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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 May 2002
American Bio Medica Corporation has entered an agreement with American Bionostica Inc. to manufacture Rapid TB Test, a point of care assay for the rapid detection of tuberculosis. The test utilizes a lateral flow design, and has a unique antigen that allows the detection of human TB antibody present in humans infected with Mycobacterium tuberculosis. Bayer Diagnostics has received FDA clearance to market the Bayer Glucometer Elite, Glucometer Elite XL and Glucometer DEX/DEX 2 systems for the alternate site testing on forearm, palm, abdomen and thigh. BioCurex, Inc. has launched, Cryo-RECAF, its second product, based on the RECAF marker. The kit is designed for single patient use and is carried out on frozen sections of tissue material. The Cryo-RECAF assay provides a rapid method for staining cancer cells. Biomerica, Inc. has introduced the FDA approved, EZ-StrepA, a 5-minute disposable test that will determine the presence of Streptococcus A (Strep A) in the throat. The test is designed for physicians' offices and other point-of-care outlets. Bioplex Corp. has secured an exclusive license to Indiana University technology for the synthesis of optically encoded microbeads and nanobeads for human health applications, including drug discovery and clinical diagnostics. Bioplex has begun initial conversations with potential R&D partners in a variety of drug discovery and diagnostics applications. Cholestech Corporation has signed a multi-year agreement with Provalis Diagnostics Ltd., a division of Provalis plc for the global distribution of Provalis' Glycosal A1C testing and monitoring product which is CLIA waived Under the terms of the agreement, Cholestech will be a semi-exclusive partner for the product line, and will promote, distribute and sell Glycosal under Cholestech's trademark Cholestech GDX in the United States, Europe, Japan and throughout most of the rest of the world. Provalis has retained the right to sell Glycosal through its own sales division in the United Kingdom. Diametrics Medical, Inc. has signed an exclusive agreement with Biometric Imaging, Inc. for evaluation, licensing, and potential product development of Biometric's optical technologies to complement Diametrics' core optical and electrochemical biosensor technology platforms for point-of-care diagnostics. Fujirebio Diagnostics, Inc. has received FDA clearance to market its CA19-9 radioimmunoassay for monitoring of pancreatic cancer patients. IMI International Medical Innovations Inc. has signed an agreement with McNeil Consumer Healthcare, a Johnson & Johnson company, to market and distribute IMI's Cholesterol 1,2,3. The product is a non-invasive test that uses skin cholesterol to assess coronary artery disease risk. Under the agreement, McNeil gains exclusive rights for the Canadian market to both the professional skin cholesterol test system and the eventual home version, which will be jointly developed by McNeil and IMI. Immunicon Corporation was issued U.S. Patent 6,365,362 covering methods and reagents for the rapid and efficient isolation of circulating cancer cells in human subjects. The method described can detect one suspect cancer cell in a 1 mL sample of blood. The test will be marketed by Advanced Diagnostic Systems, a newly formed division of Ortho-Clinical Diagnostics, Inc. Invirion Inc. has introduced PAPStat, a specimen adequacy assay that enables physicians to determine, at the point of care, whether or not an adequate sample has been collected with the liquid-based Pap test. i-STAT Corporation has received FDA clearance to market its prothrombin time test used to monitor patients on anti-coagulant therapy, such as COUMADIN. Matritech Inc. and Bruker Daltonics Inc. have formed a partnership to develop an automated mass spectrometer system that will allow clinical laboratories to efficiently perform Matritech's proteomics-based cancer tests, including blood tests for breast and prostate cancer. Matritech's NMP66 breast cancer test and its NMP48 prostate cancer test will both be automated using the Bruker Daltonics system, with additional cancer tests to follow. The system will utilize MALDI-TOF mass spectrometry, automated sample handling, reagent kits and clinical bioinformatics. Meridian Bioscience, Inc. is buying Biotrin Holdings plc. Biotrin develops, manufactures and sells leading diagnostic tests for the identification of diseases and life science products used in pharmaceutical research. Annual worldwide revenues for Biotrin are about $7 million. Molecular Diagnostics, Inc. has received FDA clearance to market the InPath e2 Collector, a cervical sampling device that facilitates the collection of cells for Pap test analysis. The device has been cleared for use in conjunction with existing liquid preservatives. The e2 Collector can be used with the InPath POS test that is still in development or as a stand-alone product. Orchid BioSciences, Inc. has launched the LifeMatch platform in the US for human leukocyte antigen (HLA) genotyping and antibody detection. The LifeMatch system runs on the Luminex xMAP platform using reagents developed by Orchid. Ortho-Clinical Diagnostics has received FDA clearance to market the VITROS Anti-HCV assay, a random access diagnostic test for IgG antibody to the hepatitis C virus using the VITROS ECi Immunodiagnostic System. Prionics AG and PrioSense, a newly founded spin-off company of Hadasit at the Hadassah University Medical Centre in Jerusalem, have started the joint development of a live test for prion diseases. The test is based on the recent discovery of disease associated prion protein in the urine of both animals infected with BSE and humans infected with Creutzfeldt-Jakob Disease (CJD). QIAGEN N.V. has entered into an agreement to acquire GenoVision AS. The acquisition provides QIAGEN with automated solutions for the purification of nucleic acids based on GenoVision's proprietary magnetic particle technologies. GenoVision is focused on the development of reagents and solutions for certain nucleic acid diagnostic markets, such as the HLA market. QIAGEN and Roche Molecular Systems, Inc. have entered into a development, manufacturing and supply agreement for a customized integrated diagnostic system for use in the nucleic acid sample preparation, detection and quantification of the Hepatitis B, Hepatitis C and HIV-1 viruses based on Roche's PCR technology. Roche Molecular Diagnostics has received FDA clearance to market its automated PCR system, the COBAS TaqMan Analyzer. The COBAS TaqMan Analyzer is designed to automate PCR tests by first using the Roche COBAS AmpliPrep System to prepare PCR specimens and then employing the COBAS TaqMan System. Tm Bioscience Corporation is developing an array based Cystic Fibrosis test using their Universal Array technology on the Luminex xMAP system. The test will detect the 25 CF gene mutations recommended by The American College of Medical Genetics. Ventana Medical Systems Inc. is developing a diagnostic kit for use with the Novartis Pharmaceutical Corp. drug "Gleevec. Gleevec was first approved in 2001 by the FDA for use with chronic myeloid leukemia patients. The drug's labeling was extended in February 2002 for treatment of patients with c-kit positive inoperable and/or metastatic malignant gastrointestinal stromal tumors (GISTs). Ventana is collaborating with Novartis to develop a diagnostic kit for c-kit and file a Pre Marketing Approval (PMA) application with the FDA for the diagnostic.
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