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Biophage Pharma Inc. is developing BacTrapping system, a platform for the selective isolation and concentration of bacteria based on the unique properties of natural phages. The system can be used alone or in combination with the company's PDS Biosensor. The Biosensor can detect 5-10 bacteria in a 1 mL sample without any pre-enrichment and can simultaneously screen up to 60 samples for different types of bacteria.
Diazyme Laboratories received FDA clearance to market its Enzymatic Total Bile Acids Assay Kit for the quantitative determination of total bile acids in human blood samples. Total bile acids are elevated in patients with acute hepatitis, chronic hepatitis, liver sclerosis, and liver cancer and are a sensitive indicator for monitoring the effectiveness of interferon treatment of chronic hepatitis C patients.
E-Z-EM, Inc. and Nova Biomedical are developing the EZ CHEM blood analyzer. E-Z-EM has exclusive rights to market the product to radiologists and gastroenterologists in North America, with additional marketing rights worldwide. The system will be used to evaluate a patient's kidney function before receiving IV contrast prior to a CT exam.
Inverness Medical Innovations, Inc. received FDA clearance to market its Albumin Cobalt Binding test for detection of Ischemia Modified Albumin (IMA) on the Roche Diagnostics Corporation Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems. IMA is a key marker of cardiac ischemia.
IPGDx has developed PrognostiCheck, a noninvasive device to aid in end of life treatment decisions. The device captures and reports a basic level of cellular physiology, illustrating the plasma cell membrane. The test is repeated over time to track the dynamic changes in each patient in order to optimize treatment and also to recognize when treatment may no longer be effective.
MonoGen, Inc. received FDA clearance to market its MonoPrep Pap Test. The FDA specified that the MonoGen premarket approval application is approvable subject to a satisfactory outcome from the inspection of the company's manufacturing facilities and final agreement on labeling.
Nanogen, Inc. is buying Spectral Diagnostics' rapid cardiac immunoassay test business, including the cardiac STATus, Decision Point and i-Lynx product lines for CDN$9 million. Nanogen will assume related sales, marketing and manufacturing activities. The transaction is expected to close during the first quarter of 2006.
Oxford Immunotec's T SPOT-TB tuberculosis test has been approved for use in Europe. The test is expected to replace the century old tuberculin skin test, the oldest diagnostic test still in use today.
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