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 2002
Abbott Labs has been awarded a multi-year contract as the exclusive supplier of six infectious disease tests used for screening blood donated to the American Red Cross. The tests include markers for hepatitis, HIV and other retroviruses.
Bio-Rad Laboratories has acquired Quantase Ltd., a company specializing in newborn screening diagnostic products. Terms of the acquisition were not disclosed. This acquisition adds to Bio-Rad's newborn screening tests for Phenylketonuria, Galactosemia, Glucose-6-Phosphate Dehydrogenase (G-6-PD) Deficiency and DNA, immunoassay and HPLC-based tests for sickle cell anemia, metabolic disorders, and thalassemia.
BioSource has launched an immunoassay to detect and quantify levels of p38 MAPK, a protein in drug discovery research focused on mitogen activated protein kinases (MAPK). Pharmaceutical companies are studying p38 MAPK modifiers as drug candidates for several types of cancer, Parkinson's Disease, diabetes, and cardiovascular disease.
DAKO A/S and Bayer Diagnostics have signed a global distribution agreement for the oncology ELISA assays developed and manufactured by Bayer Diagnostics' Oncogene Science Group. They include tests for the shed extra-cellular domain of the HER-2/neu oncoprotein (HER-2/neu ECD), Epidermal Growth Factor Receptor (EGFr), urokinase plasminogen activator (uPA), plasminogen activator inhibitor-1 (PAI-1), and an assay that detects the complexes between uPA and PAI-1.
DAKO A/S is merging with Cytomation, Inc. and plan to combine their operations to form a new holding company -- DAKO Cytomation A/S. The new company combines Cytomation's core strengths in high-performance cell separation bioinstrumentation and software with DAKO's expertise in biotech and diagnostic applications.
diaDexus, Mayo Clinic, and Mayo Medical Laboratories have entered into a collaborative agreement to explore the clinical applications for PLAC Test, (Lp-PLA2) a test that detects a newly identified independent risk factor for cardiovascular disease. The test was developed by diaDexus for patients who do not exhibit traditional risk factors such as elevated cholesterol, high blood pressure or diabetes.
The FDA has rejected Digene Corp's premarket approval supplement application to market its human papillomavirus (HPV) DNA test in conjunction with a Pap smear as a primary screening tool for cervical cancer. An FDA advisory panel conditionally supported approval of the DNA Pap test in early March, but the agency has requested additional data and analyses to support the primary screening indication.
TriPath Imaging and Digene Corp. have filed a Pre-Market Approval Supplement application with the FDA for approval to use the company's SurePath Test Pack as a specimen collection medium for Digene's Hybrid Capture 2 (hc2) HPV DNA Test. The SurePath System is a liquid based cytology collection, preservation and transport system for the preparation of thin-layer slides for cervical cancer screening.
Diagnostic Products Corporation has released an automated version of Matritech's NMP22 test for bladder cancer to be performed on DPC's IMMULITE analyzer. NMP22 becomes the first and only fully automated bladder cancer test.
LifeScore has added the CancerSafeScore to its list of preventive healthcare services. CancerSafeScore is a special blood test that can detect cancer at its earliest stages. Developed by Cancersafe and Chaperon-Tarbouriech Laboratory in Switzerland and France, the test has been available in Europe.
Sigma-Aldrich Corporation has decided to sell substantially all of the assets of its diagnostics business and to continue to supply customers under contract while seeking to transfer these commitments to other vendors as it seeks to discontinue this business before the end of 2002. Certain catalog-based products marketed by the diagnostics unit that contributed $11 million in sales and provided a modest positive contribution to diluted earnings per share in 2001 were reclassified out of Diagnostics and into the company's Scientific Research unit. All remaining assets of the Diagnostics business are available for sale.
Trinity Biotech has received FDA clearance to market its automated D-dimer test, AutoDimer. This approval will enable the company to offer three FDA cleared tests to confirm the presence of blood clots - AutoDimer, Miniquant and Minutex. Biopool launched the AutoDimer test outside the USA in Q1 2000.
Product developments - March 2002
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Last modified: May 01, 2002