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 2005
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Accumetrics' VerifyNow Aspirin Test has been granted a CLIA waiver by the FDA. The test provides a rapid result that identifies a patient's responsiveness to aspirin therapy.
BioArray Solutions, Ltd. is developing the HEA (Human Erythrocyte Antigen) BeadChip Test that includes 18 human erythrocyte antigens other than those in ABO and Rh antigen groups and including those in the Duffy, Kell, Kidd, Lutheran, MNS, Dombrock and a mutation associated with sickle cell disease. The assay format employs a single tube multiplex PCR amplification.
bioMérieux SA has acquired an option to license Applied NeuroSolutions' Alzheimer's disease tests. bioMérieux will be financially responsible for securing regulatory approvals to develop and sell diagnostic tests based on Applied Neurosolutions' research on a blood test.
Correlogic Systems, Inc. entered into a research collaboration with the Uniformed Services University of the Health Sciences and the Henry M. Jackson Foundation for the Advancement of Military Medicine whereby USU's Center for Prostate Disease Research and the Foundation will collaborate with Correlogic on a study on the use of Correlogic's protein pattern recognition approach and technology in prostate cancer. The goal is to develop a more effective blood test for the detection of prostate cancer.
DexCom Inc. announced that its PMA for the DexCom Short-Term Continuous Glucose Sensor submitted in March 2005 has been accepted and granted expedited review status.
Glycominds was awarded the CE MARK for its IBDX products, a series of blood tests for Crohn's Disease, enabling differential diagnosis between Crohn's disease, ulcerative colitis and irritable bowel syndrome.
Inverness Medical Innovations acquired Abbott Diagnostics' Determine/DainaScreen assets which provide rapid qualitative results for infectious diseases, including hepatitis, HIV and syphilis. Under the terms of the agreement Inverness will acquire the Determine/DainaScreen rapid diagnostics menu for $56.5 million. The assets include manufacturing equipment, and certain transferred and licensed intellectual property related to the products. Abbott will continue to distribute the Determine products, which are marketed outside of the United States, for up to 32 months and will receive a sales commission on net sales. Under a long term supply arrangement Inverness will sell product to Abbott which will allow Abbott to continue to distribute the Determine HIV 1/2 rapid test at no profit to Abbott through the Abbott Access to HIV Care program in 69 developing countries.
Inverness Medical Innovations' subsidiary, Wampole Laboratories, LLC, signed an agreement with ThyroTec Inc. to serve as the exclusive North American distributor of ThyroTest, a rapid immunoassay screen for TSH in whole blood. ThyroTest is the first rapid format TSH test to receive FDA clearance and CLIA waiver.
SomaLogic, Inc., entered a technology development agreement with Quest Diagnostics Incorporated to develop new diagnostic tests based on SomaLogic's aptamer array platform in the areas of oncology, as well as cardiovascular, autoimmune, and infectious diseases. In addition, Quest Diagnostics has made a $15 million equity investment in SomaLogic.
Tessera Inc. in collaboration with the Brady Urological Research Institute at Johns Hopkins University is developing blood tests for prostate and colon cancer. The company is begining with EPCA (Early Prostate Cancer Antigen).
Product developments - April 2005
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Last modified: June 6, 2005