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In Vitro Diagnostics News

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421-435 of 2990 results
Merck and Sysmex Inostics receive CE mark approval for liquid biopsy test for colorectal cancer patients
By MDBR Staff Writer
Merck, a leading science and technology company, announced that a new liquid biopsy RAS biomarker test, which they are co-developing and commercializing with Sysmex Inostics, has been granted CE Mark approval.
Diagnostics > In Vitro Diagnostics > News
Brazil’s Adavium Medical acquires two clinical diagnostic companies
By MDBR Staff Writer
Brazil-based Adavium Medical has acquired two clinical diagnostic companies Alka Tecnologia and Hemogram Industria e Comercio.
Diagnostics > In Vitro Diagnostics > News
Agena Bioscience introduces MassArray assays for lung and colon cancer
By MDBR Staff Writer
Agena Bioscience has introduced CE- IVD marked MassArray Dx in vitro diagnostic tests for lung and colon cancer in Europe.
Diagnostics > In Vitro Diagnostics > News
Medtronic receives expanded Indication Ffom FDA for Pillcam Colon 2 capsule
By MDBR Staff Writer
Medtronic announced that the US Food and Drug Administration (FDA) cleared PillCam COLON 2 capsule for an expanded indication for use.
Diagnostics > In Vitro Diagnostics > News
Thermo Fisher Scientific acquires Affymetrix for $1.3bn
By MDBR Staff Writer
Thermo Fisher Scientific has completed the acquisition of cellular and genetic analysis products provider Affymetrix, for around $1.3bn.
Diagnostics > In Vitro Diagnostics > News
Precision Biopsy submits IDE application to FDA to expand clinical trial of ClariCore Biopsy system
By MDBR Staff Writer
Precision Biopsy announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for permission to enroll patients in the Transrectal Ultrasound (TRUS) and MR/Fusion arm of the company’s study, expanding the scope of a clinical trial for its ClariCore™ Biopsy System in prostate cancer patients.
Diagnostics > In Vitro Diagnostics > News
Roche gets FDA approval to screen blood samples with cobas Zika assay
By MDBR Staff Writer
Roche has received approval from the US Food and Drug Administration (FDA) to start collection and testing of blood samples for screening with the cobas Zika assay under an investigational new drug application (IND) protocol.
Diagnostics > In Vitro Diagnostics > News
Great Basin receives FDA 510(k) clearance for first multiplex panel
By MDBR Staff Writer
Great Basin Scientific, a molecular diagnostics company, has received US Food & Drug Administration (FDA) 510(k) clearance for its Staph ID/R Blood Culture Panel, following submission in August 2015.
Diagnostics > In Vitro Diagnostics > News
Fluxion launches BioFlux extended flow module
By MDBR Staff Writer
Fluxion Biosciences announced that it has launched its BioFlux Extended Flow module for live cell analysis. The module consists of a new 6-well plate consumable and interface; it is now available and shipping to customers.
Diagnostics > In Vitro Diagnostics > News
Luminex wins CE-IVD mark approval for Aries system and HSV 1&2 assay
By MDBR Staff Writer
US-based biotechnology company Luminex has secured CE-IVD mark approval for Aries system and Aries HSV 1&2 assay.
Diagnostics > In Vitro Diagnostics > News
Transgenomic introduces new test to detect EGFR C797S mutations
By MDBR Staff Writer
Transgenomic has introduced a new test to identify the presence of the EGFR C797S mutation that is related with resistance to new third-generation tyrosine kinase inhibitor (TKI) therapies in development for non-small cell lung cancer (NSCLC).
Diagnostics > In Vitro Diagnostics > News
Origin Technologies offers $1.5bn to acquire Affymetrix
By MDBR Staff Writer
Origin Technologies has offered around $1.5bn to acquire US-based medical technology firm Affymetrix, topping a $1.3bn bid from Thermo Fisher Scientific.
Diagnostics > In Vitro Diagnostics > News
Helomics launches GeneFx Colon to identify patients with high risk stage II colon cancer
By MDBR Staff Writer
Helomics, a privately-held, personalized healthcare company that provides comprehensive tumor profiling utilizing proprietary tissue-based live cell and fixed cell products and services, announced the launch of GeneFx Colon, a prognostic multi-gene expression assay designed to identify colon cancer patients who are likely to experience recurrence within five years following initial surgery.
Diagnostics > In Vitro Diagnostics > News
Researchers develop new medical device for health check-up in space
By MDBR Staff Writer
Researchers from the NASA’s Ames Research Center, the University of California, Davis and Sandia National Laboratories/California and Lawrence Livermore National Laboratory (LLNL) have developed a new medical device for health check-up in deep space.
Diagnostics > In Vitro Diagnostics > News
Roche introduces new chromogen for cancer research
By MDBR Staff Writer
Roche has expanded its Ventana modular-based detection kits with the introduction the new Discovery Yellow kit for cancer research.
Diagnostics > In Vitro Diagnostics > News
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