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 April 2003
Abbott Laboratories has entered into a co-marketing agreement with Medical Analysis Systems, Inc. (MAS), a Fisher Scientific International Inc. company, for the VecTest family of antigen-based assays, including a rapid test for detecting the West Nile virus in infected mosquitoes. The proprietary VecTest products, developed and manufactured by MAS, also include rapid tests for detecting malaria and Saint Louis encephalitis in infected mosquitoes. MAS also will provide a rapid test for detecting the West Nile virus in infected birds following regulatory approval. Under the agreement, MAS will manufacture the tests and Abbott will have rights to market the product worldwide.
Bayer Diagnostics has received FDA clearance to market its VERSANT HCV RNA 3.0 Assay (bDNA), a predictive test that directly measures hepatitis C virus RNA levels in serum or plasma. The VERSANT HCV viral load assay is the first FDA-approved quantitative test to measure HCV viral load levels. Bayer has also introduced four fully automated hepatitis B assays: Anti-HBs, HBc Total, HBcIgM, and HBsAg designed for the ADVIA Centaur immunoassay system. These assays are only available outside the United States.
Beckman Coulter, Inc. has launched its FDA cleared Access OV Monitor, a new test that aids in the management of ovarian cancer. The test is designed for the quantitative determination of cancer antigen 125 (CA 125) levels in human serum and plasma.
Bio-Rad Laboratories, Inc. has received FDA clearance to market its Genetic Systems HBsAg EIA 3.0 and HBsAg Confirmatory Assay 3.0. These tests replace the company's existing Hepatitis B kits.
Dade Behring has received FDA clearance to market its D-dimer test on the Stratus CS instrument, for use in STAT and central laboratories and in acute care settings, such as emergency departments.
EXACT Sciences Corporation has signed an exclusive licensing agreement relating to the digital-PCR technology developed by Dr. Bert Vogelstein's laboratory at the Johns Hopkins Kimmel Cancer Center. The technology will be used for the development of future colorectal cancer screening and detection technologies that may enhance EXACT Sciences' PreGen-Plus assay. Digital-PCR is the underlying technology for digital protein truncation (dig-PT).
Focus Technologies has begun supplying public health labs, commercial laboratories and large hospitals with laboratory reagents for detecting Flavivirus (West Nile Virus) antibodies. Focus' products are based on protein antigen technology licensed from the CDC. To date, laboratories located in over 30 states have ordered Flavivirus (West Nile Virus) reagents from Focus.
Hycor Biomedical Inc. has received FDA clearance to market its Anti-Beta-2-Glycoprotein (beta-2-GPI) IgA autoimmune test. The test complements the beta-2-GPI IgG and IgM tests previously cleared in January 2003.
Integrated Nano-Technologies is developing BioDetect, a new DNA based testing system that will test for the presence of biological pathogens, such as the virus that causes severe acute respiratory syndrome (SARS) as well as anthrax, and smallpox. The BioDetect system will return results in less than 30 minutes, and is small enough to be carried for use outdoors or installed in air circulation systems.
Matritech Inc. has received FDA clearance to market its NMP22 BladderChek test as a rapid screening test that physicians can use in their offices to help diagnose patients with bladder cancer. In July 2002, Matritech received FDA clearance to market the NMP22 BladderChek test for monitoring patients previously diagnosed with bladder cancer. Cytogen Corporation distributes the test to urologists in the United States.
MedMira Inc. has received FDA clearance to market its three-minute Reveal Rapid HIV-1 Antibody test. Cardinal Health is the exclusive distributor for the U.S. market.
Pelikan Technologies, Inc. has received FDA clearance to market the Pelikan Sun, a fully automated, self-contained lancing system for glucose self testing.
Roche Diagnostics has received FDA clearance to market the Cobas Amplicor HIV-1 Monitor Test (version 1.5) an enhanced version of Roche's PCR assay used to measure the amount of HIV-1 RNA (viral load). The test has the enhanced ability to quantify HIV-1 Group M subtypes A-G. Roche also announced that it has begun installation of its PCR-based West Nile virus blood screening systems at leading North American blood centers, in preparation for clinical trials scheduled to begin on or before July 1.
ScheBo Biotech USA is developing a colorectal cancer screening test based on a patented procedure for determining Tumor M2-PK in stool samples. Tumor M2-PK is an enzyme for the regulation of tumor metabolism in the human body. The test will become available as a laboratory test in mid April 2003.
Sontra Medical Corporation has completed an initial clinical study in patients with diabetes with its Symphony Diabetes Management System, a non-invasive continuous glucose monitor. The Symphony glucose biosensor measures the continuous flow of glucose through the skin, which is made permeable with Sontra's SonoPrep skin permeation device.
Sysmex Corporation and Toshiba Corporation are collaborating in the development of technology for micro-invasive self-measurement of blood sugar levels. The technology combines Sysmex's micro-invasive tissue fluid extraction technology with Toshiba's optical sensing technology and allows glucose levels to be measured using interstitial fluids instead of the blood. The companies are aiming for commercialization in 2005.
Product developments - March 2003
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Last modified: May 1, 2003