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First CE marked FGF23 ELISA assay launched at Biomedica Immunoassays

The biomarker specialists at Biomedica Immunoassays, announced the launch of the first CE marked FGF23 (C-terminal) ELISA assay which specifically detects both intact and C-terminal fragments of FGF23 in human serum and plasma. The FGF23 ELISA assay complements the existing Biomedica assays directed against chronic kidney disease - mineral and bone disorder (CKD-MBD) in a growing collection.

24 Apr 2015

New patent-pending detection method identifies bacteria contaminating oysters

In a major breakthrough in shellfish management and disease prevention, researchers at the University of New Hampshire have discovered a new method to detect a bacterium that has contaminated New England oyster beds and sickened consumers who ate the contaminated shellfish.

23 Apr 2015

Data presented at AACR 2015 recognizes value of EKF PointMan technology for assessing lung cancer mutation status

The PointMan EGFR DNA enrichment kit, a novel method for selective amplification of genotype specific sequences.

From EKF Diagnostics 21 Apr 2015

Bio-Rad grants Beckman Coulter exclusive distribution rights for access HIV and Hepatitis C assays

Bio-Rad is extending its agreement with Beckman Coulter and has named the company exclusive global distributor of Bio-Rad’s Access HIV combo assay and the Access hepatitis C virus (HCV) assay in select geographies...

From Beckman Coulter Diagnostics 21 Apr 2015

Paradigm to provide PCDx test to oncologists in TD2 networks

Paradigm and Translational Drug Development today announced a partnership under which Paradigm will provide their PCDx test to TD2's affiliated oncology provider networks.

20 Apr 2015

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A.

From Baxter International Inc. 16 Apr 2015

Flagship Biosciences customizes assay development and tissue image analysis for advanced cell diagnostics RNAscope platform

Flagship Biosciences and Advanced Cell Diagnostics collaborate to develop quantitative RNAscope® assays for pharmaceutical clinical trials in the CLIA environment...

From Advanced Cell Diagnostics 16 Apr 2015

Focus Diagnostics announces FDA clearance for Simplexa Group A Strep Direct Kit

Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics, today announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit. Simplexa Group A Strep Direct is a real-time polymerase chain reaction assay for the detection of Group A Streptococcus bacteria directly from throat swabs.

From Quest Diagnostics 15 Apr 2015

Clyde Biosciences announces £2 million ‘Series A’ investment

Clyde Biosciences Ltd. has announced a £2 million ‘Series A’ investment led by Epidarex Capital, a leading international early-stage life science venture capital fund.

15 Apr 2015

iCardiac launches industry-first full risk-sharing program for cardiac safety studies

iCardiac Technologies, a market and scientific leader in the conduct of cardiac safety assessments, announced today that it has launched the industry’s first full risk-sharing program for Thorough QT studies. Leveraging its innovative High Precision QT™ methodology for analyzing ECG waveforms, iCardiac’s program guarantees to sponsors that one of two desirable outcomes will be achieved.

14 Apr 2015

Clyde Biosciences, a leading drug toxicity testing company, closes Series A investment

Clyde Biosciences Ltd. (Clyde Biosciences) has announced a £2 million ‘Series A’ investment led by Epidarex Capital, a leading international early-stage life science venture capital fund. Scottish Enterprise’s investment arm, the Scottish Investment Bank, also participated in the round along with Glasgow University Holdings, Ltd.

14 Apr 2015

Vermillion, Kaiser Permanente partner to enhance diagnosis, treatment of ovarian cancer

Vermillion, Inc., a bio-analytical solutions company focused on gynecologic disease, today announced the initiation of a strategic partnership with Kaiser Permanente's Southern California Permanente Medical Group in order to enhance the diagnosis and treatment of ovarian cancer.

14 Apr 2015

Researchers cultivate fully functional cardiac tissues from cobweb protein

Genetically engineered fibers of the protein spidroin, which is the construction material for spider webs, has proven to be a perfect substrate for cultivating heart tissue cells, MIPT researchers found. They discuss their findings in an article that has recently come out in the journal PLOS ONE.

