Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Videos
Diagnostics
In Vitro Diagnostics
Return to: MDBR Home | Diagnostics | In Vitro Diagnostics | News
Search Refinements

In Vitro Diagnostics News

View news from other Medical Devices sectors:
421-435 of 2993 results
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
Roche receives approval in Japan for the cobas EGFR Mutation Test v2
By MDBR Staff Writer
Roche announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved the cobas EGFR Mutation Test v2 for diagnostic use.
Diagnostics > In Vitro Diagnostics > News
Cepheid’s Xpert Carba-R test gets FDA approval to detect carbapenem resistance genes
By MDBR Staff Writer
Molecular diagnostics firm Cepheid has secured approval from the US Food and Drug Administration (FDA) for its qualitative in vitro diagnostic test, Xpert Carba-R.
Diagnostics > In Vitro Diagnostics > News
GenomeDx Biosciences launches Decipher Biopsy test
By MDBR Staff Writer
GenomeDx Biosciences announced the launch of Decipher Biopsy, a genomic test that evaluates RNA expression-based biomarkers to predict the risk of high-grade disease, metastasis and cancer-specific death at the time of biopsy in men with prostate cancer.
Diagnostics > In Vitro Diagnostics > News
SeraCare launches circulating tumor DNA reference materials for NGS and digital PCR-based oncology assays
By MDBR Staff Writer
SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers, announces the launch of two new circulating tumor DNA (ctDNA) products at the 2016 Molecular Medicine Tri-Conference in San Francisco.
Diagnostics > In Vitro Diagnostics > News
Thermo Fisher Scientific announces expanded FDA clearance for its B•R•A•H•M•S PCT sepsis biomarker
By MDBR Staff Writer
Thermo Fisher Scientific, the world leader in serving science, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) that expands the clinical claims of the Thermo Scientific B•R•A•H•M•S PCT (procalcitonin) biomarker assay for sepsis risk assessment. PCT is a sensitive and specific biomarker of systemic bacterial infection.
Diagnostics > In Vitro Diagnostics > News
421-435 of 2993 results