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In Vitro Diagnostics News

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1-15 of 2993 results
FDA approves Banyan Biomarkers’ diagnostic blood test for traumatic brain injury
By MDBR Staff Writer
Banyan Biomarkers has secured marketing approval from the US Food and Drug Administration (FDA) for the first in vitro diagnostic blood test for traumatic brain injury (TBI).
Diagnostics > In Vitro Diagnostics > News
Anitoa launches ultra-portable qPCR system
Anitoa Systems has introduced Maverick, an ultra-portable quantitative-polymerase-chain-reaction (qPCR) system.
Diagnostics > In Vitro Diagnostics > News
Qiagen gets Japanese approval for QuantiFERON-TB Gold Plus in vitro diagnostic test
Qiagen has secured approval from the Japan’s Ministry of Health Labor and Welfare for QuantiFERON-TB Gold Plus (QFT-Plus) as an in vitro diagnostic to detect tuberculosis (TB) infection.
Diagnostics > In Vitro Diagnostics > News
Abbott supports Angle's breast cancer liquid biopsy study
By MDBR Staff Writer
Healthcare firm Abbott will provide its PathVysion HER-2 DNA FISH probe kits for use in Angle's breast cancer liquid biopsy study.
Diagnostics > In Vitro Diagnostics > News
Siemens Healthineers gets FDA clearance for blood urea nitrogen and total C02 point-of-care testing
Siemens Healthineers announced has received 510(k) clearance from the US Food and Drug Administration for its blood urea nitrogen (BUN) and total carbon dioxide (TCO2) point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances.
Diagnostics > In Vitro Diagnostics > News
Pfizer, Foundation Medicine to develop companion diagnostics for oncology treatments
By MDBR Staff Writer
Pfizer has collaborated with Foundation Medicine for the development of companion diagnostics (CDx) for its oncology portfolio.
Diagnostics > In Vitro Diagnostics > News
GE, Roche partner to develop clinical decision support software
GE Healthcare and Roche have partnered to develop integrated digital diagnostics platform to enhance oncology and critical care treatment.
Diagnostics > In Vitro Diagnostics > News
Personal Genome Diagnostics closes $75m financing round
By MDBR Staff Writer
Personal Genome Diagnostics (PGDx) has secured $75m funding to bring regulated in vitro diagnostic (IVD) genomic tests to cancer patients globally.
Diagnostics > In Vitro Diagnostics > News
Roche introduces new sample collection device for HIV plasma viral load testing
By MDBR Staff Writer
Roche has introduced new sample collection device called cobas plasma separation card for HIV plasma viral load testing.
Diagnostics > In Vitro Diagnostics > News
Inova Diagnostics gets FDA nod for first fully automated and random access Calprotectin test
Inova Diagnostics has secured approval from the the US Food and Drug Administration (FDA) for the QUANTA Flash Calprotectin test.
Diagnostics > In Vitro Diagnostics > News
Beckman Coulter Diagnostics gets FDA clearance for automated Access AMH immunoassay for fertility patients
Beckman Coulter Diagnostics has secured FDA clearance for its automated Access AMH immunoassay for in vitro diagnostic (IVD) use in the US.
Diagnostics > In Vitro Diagnostics > News
Siemens Healthineers to buy Luxembourg’s Fast Track Diagnostics
By MDBR Staff Writer
Siemens Healthineers has agreed to acquire Luxembourg-based molecular diagnostic tests supplier Fast Track Diagnostics (FTD) for an undisclosed sum.
Diagnostics > In Vitro Diagnostics > News
Hologic gets FDA 510(k) clearance for Panther Fusion AdV/hMPV/RV assay
Hologic has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion AdV/hMPV/RV assay, a multiplexed assay that runs on the new Panther Fusion system.
Diagnostics > In Vitro Diagnostics > News
Foundation Medicine gets FDA nod for pan-tumour comprehensive genomic profiling assay
By MDBR Staff Writer
Roche’s molecular information firm Foundation Medicine has secured approval from the US Food and Drug Administration (FDA) for FoundationOne CDx comprehensive companion diagnostic assay for personalised oncology care.
Diagnostics > In Vitro Diagnostics > News
Beckman Coulter seeks to sell BNP assays directly
By MDBR Staff Writer
Beckman Coulter said that it will seek court action to allow it to directly sell a natriuretic peptide assay that is currently exclusively marketed by Quidel as a result of its recent agreement with Alere.
Diagnostics > In Vitro Diagnostics > News
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