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In Vitro Diagnostics News

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571-585 of 2993 results
MolecularMD receives New York State approval for next generation sequencing test
By MDBR Staff Writer
MolecularMD, a molecular diagnostics company that provides companion diagnostic solutions and supporting clinical trial testing services for targeted cancer therapies, received approval from the New York State Department of Health (NYDOH) for its Next Generation Sequencing (NGS) Notch 1 gene mutation analysis in FFPE tissue and whole blood specimens.
Diagnostics > In Vitro Diagnostics > News
Magellan Diagnostics receives FDA clearance for LeadCare Plus Clinical Lead Analyzer
By MDBR Staff Writer
Magellan Diagnostics, has received US Food and Drug Administration (FDA) 510(k) clearance to market the LeadCare Plus Blood Lead Testing System in the US for the quantification of lead levels in blood.
Diagnostics > In Vitro Diagnostics > News
Illumina introduces Illumina SeqLab
By MDBR Staff Writer
Illumina announced the launch of Illumina SeqLab, an integrated solution for customers with HiSeq X Systems to enable large-scale human whole-genome sequencing operations.
Diagnostics > In Vitro Diagnostics > News
Alere to sell BBI business for $164m and acquires US Diagnostics for $60m
By MDBR Staff Writer
US-based Alere has signed an agreement with UK-based private equity firm Exponent Private Equity to divest its BBI business, for around $164m.
Diagnostics > In Vitro Diagnostics > News
QIAGEN companion diagnostic wins FDA approval for use with IRESSA
By MDBR Staff Writer
QIAGEN received US marketing (PMA) approval of its therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca's IRESSA (gefitinib) in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC).
Diagnostics > In Vitro Diagnostics > News
Luminex seeks FDA approval for Aries system and Aries HSV 1&2 assay
By MDBR Staff Writer
Luminex is seeking approval from the US Food and Drug Administration (FDA) for its Aries system and Aries HSV 1&2 assay.
Diagnostics > In Vitro Diagnostics > News
Fluidigm, OpGen enter into strategic agreement to develop multi-drug resistance testing kits and equipment
By MDBR Staff Writer
Fluidigm and OpGen announced an expanded relationship and new agreement that includes collaborating on the development of test kits and custom analytic instruments for identification, screening, and surveillance testing of multi-drug resistance organism (MDRO) genes of pathogens, such as bacteria, fungi and viruses.
Diagnostics > In Vitro Diagnostics > News
SeraCare introduces new biosynthetic reference material for NGS assays
By MDBR Staff Writer
SeraCare Life Sciences’ new precision medicine business unit has introduced its first product, Seraseq Solid Tumor Mutation Mix—I (AF20).
Diagnostics > In Vitro Diagnostics > News
Netherlands’ LabPON deploys Philips IntelliSite Pathology Solution
By MDBR Staff Writer
Netherlands-based LabPON has deployed Royal Philips’ IntelliSite Pathology Solution, transitioning completely to digital diagnosis.
Diagnostics > In Vitro Diagnostics > News
QIAGEN expands QIAsymphony test menu in partnership with Seegene
By MDBR Staff Writer
QIAGEN announced a collaboration in which Seegene will develop a menu of multiplex assay panels for its modular QIAsymphony RGQ MDx automation platform.
Diagnostics > In Vitro Diagnostics > News
Asuragen introduces new Quantidex Pan Cancer kit
By MDBR Staff Writer
Molecular diagnostics firm Asuragen has introduced new Quantidex Pan Cancer Kit, a workflow solution for targeted next-generation sequencing (NGS).
Diagnostics > In Vitro Diagnostics > News
Moleculera Labs receives grant from OCAST to develop assays
By MDBR Staff Writer
Moleculera Labs announced the receipt of a two-year, $300,000 matching grant from the Oklahoma Center for the Advancement of Science and Technology (OCAST).
Diagnostics > In Vitro Diagnostics > News
Theranos obtains FDA approval for HSV-1 test
By MDBR Staff Writer
Health technology firm Theranos has obtained approval from the US Food and Drug Administration (FDA) for its test system and test for herpes simplex 1 virus (HSV-1) IgG.
Diagnostics > In Vitro Diagnostics > News
SeraCare Life, NCI partner to develop controls for cancer assays
By MDBR Staff Writer
Vitro diagnostics manufacturer SeraCare Life Sciences will develop reference materials and positive controls for cancer assays, under a partnership with the National Cancer Institute (NCI).
Diagnostics > In Vitro Diagnostics > News
Boston IVF and IviGen partner to improve fertility outcomes
By MDBR Staff Writer
Boston IVF, a provider of in vitro fertilization services in the US, IviGen and its parent company iGenomix, worldwide providers of advanced services in reproductive genetics, have announced a partnership which will provide comprehensive genetic testing services to Boston IVF patients.
Diagnostics > In Vitro Diagnostics > News
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