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Roche Molecular Systems receives FDA clearance for new LightCycler MRSA Advanced Test

Roche Molecular Systems, Inc. announced today that the U.S. Food & Drug Administration (FDA) cleared its new LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the United States.

9 Jul 2010

MicroRNAs accurately identify four histological types of renal tumors: Study

Rosetta Genomics, Ltd., a leading developer and provider of microRNA-based molecular diagnostics, announces that a peer-reviewed article entitled "Accurate Molecular Classification of Renal Tumors Using MicroRNA Expression" has been published in the online version of The Journal of Molecular Diagnostics.

7 Jul 2010

QIAGEN receives CE conformity marking for careHPV Test

QIAGEN has completed European certification of its careHPV™ Test to bring human papillomavirus (HPV) testing to public-health programs in low-resource, developing countries, the company announced today at the International Papillomavirus Conference in Montreal, Canada. The CE conformity marking ("Conformite Europeenne") certifies that the careHPV Test has met European Union consumer safety and health requirements, allowing the test to be distributed in developing countries that recognize the CE mark.

From QIAGEN Manchester Limited 7 Jul 2010

USPTO grants Vermillion Alzheimer's disease biomarker patent

Vermillion, Inc., a molecular diagnostics company, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance of a patent entitled "Biomarkers for Alzheimer's disease" to the Company.

29 Jun 2010

AMP comments on barriers to market for molecular diagnostic tests at FDA CDRH meeting

Yesterday, the Association for Molecular Pathology (AMP) gave public comments at the FDA's Center for Devices and Radiological Health (CDRH) Council meeting on Medical Device Innovation: Barriers to Market for Molecular Diagnostic Tests.

28 Jun 2010

PGXL announces new contractual agreement with GH

PGXL, a Louisville-based molecular diagnostics laboratory, announced a new contractual agreement with Generation Health, Inc. The agreement makes PGXL a preferred genetic testing lab for GH. The lab will provide molecular diagnostic tests for GH, which will help physicians make therapeutic decisions and facilitate what has come to be known as "personalized medicine."

25 Jun 2010

Researchers develop new assay test for bladder cancer

Researchers from the Danish Cancer Society and the Herlev University Hospital of Copenhagen have developed a novel assay to test for multiple tumor markers in bladder cancer.

25 Jun 2010

OvaGene Oncology opens new advanced molecular research and clinical laboratory facility

OvaGene Oncology Inc., a biotechnology company specializing in the development and commercialization of personalized DNA-based diagnostics for gynecologic cancer, announced today the opening of its new clinical and research laboratory in Irvine, California. This state-of-the-art facility will serve as the central headquarters for operations, research, and molecular clinical lab testing.

23 Jun 2010

Biodesix awarded US patent for VeriStrat serum test

Biodesix, Inc., a company developing and commercializing molecular diagnostics for personalized medicine, announced today that the United States Patent and Trademark Office has awarded to the Company patent number 7,736,905. The patent provides coverage for the Company's first product, VeriStrat®, which is used by physicians to help guide therapy for patients with advanced lung cancer. The allowed claims are directed towards the serum-based identification of patients likely to benefit from epidermal growth factor targeted therapy.

22 Jun 2010

Exiqon licenses LNA technology to BD for diagnosing infectious diseases

Exiqon A/S, today announced that it has granted a non-exclusive license to BD to use Exiqon's proprietary locked nucleic acids technology in defined products for infectious disease diagnostics.

From BD (Becton, Dickinson and Company) 21 Jun 2010

Gen-Probe invests $50M in Pacific Biosciences

Gen-Probe Incorporated and Pacific Biosciences announced today that Gen-Probe has made a $50 million strategic investment in Pacific Biosciences, a private sequencing company. In addition, the companies will work together to explore co-development of new integrated clinical diagnostics systems based on Pacific Biosciences' Single Molecule Real Time (SMRT™) platform and Gen-Probe's expertise in diagnostics.

18 Jun 2010

CLC bio headed molecular diagnostics project receives $2M grant

CLC bio, Ion Torrent, and Aarhus University Hospital - Departments of Molecular Medicine and Clinical Genetics, have received a 2 million USD grant from the Danish National Advanced Technology Foundation.

15 Jun 2010

SIRS-Lab, Analytik Jena partner in molecular sepsis diagnostics

SIRS-Lab GmbH and Analytik Jena AG, also based in Jena, will be strengthened by working together in the field of molecular sepsis diagnostics. As part of this cooperation, Analytik Jena subsidiary AJ Innuscreen GmbH will provide the partner with a platform for automated isolation of nucleic acids with the associated reagent system worth almost half a million euro.

15 Jun 2010

Desert Medical Imaging to implement XIFIN's revenue cycle management system

XIFIN Inc., the leading provider of revenue cycle management for diagnostic service providers, announced today that Desert Medical Imaging, (DMI) a multi-modality diagnostic imaging center located in Indian Wells, CA, has selected XIFIN's revenue cycle management system to optimize and help manage its expanding imaging and radiology billing and claims management needs.

14 Jun 2010

Roche's new dual-PCR target HIV-1 viral load test receives FDA approval

Roche Molecular Diagnostics announced today that the Food and Drug Administration (FDA) approved its new dual-PCR target HIV-1 viral load test to quantify the amount of virus in a patient's blood. The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is the first quantitative viral load test to amplify and detect two separate regions of a target genome and offers a fully automated and reliable solution for physicians to make informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy.

4 Jun 2010

Asuragen obtains license to integrate BRAF V600E mutation sequence into its molecular diagnostic products

Asuragen, Inc., a leader in molecular diagnostics and RNA-based pharmacogenomics services, announced today that it has obtained a non-exclusive license to incorporate the BRAF V600E mutation sequence into Asuragen's molecular diagnostic products. The license was obtained from Johns Hopkins University and includes the use of the BRAF V600E mutation as a component of diagnostic test kits and for use in Asuragen's CLIA laboratory for clinical research and patient testing.

2 Jun 2010

Helicos BioSciences to focus business on diagnostics markets

Helicos BioSciences Corporation announced today that, as part of the Company's previously disclosed efforts to consider alternatives to its existing long-term strategy, it is in the process of implementing a strategic shift to focus the business on the diagnostics markets. In connection with this effort, the Company has committed to a consolidation and reorganization of its operations in order to reduce operating costs.

18 May 2010

Caliper to sell RapidTrace solid phase extraction and TurboVap evaporation product lines to Biotage for $16.5M

Caliper Life Sciences, Inc., a leading provider of tools and services for drug discovery and life sciences research, today announced that it reached an agreement to sell its RapidTrace® solid phase extraction and TurboVap® evaporation product lines to Biotage AB for $16.5 million in cash.

18 May 2010

GE Healthymagination Fund invests $5M in CardioDx

GE Healthcare, the healthcare business of GE and CardioDx, a pioneer in cardiovascular genomic diagnostics, announced today that the companies have entered into a strategic alliance to advance and co-develop diagnostic technologies to improve the care and management of patients with cardiovascular disease.

14 May 2010

LifeCodexx AG develops test using Next Generation Sequencing technologies for prenatal diagnostics

LifeCodexx AG has started operational research and development work on clinically validated diagnostic tests by using Next Generation Sequencing technologies. The work currently focuses on the field of prenatal diagnostics.

12 May 2010