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AMSBIO Has Launched CancerSeq

Feb 27, 2014

AMSBIO has launched CancerSeq™ - a new range of genetically characterised FFPE tissue samples. CancerSeq™ samples are prepared from genomic DNA extracted from the FFPE tumour tissues and validated by Next Generation ...

Tags: Cancer, DNA, Genomics, Protein

Update on Her2/Neu (4b5) Rabbit Monoclonal Primary Antibody Assay Is Provided by Ventana

Dec 17, 2013

Ventana Medical Systems (Ventana), a member of the Roche Group, has announced that its Ventana HER2/neu (4B5) rabbit monoclonal primary antibody assay is now a companion diagnostic for detecting HER2 protein expression for patients who, in ...

Tags: Ventana, Medical Systems

NanoString Announced The Availability of The Ncounter Dx Analysis System

Nov 14, 2013

NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has announced the availability of the nCounter Dx analysis system for high-complexity, CLIA-certified laboratories. ...

Tags: NanoString, DX Analysis System

MetaStat Announced Women's Breast Cancer Has Confirmed

Oct 10, 2013

US-based MetaStat has announced that a study of 481 women with breast cancer has confirmed that the MetaSite Score (a count of the number of TMEM structures) was found to be associated with a statistically significant increase in the risk ...

Tags: MetaStat, Breast Cancer

510(K) Clearance for Prosigna Assay Is Obtained by Nanostring Technologies

Sep 12, 2013

NanoString Technologies, a provider of life science tools for translational research and molecular diagnostic products, has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its Prosigna breast cancer prognostic gene ...

Tags: NanoString Technologies, Prosigna Assay

NMR-Based Tmao Assay Is Expected to Detect Future Cardiovascular Risks

May 2, 2013

Diagnostic company LipoScience has begun the clinical development phase of a diagnostic test based on the gut flora metabolite, trimethylamine-N-oxide (TMAO). The nuclear magnetic resonance (NMR)-based TMAO assay is expected to detect ...

Tags: Liposcience, Clinical Development

MolecularMD Has Obtained a License in Non-Small Cell Lung Cancer Patients

Jan 30, 2013

MolecularMD has obtained an exclusive license to LKB1 for diagnostic, prognostic and predictive uses in non-small cell lung cancer patients. The Dana-Farber Cancer Institute, the Massachusetts General Hospital, the University of North ...

Tags: MolecularMD, exclusive license, lung cancer patients

UFDA Now Can Design for The Detection of Toxigenic C Difficile Bacterial Dna.

Dec 19, 2012

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA. The AmpliVue C. ...

Tags: FDA, Non-Instrumented C Difficile Detection Assay, medical technology

The European Union Has Granted CE Mark to Abacus Diagnostica's Molecular Diagnostic Assay

Dec 18, 2012

The European Union has granted CE mark to Abacus Diagnostica's molecular diagnostic assay, designed for detecting toxin-producing Clostridium difficile. The GenomEra C. difficile assay, which is designed for use with the company's ...

Tags: CE Mark, molecular diagnostic assay

IntelligentMDx Received CE Mark Approval for Its Automated Molecular HSV-1/2 Test

Dec 7, 2012

IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system. The HSV-1/2 for Abbott m2000 assay detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and ...

Tags: IntelligentMDx, HSV-1/2 test, Abbott m2000 system, HSV

Rheonix Will Present Data of Its Automated KRAS CARD Molecular Diagnostic Assay

Dec 7, 2012

Rheonix, a developer of molecular diagnostic platforms, will present data of its automated KRAS CARD molecular diagnostic assay. The KRAS CARD is designed to detect seven known somatic mutations of KRAS oncogene from either fresh or ...

Tags: Rheonix, KRAS CARD, diagnostic assay, KRAS assay

Nicox Has Announced The US Launch of Its Rapid Point-of-Care Diagnostic Test

Oct 23, 2012

Nicox has announced the US launch of its rapid point-of-care diagnostic test, designed for the detection of acute conjunctivitis. The FDA-cleared and CLIA-waived assay, AdenoPlus, uses its four-step process to detect adenovirus and ...

Tags: rapid point-of-care diagnostic test, FDA, medical devices

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