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In Vitro Diagnostics News

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BIT Group introduces new IVD white label instruments
By MDBR Staff Writer
IVD instrument developer and manufacturer BIT Group has introduced new product line of customizable IVD white label instruments.
Diagnostics > In Vitro Diagnostics > News
UK’s MRC and EPSRC support six universities to develop new molecular pathology tests
By MDBR Staff Writer
The Medical Research Council (MRC) and Engineering and Physical Sciences Research Council (EPSRC) have jointly awarded £16m fund to six universities in the UK to develop new molecular pathology tests.
Diagnostics > In Vitro Diagnostics > News
MeMed receives European Commission’s fund to advance its ImmunoDx project
By MDBR Staff Writer
The European Commission (EC) has provided a €3m fund for MeMed to advance its ImmunoDx project.
Diagnostics > In Vitro Diagnostics > News
True Diagnostics obtains Chinese approval for Jianjie TSH test and Bochi Reader
By MDBR Staff Writer
Global point-of-care firm True Diagnostics has obtained approval from the China CFDA for its Jianjie TSH test and Bochi Reader.
Diagnostics > In Vitro Diagnostics > News
Roche Diagnostics introduces new Elecsys HTLV-I/II immunoassay
By MDBR Staff Writer
Switzerland-based Roche has introduced new Elecsys HTLV-I/II immunoassay, a diagnostic test developed to detect antibodies against Human T-lymphotropic virus I or II infection (HTLV-I/II) in donated blood and routine diagnostic samples.
Diagnostics > In Vitro Diagnostics > News
FDA grants approval for Inova Diagnostics’ Quanta Flash assays
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has granted 510(k) approval for Inova Diagnostics’ Quanta Flash connective tissue disease assays.
Diagnostics > In Vitro Diagnostics > News
UK's Cytox, Affymetrix to develop new blood-based genetic assay
By MDBR Staff Writer
UK-based Cytox has partnered with Affymetrix to develop and commercialize blood-based genetic assay for risk assessment of Alzheimer’s disease (AD).
Diagnostics > In Vitro Diagnostics > News
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
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