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In Vitro Diagnostics News

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1-15 of 2977 results
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
GNA Biosolutions reveals new ultrafast PCR platform at Medica
German molecular technology firm GNA Biosolutions has launched Pharos V8, the world's first Laser PCR platform.
Diagnostics > In Vitro Diagnostics > News
Inotrem, Roche Diagnostics partner to develop companion diagnostic test
Inotrem has signed a R&D collaboration agreement with Roche Diagnostics to develop a companion diagnostic test using a soluble plasma circulating protein (sTREM-1) developed by Inotrem and the Roche proprietary Elecsys platform.
Diagnostics > In Vitro Diagnostics > News
Roche gets FDA approval for Ventana ALK CDx assay to identify lung cancer patients eligible for treatment with Alecensa
Roche has obtained US Food and Drug Administration (FDA) approval for the Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Roche medicine ALECENSA (alectinib).
Diagnostics > In Vitro Diagnostics > News
Sysmex America gets FDA nod for complete blood cell count test
By MDBR Staff Writer
Sysmex America has secured approval from the US Food and Drug Administration (FDA) for a complete blood cell count (CBC) test.
Diagnostics > In Vitro Diagnostics > News
Natera selected for UK longitudinal breast cancer liquid biopsy study
By MDBR Staff Writer
Imperial College London and the University of Leicester have selected genetic testing company Natera for longitudinal circulating tumor DNA study in breast cancer.
Diagnostics > In Vitro Diagnostics > News
Luminex receives FDA clearance for ARIES Group A Strep assay
Luminex announced that it has received FDA clearance for the ARIES Group A Strep assay, a moderate complexity, sample to answer test for the direct detection of Streptococcus pyogenes from throat swab specimens using the ARIES® System.
Diagnostics > In Vitro Diagnostics > News
Quidel gets FDA nod for Solana RSV + hMPV assay
By MDBR Staff Writer
Diagnostic testing solutions provider Quidel has secured approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) assay.
Diagnostics > In Vitro Diagnostics > News
Roche gets FDA approval for cobas Zika test
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has approved Roche’s new qualitative nucleic acid test to detect Zika virus in blood donations.
Diagnostics > In Vitro Diagnostics > News
Alere i Influenza A & B 2 rapid molecular test gets FDA clearance
Alere announced that its i Influenza A & B 2 test has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for the detection of influenza A and B infection in children and adults.
Diagnostics > In Vitro Diagnostics > News
Mologic gets CE Mark for BVPro point-of-care diagnostic for patients with bacterial vaginosis
Mologic has received CE mark approval for BVPro, a rapid point-of-care test for patients presenting with symptoms of vaginosis.
Diagnostics > In Vitro Diagnostics > News
Patterson Dental, Align Technology sign distribution deal for intraoral scanning system
Patterson Dental, a business unit of Patterson Companies, and Align Technology have signed a distribution agreement for Align’s iTero Element intraoral scanning system.
Diagnostics > In Vitro Diagnostics > News
Quanterix to launch assays for multiplex biomarker detection
Quanterix announced that it will be expanding its single molecule array or Simoa technology platform portfolio to include the new Quanterix SR-Plex benchtop instrument.
Diagnostics > In Vitro Diagnostics > News
1-15 of 2977 results