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 February 2003
20/20 GeneSystems, Inc. has introduced The BioCheck Powder Screening Kit to help first responders screen suspicious powders for bioterrorism agents such as anthrax and ricin toxin. The product requires no instruments and are being sold to fire departments and public safety personnel for under $25.
Aegera Therapeutics Inc. has now out-licensed rights manufacture and sell antibodies and kits targeted against Aegera's proprietary Inhibitors of Apoptosis (IAP) gene family to BD Biosciences Pharmingen, R&D Systems Inc, and MBL International. The antibodies are targeted against XIAP, HIAP1, HIAP2 and NAIP.
Bayer Diagnostics has introduced the ADVIA Centaur BNP (B-type natriuretic peptide) assay on its automated immunoassay platform -- the ADVIA Centaur Immunoassay System. The assay is currently available only outside the USA.
Ciphergen Biosystems, Inc. and Biosite Incorporated have entered into a collaboration for cardiovascular and other diseases to develop novel antibody and protein target components that can applied to either company's testing platform for diagnostic assays. Biosite will provide clinical samples and Ciphergen's Biomarker Discovery Center scientists plan to use its ProteinChip Biomarker Systems and related technology to discover differentially expressed protein biomarkers that may be useful as diagnostics.
Roche Diagnostics has granted Dade Behring a non-exclusive license to Roche's patented NT-proBNP (N-terminal prohormone brain natriuretic peptide).
BioStratum Incorporated and DakoCytomation A/S have signed an agreement according to which DakoCytomation is granted a license to develop and commercialize diagnostic applications of the monoclonal antibody, MetaStain that can be used to identify invasive epithelial cancers.
diaDexus, Inc. has acquired exclusive license rights from the Queensland Institute of Medical Research (QIMR), Queensland, Australia to cancer target, Testisin, a cell surface-associated serine protease.
Dynamic Health, LLC has introduced Ovulite, a lipstick-sized, portable and reusable, saliva-based fertility-testing product.
Hemagen Diagnostics, Inc. has signed an extension of its agreement to provide reagents and diagnostic kits to Roche Diagnostics Corporation for use on its COBAS Mira Clinical Chemistry Analyzer Platform for an additional four years. The agreement covers approximately thirty-five products manufactured by Hemagen's Raichem Division. August 6, 2002, Hemagen received FDA clearance to market a High Sensitivity CRP Reagent for use on clinical chemistry analyzers including the COBAS Mira Platform.
Hemoxymed, Inc.'s subsidiary, Molecular Geriatrics Corporation is developing a CSF-based test to differentiate Alzheimer's disease from patients with geriatric major depression. The test measures levels of an abnormally phosphorylated brain protein (tau protein).
Home Diagnostics has formed an international distribution partnership with MEDA of Solna, Sweden to market HDI's Prestige IQ blood glucose monitoring system and Prestige Smart System blood glucose test strips in Sweden, Norway, Denmark, Finland, Estonia, Latvia, and Lithuania.
Hycor Biomedical Inc. and Bayer Diagnostics have signed an exclusive, worldwide agreement for the development of autoimmune tests. Hycor will develop and manufacture a broad menu of tests for the ADVIA Centaur Immunoassay System, and Bayer Diagnostics' will retain exclusive rights to market the product. The tests will be developed using a combination of Bayer's chemiluminescence and Hycor's ELISA technologies.
Ischemia Technologies, Inc. has received FDA clearance to market the Albumin Cobalt Binding (ACB) test for detection of Ischemia Modified Albumin (IMA). IMA can be used as an aid to the early evaluation of acute coronary syndromes (ACS) prior to heart attack in patients presenting with chest pain suggestive of cardiac origin.
LabCorp has agreed to pay $4.5 million in cash to purchase certain assets in Northern California from Quest Diagnostics Incorporated following the completion of the acquisition of Unilab Corporation by Quest Diagnostics. The assets to be purchased by LabCorp include the assignment of four contracts with independent physician associations and the leases for 46 patient service centers, five of which also serve as rapid response laboratories, located throughout Northern California.
Medical Services International Inc. has been granted a worldwide license by the United States Public Health Service for use of its reagents in a Rapid Diagnostic Test Kit for the West Nile Virus. The company expects to have the test available by the end of March 2003, subject to regulatory approval. The reagents will be added to the company's line of VScan products.
OraSure Technologies, Inc. has received a CLIA waiver for the OraQuick Rapid HIV-1 Antibody Test.
American Red Cross Plasma Services and ProMetic Life Sciences Inc. will co-develop an improved protein purification process utilizing proprietary technologies from both companies to recover the most valuable therapeutic proteins from plasma in yields exceeding those currently obtained by standard manufacturing processes.
Quest Products, Inc. has introduced its at-home optical saliva fertility tester, Ovulation Scope for ovulation testing. Available for a suggested retail price of $26.99, Ovulation Scope will be available at K-Mart in March and Target in April, followed by additional retail channels in 3rd and 4th quarter 2003.
Affymetrix, Inc. has granted Roche Diagnostics non-exclusive access to its patented GeneChip brand technologies to develop and commercialize diagnostic products in a broad range of human disease areas, for up to 18 years. With these technologies, Roche Diagnostics will develop and market tests for a wide range of diseases such as cancer, osteoporosis, cardiovascular, metabolic, infectious diseases and inflammatory diseases.
Targeted Diagnostics & Therapeutics, Inc. has received FDA clearance to market its GCC-B1 blood test for the detection of recurrent colorectal cancer. The company reports that GCC-B1 can find 1 cancer cell in 10,000,000 normal cells by detecting the presence of guanylyl cyclase C (GC-C), which is found on metastatic colorectal cancer cells.
Varian, Inc. has acquired the non-clinical drugs of abuse testing (DAT) business of Roche Diagnostics Corporation for approximately $22 million in cash. Roche is retaining one strip-based DAT product, the TesTcard 9, sold to clinical laboratories, as well as its line of reagents designed for rapid instrument-based drug testing. Varian, Inc., through its 2002 acquisition of ANSYS Technologies, Inc., has been the contract manufacturer of the two primary Roche DAT product lines, the OnTrak TesTcup and OnTrak TesTstik, and the companies also collaborated on product design and development since the inception of the product line in the early 1990's.
Product developments - January 2003
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Last modified: March 3, 2003