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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 2004
Axis-Shield has received FDA clearance to market a B-type Natriuretic Peptide (BNP) test for use on Abbott's AxSYM automated immunoassay instrument system. In November 2003, Abbott introduced the test in major markets outside the United States and Japan. Beckman Coulter, Inc. has added to its cancer marker immunoassay panel. Two new markers were cleared for the US market - the Access GI Monitor measures levels of CA 19-9 that aids in the management of pancreatic cancer and the Access BR Monitor measures CA 15-3. CA 15-3 antigen levels are most commonly elevated in patients with breast cancer, but also can be present in patients with lung, ovarian, pancreatic and colorectal cancer, as well as non-malignant conditions such as benign breast and liver disease, cirrhosis and hepatitis. The company's tumor marker menu also includes the Hybritech PSA and Hybritech free PSA, tests for ovarian cancer; and tests for carcinoembryotic antigen (CEA) and alpha-fetoprotein (AFP). The tests are available on Beckman Coulter's Access and Access 2 immunoassay systems, the UniCel DxI 800 Access immunoassay system and SYNCHRON LXi 725 chemistry-immunoassay system. Bio-Rad Laboratories, Inc. has entered into a marketing agreement with Enzon Pharmaceuticals, Inc. to co-promote Bio-Rad's FDA approved Platelia Aspergillus EIA test kit in the US and Canada. The test is the only FDA-cleared method for diagnosing Invasive Aspergillosis and will be used in combination with Enzon's ABELCET antifungal drug. Biosite Incorporated announced that The Cleveland Clinic has granted the company certain diagnostic rights to myeloperoxidase (MPO), a marker of inflammation in the walls of coronary arteries. Under terms of the agreement, Biosite will have exclusive diagnostic rights for point-of-care testing and semi-exclusive diagnostic rights for automated testing. CellaVision AB has received FDA clearance to market the CellaVision DM96 automated digital cell morphology system, the next generation of the company's first product DiffMaster Octavia. The CellaVision DM96 locates and pre-classifies blood cells by means of automatic microscopy and advanced image processing, resulting in greater efficiency and standardization of the blood differential process. The product will be marketed by Sysmex America Inc. in the US. CombiMatrix signed a collaborative research agreement with Case Western Reserve University for work in developing a novel diagnostic for Alzheimer's disease using the CustomArray platform. DakoCytomation received FDA clearance to market its EGFR pharmDx kit as an aid in identifying colorectal cancer patients eligible for treatment with ERBITUX (cetuximab). In parallel, ImClone Systems' ERBITUX received approval for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer. DakoCytomation's kit identifies EGFR in tissue sections. EGFR is a protein expressed in a variety of cancers, including colorectal, lung, breast, pancreatic, bladder, prostate, kidney and head and neck. Fisher Scientific International Inc. announced that it plans to buy Oxoid Group Holdings Ltd. for $330 million, and Dharmacon Inc. for $80 million in cash. Oxoid makes products that test for bacterial contamination. Dharmacon develops RNA technologies used in life-science research. Guava is developing its PCA and PCA-96 cell analysis systems to perform blood typing and compatibility testing. The company plans to challenge Ortho Clinical Diagnostics ID-Micro Typing System. Haemonetics Corporation received from Hemosystem SA the exclusive sales and marketing rights for the Scansystem technology that screens blood components for bacteria. The Scansystem has CE Mark clearance for use in Europe on bacterial screening of platelets in less than 90 minutes. European evaluations with Scansystem are scheduled for early 2004. Hemosystem expects to submit an application for the Scansystem for use in bacterial detection of platelets to the FDA in 2004 and is developing the technology for use in the bacterial detection of red cells. Medtronic, Inc. has received FDA clearance to market the Guardian Continuous Glucose Monitoring System, a device designed to protect diabetes patients by alerting them to potentially dangerous fluctuations in glucose levels. Merck KGaA is selling its VWR International laboratory-distribution business to private equity firm Clayton, Dubilier & Rice Inc. for $1.68 billion. VWR will continue to distribute Merck laboratory products. Merck plans to combine its analytics & reagents and life science products divisions into a new Life Science & Analytics division, which will enter into a long-term agreement with VWR. Nanogen, Inc. has purchased SYN X Pharma, Inc. a point-of-care diagnostics company in an all-stock transaction by way of a court-approved plan of arrangement. Pall Corporation has received FDA clearance to market the Pall eBDS system, a Bacteria Detection System to detect bacteria in blood platelets. The Pall eBDS is the only system that can detect bacteria in all platelets whether derived from single donor or whole blood collection procedure. Quidel Corp. has received a CLIA waiver for the QuickVue influenza test A+B, which uses a nasal swab or nasal aspirate sample to assist in the diagnosis of acute influenza. Roche Diagnostics has granted Diagnostic Products Corporation a non-exclusive license for congestive heart failure marker, NT-proBNP (N-terminal prohormone brain natriuretic peptide). Sysmex Corporation subsidiary, Sysmex Corporation of America and the Diagnostics Division of Bayer HealthCare LLC signed a supply and distribution agreement for the sales and service of Sysmex's UF-100 fully automated urine cell analyzer and its associated products in the United States. Sysmex is responsible for manufacturing and supply, and Bayer Diagnostics is responsible for sales, marketing, and customer support of the product. The company's have also agreed that Sysmex will develop an automated conveyor transportation system that will move samples between the UF-100 to Bayer's Clinitek ATLAS automated urine chemistry analyzer. Sysmex America, Inc. has received FDA clearance to market the Sysmex pocH-100i, a compact complete blood count (CBC) and 3-part differential hematology analyzer. The analyzer targets the clinical laboratory and the physician office market.
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