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Tag Archives: Roche Diagnostics—

Elecsys CSF assays get breakthrough approval

July 25, 2018—The Food and Drug Administration granted breakthrough device designation to Roche’s Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-amyloid (1-42) and phospho-tau concentrations in cerebrospinal fluid in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia. Measuring ...

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Roche launches digital pathology slide scanner

March 28, 2018—Roche launched the Ventana DP 200 high-speed slide scanner for digital pathology. The scanner features a tray-based design that enables no-touch slide processing for reduced workflow and a scan speed of less than 49 seconds for a 15-by-15 millimeter scan area. It is Digital Imaging and Communications in Medicine (DICOM) standard compatible and integrates with image management servers, ...

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Horizon, Roche team up to develop IHC assays

Dec. 20, 2017—Horizon Discovery Group announced that it has entered into an agreement with Roche Diagnostics to assist in the development of immunohistochemistry assays. Under the terms of the agreement, Horizon will develop and provide reference standard material expressing neurotrophic tropomyosin receptor kinase fusion biomarkers. NTRK gene rearrangements have emerged recently as promising targets for cancer therapy, and a number ...

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FDA approves Ventana ALK (D5F3) CDx Assay

Nov. 9, 2017—Roche has obtained FDA approval for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with the Roche medicine Alecensa (alectinib). It is the only test FDA approved as a companion diagnostic for Alecensa, the company says. “We are very excited about the companion diagnostic label ...

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Roche offers tumor board software solution

Oct. 18, 2017—Roche launched the Navify Tumor Board solution, a clinical workflow and decision support software that optimizes decision-making for cancer patient case reviews in tumor boards or multidisciplinary team meetings. The solution aims to fundamentally change the way these meetings are organized and conducted. The Navify Tumor Board solution collects relevant patient data from patients’ medical history, biomarkers, tumor ...

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FDA OKs test for screening Zika in donated blood

Oct. 10, 2017—The U.S. Food and Drug Administration approved on Oct. 5 Roche’s Cobas Zika test for use on the company’s fully automated Cobas 6800/8800 systems. The test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from volunteer donors of whole blood and blood components and from living ...

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CE mark for Roche’s Harmony NIPT

Oct. 3, 2016—Roche announced that its Harmony Prenatal Test for assessing the probability of Down syndrome and other chromosomal disorders has received the CE mark. Initially introduced in 2012 as a send-out test designed to assess the probability of fetal trisomy 21, 18, 13, and sex chromosome aneuploidy, the second-generation Harmony Prenatal Test has improved performance while reducing costs and ...

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FDA OKs Roche Zika test for emergency use

Sept. 13, 2016—The Food and Drug Administration has issued an emergency use authorization for Roche‘s LightMix Zika rRT-PCR Test. The product is for use in patients meeting CDC Zika virus clinical criteria or CDC Zika virus epidemiological criteria. The test is used for the detection of Zika virus in EDTA plasma or serum samples using Roche’s LightCycler 480 Instrument II ...

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Roche’s test for flu A/B and RSV waived

Aug. 16, 2016—Roche announced that the Food and Drug Administration has granted 510(k) clearance and a CLIA waiver for the Cobas Influenza A/B and RSV test for use on the Cobas Liat system. “For young children and the elderly, it is essential to have a differential diagnosis for RSV and flu to ensure appropriate treatment within a short time frame ...

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