensor that will detect the presence of organophosphate compounds that have accumulated in the body. OP compounds are the active ingredients of over 25,000 household and agricultural pesticides and insecticides. Also they are the main component of most commonly used fertilizers, and of nerve agents, such as Sarin, that are used by terrorists and in chemical warfare.
AlleCure Corp. has entered into a research collaboration with BD Biosciences to develop assays in support of AlleCure's AlleVax treatments for allergies and various autoimmune diseases. The collaboration will focus on the development of laboratory tests that may be used for allergy diagnosis, confirmation of vaccine efficacy, and continued patient monitoring before, during and after immunotherapy.
Ambry Genetics Corp. has developed a tool to test for more than 900 mutations of the cystic fibrosis (CF) gene. The Ambry Test: CF is also capable of discovering previously unknown mutations that could lead to the disease. The test costs $285 and is already in use by physicians, genetic counselors and sperm banks to provide early warnings to prospective parents.
Applied Spectral Imaging has received FDA clearance to market its BandView karyotyping system for in vitro diagnostic use as an aid to cytogeneticists in diagnosing birth defects, genetic diseases, cancer and the effect of cancer treatments. ASI has developed the SKY technique, which uncovers hidden abnormalities in chromosomes.
Beckman Coulter, Inc. has begun shipping the COULTER LH 700 series analyzers, a new line of hematology systems that perform routine and emergency blood cell counts and analyses on platelets, white blood cells and red blood cells, including nucleated red blood cells that can indicate early stages of disease. The LH 700 series systems incorporate Beckman Coulter's new AccuCount technology that extends the upper limit of white blood count linearity from 140,000 cells/mL allowed by previous technology to 400,000 cells/mL, and platelet linearity from 1.5 million cells/mL to 3 million cells/mL.
BICO, Incorporated (Biocontrol Technology) subsidiary Rapid HIV Detection Corp. has introduced its InstantScreen Rapid HIV test. BICO recently acquired the exclusive worldwide marketing rights to InstantScreen, which was developed and is manufactured by the German American Institute for Applied Research (GAIFAR) in Potsdam, Germany. InstantScreen delivers results in 5-30 seconds, requires no special training, no extra equipment or refrigeration, and uses only a small amount of finger prick blood. A positive result of the InstantScreen can be verified within minutes with InstantConfirm.
A group of healthcare executives, backed by two leading private equity firms, announced today that it has completed the $408-million acquisition of the Healthcare Business and corporate stock of Carter-Wallace, Inc. Carter-Wallace, Inc. has changed its name to MedPointe Inc. Dr. Anthony H. Wild is the Chairman and CEO of the new company.
Cel-Sci Corporation has signed a joint development agreement with Biomedex, to develop and manufacture rapid anthrax human screening and rapid anthrax human diagnostic tests.
Cerus Corp. and Baxter Healthcare Corp. are collaborating on the development of the INTERCEPT Blood Systems, which utilize Helinx technology, to enhance the safety of blood transfusions. The companies are seeking U.S. and European approval of the INTERCEPT Platelet System and are conducting a Phase III clinical trial of the INTERCEPT Plasma System. In addition, the companies are preparing to begin a Phase III clinical trial of the INTERCEPT Red Blood Cell System.
Cytyc Corporation has acquired Pro-Duct Health, Inc., a privately-held company that has developed an FDA-approved ductal lavage device designed to enhance the evaluation of risk for breast cancer. The procedure is currently used for women who are at high risk for breast cancer and is expected to enable the detection of atypical changes in cells lining the milk ducts.
Digene Corporation has received FDA clearance to market a high-volume sample throughput instrument application for Hybrid Capture 2 Chlamydia/Gonorrhea testing using its Rapid Capture System for the simultaneous detection of Chlamydia trachomatis (CT) DNA and Neisseria gonorrhea (GC) DNA in cervical specimens.
Disease Sciences, Inc. and BioTec Global Limited are developing a urine test for Bovine Spongiform Encephalopathy (mad cow) in cattle. Creutzfeldt-Jakob Disease in humans and other TSE's (Transmissible Spongiform Encephalopathies).
Efoora, Inc. announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food & Drug Administration has granted an Investigational Device Exemption (IDE) for Efoora's HIV Rapid Test. The assay is based on proprietary technology of Virotek, an in-vitro diagnostic and device manufacturer that is a subsidiary of Efoora.
