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更新于：2025-09-25
Roche Diagnostics GmbH
更新于：2025-09-25
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CTR20251827
一项在中国复发型多发性硬化和原发进展型多发性硬化患者中评价OCRELIZUMAB的有效性、安全性、药代动力学和药效学的多中心、开放性、单臂研究
NL-OMON57218
Technical validation of transport and temperature stability at room temperature of presepsin measured with Elecsys presepsin - Presepsin pilot study
NCT06849752
EAGLE-HF is Part of a Multinational Group of Studies Titled; Screening for Early Heart Failure Diagnosis and Management in Primary Care or at Home Using Natriuretic Peptides and Echocardiography
100 项与 Roche Diagnostics GmbH 相关的临床结果
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2025-12-01New Biotechnology
Viability assessment and biomass valorization of recombinant Komagataella phaffii
Article
作者: Baumgartner, Tobias ; Herrmann, Christiane ; Gangl, Sarah ; Spielhaupter, Christian ; Schneider, Frank ; Geier, Martina ; Hilgarth, Maik ; Glieder, Anton ; Recher, Christina ; Wassermann, Birgit
Komagataella phaffii has become a key player in biotechnology used for the production of heterologous proteins with numerous GRAS notices and QPS status released in the past years. While most of these descriptions and scientific studies focus on strain engineering, products and cultivation processes, this paper provides fundamental data about the general viability of K. phaffii after post-production biomass treatments and co-incubations with non-sterile soil and water samples. A comparison of different K. phaffii strains uncovered a high thermal sensitivity for all tested strains, which was further enhanced under alkaline conditions. A rapid reduction in the viable cell number started at approx. 52 °C and terminated in a full loss of 109 viable cells per milliliter within seconds at 70 °C. Survival rates of untreated non-GMO and GMO K. phaffii strains in water- and soil-slurry-microcosms demonstrated that the number of viable K. phaffii cells decreased rapidly and comparably to a Saccharomyces cerevisiae reference. No mating events were detected under these environmental conditions. These findings supported assumptions that K. phaffii is highly specialized and not a ubiquitous microorganism as described for other yeasts. Finally, intrigued by the low survival outside optimal laboratory conditions, K. phaffii biomass was evaluated in mesophilic anaerobic digestion processes for energy production. Enhanced methane yields and a concomitant loss of viable K. phaffii cells were demonstrated.
2025-10-01Neurology and Therapy
Clinical Performance of the Elecsys CSF pTau181/Aβ42 Ratio for Concordance with Tau-PET in Two Independent Cohorts
Article
作者: Shaw, Leslie ; Burnham, Samantha C ; Andreadou, Myrto ; Palmqvist, Sebastian ; Mattsson-Carlgren, Niklas ; Klein, Gregory ; Smith, Ruben ; Tonietto, Matteo ; Quijano-Rubio, Clara ; Stomrud, Erik ; Rank, Christopher M
INTRODUCTION:
Amyloid- and tau-positron emission tomography (PET) are promising modalities for detecting pathological changes associated with Alzheimer's disease (AD); however, their application is limited. Although the use of cerebrospinal fluid (CSF) biomarkers as alternatives to amyloid-PET and tau-PET has been explored, no in vitro diagnostic-approved or commercial CSF biomarker assays are currently available for detecting tau pathology in clinical practice.
METHODS:
In this study, we determined and validated the optimal cutoff value for the ratio of tau phosphorylated at a threonine residue at position 181 (pTau181) to β-amyloid(1-42) (Aβ42) in CSF, measured with the Elecsys® Phospho-Tau (181P) CSF and β-Amyloid(1-42) CSF immunoassays (Roche Diagnostics International Ltd, Rotkreuz, Switzerland), based on its concordance with binary tau-PET status. Clinical performance was explored using CSF measurements and tau-PET scans retrospectively obtained from a subset of subjects with mild cognitive impairment and dementia due to AD in two independent cohorts, Alzheimer's Disease Neuroimaging Initiative-2/3 (ADNI-2/3; N = 133) and Swedish BioFINDER-2 (N = 62).
RESULTS:
In the first part of this analysis (ADNI-2/3 pre-analytics), a CSF pTau181/Aβ42 cutoff value of 0.0395 was selected as the best compromise between positive percent agreement (PPA) and negative percent agreement (NPA) for the tau-PET visual read endpoint. After adjustment to account for differences between the ADNI-specific protocol and the manufacturer's recommended pre-analytical protocol used in BioFINDER-2, the optimal CSF pTau181/Aβ42 cutoff value was set at 0.037. The adjusted cutoff was validated in BioFINDER-2 and was associated with a PPA of 85.7% (95% confidence interval [CI] 70.6, 93.7), NPA of 70.4% (95% CI 51.5, 84.1), and overall percent agreement (OPA) of 79.0% (95% CI 67.4, 87.3); the positive and negative likelihood ratios were 2.89 and 0.203, respectively.
CONCLUSION:
The Elecsys CSF pTau181/Aβ42 ratio may be a reliable tool for identifying tau pathology in clinical practice.
2025-09-01Journal of diabetes science and technology
Efficacy of a Digital Diabetes Logbook for People With Type 1, Type 2, and Gestational Diabetes: Results From a Multicenter, Open-Label, Parallel-Group, Randomized Controlled Trial
Article
作者: Roos, Timm ; Schäfer, Vanessa ; Krichbaum, Michael ; Haak, Thomas ; Ziegler, Ralph ; Finke-Gröne, Katharina ; Kober, Johanna ; Hermanns, Norbert ; Rieger, Cosima ; Bingol, Ezgi ; Silbermann, Stephan ; Heinemann, Lutz ; Ehrmann, Dominic ; Kulzer, Bernhard
Background::
In a randomized controlled trial, the efficacy of a digital diabetes diary regarding a reduction of diabetes distress was evaluated.
Methods::
A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923).
Results::
Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: −2.50 to 8.11) in the intervention group and 1.25 (IQR: −5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (−2.20, IQR: −4.02 to −0.38,
P
= .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group.
Conclusions::
The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.
2025-08-18
申请上市临床申请
2025-08-13
引进/卖出申请上市临床申请临床1期
2025-07-09
诊断试剂上市批准免疫疗法临床研究
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