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In Vitro Diagnostics News

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481-495 of 2993 results
Shire partners with CrowdMed to offer US employees innovative digital crowdsourcing diagnostic service
By MDBR Staff Writer
Shire announced an innovative partnership with CrowdMed, a Web-based technology that harnesses "the wisdom of crowds" to solve difficult medical cases online.
Diagnostics > In Vitro Diagnostics > News
Meridian’s Bioline introduces new JetSeq DNA library preparation kit
By MDBR Staff Writer
Meridian Bioscience wholly-owned subsidiary Bioline has introduced JetSeq DNA library preparation kit, the first product in a new line of the firm’s kits for next-generation sequencing (NGS) sample preparation.
Diagnostics > In Vitro Diagnostics > News
Cepheid obtains FDA 510(k) approval for Xpert Flu+RSV Xpress test
By MDBR Staff Writer
Molecular diagnostics firm Cepheid has received 510(k) approval and clinical laboratory improvement amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its Xpert Flu+RSV Xpress test for use on GeneXpert Xpress system.
Diagnostics > In Vitro Diagnostics > News
DNAe expands US operations with clinical diagnostic development and manufacturing site in San Diego
By MDBR Staff Writer
DNA Electronics (‘DNAe’), the inventors of semiconductor DNA sequencing technology and developers of a new, revolutionary point-of-need test for bloodstream infections, will expand and relocate its US operations from Albuquerque, NM to San Diego, CA.
Diagnostics > In Vitro Diagnostics > News
HiberGene receives CE-IVD mark approval for meningitis test
By MDBR Staff Writer
HiberGene Diagnostics has received CE-IVD mark approval for its HG Meningococcus test, which enables physicians to discover the presence of meningococcal bacteria in patients.
Diagnostics > In Vitro Diagnostics > News
Portuguese firm Biosurfit secures EIB fund to develop novel diagnostic tests
By MDBR Staff Writer
Portuguese point-of-care (PoC) diagnostics firm Biosurfit has secured a €12m fund from the European Investment Bank (EIB) to carry out R&D activities in medical diagnostics.
Diagnostics > In Vitro Diagnostics > News
SkylineDx’s MMprofiler prognostic test wins CE-IVD mark approval for multiple myeloma
By MDBR Staff Writer
Biotech firm SkylineDx has received CE-IVD mark approval from the European Competent Authority for its MMprofiler prognostic test to determine the level of risk of a patient with multiple myeloma.
Diagnostics > In Vitro Diagnostics > News
Alere completes divestiture of BBI Group
By MDBR Staff Writer
Alere, a global leader in rapid diagnostics announced today the completion of the previously announced sale of its BBI business to Exponent Private Equity, a UK-based private equity firm.
Diagnostics > In Vitro Diagnostics > News
Meridian receives FDA clearance for new molecular whooping cough test claims
By MDBR Staff Writer
Meridian Bioscience announced it has received clearance from the U.S. Food and Drug Administration (FDA) for new claims for its illumigene Pertussis molecular amplification test.
Diagnostics > In Vitro Diagnostics > News
Pfizer, Novartis, Thermo Fisher Scientific partner to develop NGS oncology test
By MDBR Staff Writer
Thermo Fisher Scientific has partnered with drugmakers Novartis and Pfizer to develop next-generation sequencing-based (NGS) companion diagnostic (CDx) test.
Diagnostics > In Vitro Diagnostics > News
Roche’s new test wins FDA approval as companion diagnostic for NSCLC therapies
By MDBR Staff Writer
Switzerland’s Roche has received approval from the US Food and Drug Administration (FDA) for its cobas epidermal growth factor receptor (EGFR) mutation test v2 as a companion diagnostic for non-small cell lung cancer (NSCLC) therapies.
Diagnostics > In Vitro Diagnostics > News
Rosetta provides update on performance data and launch of RosettaGX Reveal
By MDBR Staff Writer
Rosetta Genomics announces additional performance data from the recently-completed, blinded validation study of RosettaGX Reveal, its microRNA-based diagnostic assay for the classification of indeterminate thyroid nodules.
Diagnostics > In Vitro Diagnostics > News
Roche launches new H&E tissue staining solution
By MDBR Staff Writer
Roche announced the launch of the VENTANA HE 600 system, the latest fully automated hematoxylin and eosin (H&E) tissue staining system that enhances patient and technician safety and produces exceptional staining quality.
Diagnostics > In Vitro Diagnostics > News
Thermo Fisher Scientific reveals results of prostate cancer screening study
By MDBR Staff Writer
Thermo Fisher Scientific, along with Karolisnka Institute, has revealed the results of the Stockholm 3 (STHLM3) clinical study, designed to develop an effective test to screen prostate cancer than using the prostate-specific antigen (PSA) alone.
Diagnostics > In Vitro Diagnostics > News
Roche expands cobas 4800 system menu with HIV-1, HCV and HCV genotyping tests
By MDBR Staff Writer
Roche announced the commercial availability of the cobas HIV-1, HCV and HCV genotyping (GT) assays in countries accepting the CE mark.
Diagnostics > In Vitro Diagnostics > News
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