Embryotech Laboratories, Inc. has received FDA clearance to market its FertilMARQ Home Diagnostic Screening Test for Male Infertility that provides an assessment of sperm concentration, based on the World Health Organization guidelines. The kit contains all the necessary components to evaluate two separate semen samples in the privacy of one's home. The procedure is simple and results are obtained within minutes. By comparing the color result in the test well to a standard reference color, a man can determine if his sperm concentration meets the minimum fertility requirement of 20 million sperm per milliliter of ejaculate established by W.H.O. FertilMARQ will be marketed as BabyStart, a joint "his-and-hers" fertility test that combines ovulation (mid-stream, LH surge) tests with the FertilMARQ test. The FertilMARQ test kit is expected to be in available in drug stores by the end of November. Both his-and-hers test kits are currently available in Europe and Asia through Embryotech's partner, Med-Direct International.
Genaco Biomedical Products, Inc. has entered into a multi-year agreement with Luminex Corporation permitting Genaco to develop and commercialize reagent kits based on the Luminex LabMAP platform for the Chinese in-vitro diagnostics market. The system will be marketed in China under the Gena MASA brand name (Multi-Analyte Suspension Array). Initially, Genaco plans to release reagent kits for HIV, HCV, and Syphilis. Genaco plans to begin offering kits by the end of 2001.
Hema Metrics announced has introduced its Crit-Scan device, a non-invasive spot-check methodology to measure real-time transcutaneous hematocrit and saturated oxygen. The Crit-Scan consists of a small base unit with semi-durable handheld sensor cartridge. Optical, pneumatic, and control instrumentation are housed in the handheld component, while power management, data processing, and display functionality are resident in the base unit. Measurements are made by inserting a fingertip into the hand-held cylindrical sensor cartridge, immediately after which the optical cuff non-invasively assesses the hemodynamics of the finger by integrating specific pneumatic and photo-optical data.
ImmuneTech, Inc. and Luminex Corporation have entered into a partnership permitting in which ImmuneTech will commercialize a line of allergy tests based on Luminex's proprietary LabMAP technology. MyAllergyTest is designed to offer quantitative diagnostic data on a multitude of allergens while using only one drop of whole blood obtained by fingerstick. ImmuneTech plans to launch MyAllergyTest during the Fall 2002 allergy season.
LINCO Research, Inc. has introduced the LINCOplex human cytokine kit for simultaneous multi analyte detection and measurement of 8 cytokines in a single 25 µl sample. This kit is the first in the LINCOplex line of immunoassay products, designed with Luminex technology and to be used with Luminex instrumentation.
Matritech, Inc. is developing the NMP22 BladderChek test, a point-of-care test for detection of bladder cancer in the doctor's office. In 2000, the FDA approved a NMP22 laboratory-based test for use as an aid in identifying bladder cancer in previously undiagnosed. The company is also working on a MALDI mass spectrometer method for a prostate cancer marker identified by Matritech's scientists. The company believes that with further clinical development mass spectrometry can form the basis for routine testing.
Meridian Bioscience, Inc., subsidiary Meridian Bioscience Europe Srl., has signed a distribution agreement with ScheBo Biotech AG to market ScheBo Pancreatic Elastase-1 Stool Test, a non-invasive, test for the detection and quantification of human pancreatic elastase-1.
MicroDiagnosis is developing the Pathogen Detection System, StatDetect. The device is a patented Liquid Crystal that can be used for the real-time detection of bacteria and viruses in blood, saliva, and urine. MDi believes that this technology could also be used as part of a surveillance system for the monitoring and detection of biowarfare agents in the environment before any traditional laboratory diagnosis or patient symptoms occur.
Molecular Staging Inc. has received a Small Business Innovative Research (SBIR) grant to develop a method of detecting Human Papillomavirus (HPV) transformed cells using Rolling Circle Amplification Technology (RCAT). RCAT can be used to analyze individual cells within a cervical sample and distinguish between transient benign infections and cells that are progressing to cancer. The goal is to help clarify ambiguous cytology results and better identify women who are at risk of developing cervical cancer.
Trinity Biotech plc has launched its Uni-Gold Malaria one-step test for the detection of Plasmodium falciparum, one of the parasites that cause malaria.
Commonwealth Biotechnologies, Inc. and Vigen, Inc., have filed for patent protection of CBI's proprietary diagnostic platform for quantitation of DNA attributable to any one of the 8 human herpes viruses. CBI and Vigen formed a joint venture in April 2000 for the express purpose of commercializing high throughput rapid screening assays for the detection of Herpes and AIDS related viruses and test agents which affect virus replication.
Visible Genetics Inc. has acquired Virco's international research laboratory for $829,000. The Cambridge operation will become VGI's principal international research hub. Visible has received FDA clearance to market its gene-based test to tell whether an HIV patient's virus is mutating to make a particular drug therapy fail, important to know so the person can switch AIDS medications.
Product developments - September 2001
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Last modified: November 01, 2001