13 Apr 2015

Inova Diagnostics gains FDA de novo clearance for NOVA View automated digital IFA microscope

Inova Diagnostics, the worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced today that the United States Food and Drug Administration has cleared NOVA View, an automated digital IFA (indirect fluorescent assay) microscope, through the de novo classification process.

12 Apr 2015

VolitionRx adds three new laboratory automation systems to expedite sample analysis for its large ongoing clinical trials

Using its first installed robot, VolitionRx has recently completed the analysis of a first NuQ® assay on the complete set of 4,800 blood samples for its large retrospective, symptomatic population colorectal cancer study in collaboration with Hvidovre Hospital, University of Copenhagen, Denmark.

10 Apr 2015

Scientists identify chemical compounds that block cancer-causing oncoprotein

A team of scientists at the University of Kansas has pinpointed six chemical compounds that thwart HuR, an "oncoprotein" that binds to RNA and promotes tumor growth.

10 Apr 2015

MammaPrint 70-gene breast cancer recurrence assay recommended in Germany’s AGO Guidelines

Agendia, a leading molecular diagnostics company that develops and markets genomic diagnostic products, announced at the St. Gallen International Breast Cancer Conference that new guidelines of the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) recommend the MammaPrint® 70-gene breast cancer recurrence assay in Germany’s 2015 guidelines for early-stage invasive breast cancer.

9 Apr 2015

Experimental oligonucleotide-based drug stimulates human immune system to fight infections

An experimental single-stranded oligonucleotide-based drug, MGN1703, comprised only of natural DNA components, stimulates the human immune system to fight infections and attack cancer cells without causing the harmful side effects associated with similar compounds that also contain non-natural DNA components.

8 Apr 2015

Sanford-Burnham, Daiichi Sankyo sign licensing agreement to expand development of small molecule

Sanford-Burnham Medical Research Institute today announced that it has signed a licensing agreement to further develop a first-in-class small molecule with Daiichi Sankyo for the treatment of cardiovascular-metabolic disease.

6 Apr 2015

Simple test outperforms current standard test for early-stage prostate cancer

A test that costs less than a $1 and yields results in minutes has been shown in newly published studies to be more sensitive and more exact than the current standard test for early-stage prostate cancer.

6 Apr 2015

Assay News and Research

First CE marked FGF23 ELISA assay launched at Biomedica Immunoassays

New patent-pending detection method identifies bacteria contaminating oysters

Data presented at AACR 2015 recognizes value of EKF PointMan technology for assessing lung cancer mutation status

Bio-Rad grants Beckman Coulter exclusive distribution rights for access HIV and Hepatitis C assays

Paradigm to provide PCDx test to oncologists in TD2 networks

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Flagship Biosciences customizes assay development and tissue image analysis for advanced cell diagnostics RNAscope platform

Focus Diagnostics announces FDA clearance for Simplexa Group A Strep Direct Kit

Clyde Biosciences announces £2 million ‘Series A’ investment

iCardiac launches industry-first full risk-sharing program for cardiac safety studies

Clyde Biosciences, a leading drug toxicity testing company, closes Series A investment

Vermillion, Kaiser Permanente partner to enhance diagnosis, treatment of ovarian cancer

Researchers cultivate fully functional cardiac tissues from cobweb protein

Inova Diagnostics gains FDA de novo clearance for NOVA View automated digital IFA microscope

VolitionRx adds three new laboratory automation systems to expedite sample analysis for its large ongoing clinical trials

Scientists identify chemical compounds that block cancer-causing oncoprotein

MammaPrint 70-gene breast cancer recurrence assay recommended in Germany’s AGO Guidelines

Experimental oligonucleotide-based drug stimulates human immune system to fight infections

Sanford-Burnham, Daiichi Sankyo sign licensing agreement to expand development of small molecule

Simple test outperforms current standard test for early-stage prostate cancer

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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