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 May 2003
Dear Readers, It's hard to believe that another year has passed so quickly and it is already time for our yearly summer vacation. There will not be an update to the information section of the web site for the months of July and August. See you in September. Have a great summer, with best regards, Shara Rosen.
Aerocrine Inc. has received FDA clearance to market the NIOX non-invasive test system to measure the concentration of nitric oxide (NO) in exhaled human breath - a responsive marker of airway inflammation in patients with asthma.
Beckman Coulter, Inc., has introduced the Total IgE test to determine general allergic reactions. The test is designed for the Beckman Coulter IMMAGE immunochemistry system and provides a quantitative determination of Immunoglobulin E (IgE) in serum and plasma.
Bio-Rad Laboratories, Inc. has received FDA clearance to market its Platelia Aspergillus EIA test kit for invasive aspergillosis. The test uses the EBA-2 monoclonal antibody in a microplate assay that utilizes blood samples for testing.
BIOSAFE Laboratories, Inc. plans to license its consumer collected Cholesterol Panel to clinical laboratories. The micro sample blood test is FDA approved for patient self-collection and includes all four lipid fractions: total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.
Calypte Biomedical has received FDA authorization for the use of its Cambridge Biotech HIV-1 Western Blot serum/plasma test as an additional specific test to be used with serum or plasma specimens obtained from subjects found to be reactive using rapid HIV-1 tests.
Chronix Biomedical is developing the Chronix BSE blood test to test for Mad Cow Disease on living animals. The test was developed through a German-American collaboration between the laboratories of Prof. Bertram Brenig, Director of the Institute of Veterinary Medicine, Georg-August University and Chronix Biomedical and detects blood RNA, not prion proteins.
Diagnostic Products Corporation has received a license from MBL of Japan to develop and commercialize diagnostic antinuclear antibody (ANA) assays on its IMMULITE immunochemistry analyzers, and applications for the DPC ANA lineBlot assay.
Genaissance Pharmaceuticals, Inc. has granted Prometheus Laboratories Inc. a license to a thiopurine S-methyltransferase (TPMT) diagnostic test that provides a genetic assessment of a patient's ability to metabolize the thiopurine class of drugs.
Hycor Biomedical Inc. has received FDA clearance to market its Anti-Cardiolipin (ACA) IgA autoimmune test. The test complements the ACA IgG and IgM tests previously cleared. ACA is used in the diagnosis of antiphospholipid syndrome (APS), which can occur as a complication of various autoimmune diseases.
Inverness Medical Innovations has received FDA clearance to market its Clearblue Easy Digital pregnancy test, the first test to display results in words. The digital display spells out "Pregnant" or "Not Pregnant", eliminating the need to interpret result lines.
Thermo Electron Corporation has introduced the GC OIA rapid test for the detection of Neisseria gonorrhea (GC) from an endocervical swab for females and from urine for males. The GC OIA test detects the proprietary L7/L12 ribosomal protein marker found within the cell. The test also uses the patented UFD (Urine Filtration Device), to concentrate and extract the antigen from male urine prior to placement on the OIA platform.
Product developments - April 2003
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Last modified: June 2, 2003