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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 March 2006
Abbott Diabetes Care received FDA clearance to market its FreeStyle Freedom blood glucose monitoring system for consumer use. FreeStyle Freedom measures glucose levels using a very small blood sample size (0.3 micro liter) and allows people to test on less sensitive parts of the body such as the forearm, thigh and palm. Aureon Laboratories launched Prostate Px, a predictive test that can provide personalized determination of the risk for prostate cancer recurrence following removal of the prostate. The Prostate Px score detects the probability of PSA Recurrence (bio-chemical recurrence) and Clinical Failure (distant metastasis) using the formalin-fixed, paraffin-embedded tissue from the patient's prostate. Beckman Coulter received FDA clearance to market its chemistry-immunoassay workstation, the UniCel DxC 600i Synchron Access clinical system -- has been cleared by the U.S. Food and Drug Administration. It will be available for shipment in mid-2006. Biophysical Corporation has developed a blood test that stacks commonly used biomarkers such as cholesterol, LDL and HDL and other specialized and emerging biomarkers (39 in total) to evaluate cardiovascular disease. Eli Lilly and Company and Biosite are collaborating in a clinical trial for Lilly's severe sepsis drug, Xigris. The trial, called RESPOND (Research Evaluating Serial Protein C levels in severe sepsis patients ON Drotrecogin alfa), will investigate the use of a multipurpose biomarker, Protein C, to be used in connection with the administration of Xigris. Bruker Daltonics introduced its MALDI BioTyper system for the identification and classification of microorganisms using protein fingerprints measured by MALDI-TOF mass spectrometry. The MALDI BioTyper measures high-abundance proteins, including many ribosomal proteins to determine the expression patterns of bacteria, yeasts and fungi. DexCom received FDA clearance to market its STS Continuous Glucose Monitoring System. About the size of a ball-point pen cap, the device is injected into the arm or the stomach, where it stays near the surface of the skin and is held in place by adhesive tape. The system can be used to treat both Type I and Type II diabetes and can be used for three days. An FDA application for a seven-day version of the device is pending. Fisher Scientific is buying Athena Diagnostics, a provider of proprietary molecular diagnostic and immunodiagnostic tests and services, from Behrman Capital for $283 million in cash. Athena had 2005 net revenues of $55 million. Fisher also entered into an agreement to purchase 9% of Nanogen for $15 million in cash. Fisher and Nanogen will collaborate to expand the use of Athena's proprietary markers and tests. GenExel-Sein received FDA clearance to market the Duo-Care, a device that combines a home-use blood glucose and wrist blood pressure monitor in one device. Nanogen received FDA clearance to market its StatusFirst CHF NT-proBNP EDTA plasma test to aid in the diagnosis of individuals suspected of having congestive heart failure (CHF). The test was produced in collaboration with Princeton BioMeditech Corporation. PBM will manufacture the product under contract with Nanogen. The test is sold in conjunction with the DXpress reader, a qualitative and quantitative instrument supplied by PBM. Polymedco announced that five tests - total cholesterol, triglycerides, HDL, glucose, and ALT - have been granted Waived status for the SPOTCHEM EZ analyzer, supplied by ARKRAY. Proteome Systems and Egenix agreed to co-develop a semen-based diagnostic kit for prostate cancer based on the known proprietary Human Carcinoma Antigen (HCA). Signet Laboratories and AsymmetRx launched their patented, FDA cleared Prostate-63 Prostate Cancer Diagnostic Test Kit using p63. The test, exclusively marketed by Signet Laboratories, is the first in a series of kits that uses p63 to diagnose prostate cancer.
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