隶属于 DANAHER CORP.
相关临床试验
15
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1996
已完成
9
60.0%
Enrolling By Invitation
1
6.7%
尚未招募
3
20.0%
Unknown
2
13.3%
暂无批准数据
- A randomized trial of 276 women found that point-of-care NAAT (Xpert Xpress MVP) raised appropriate treatment within 24 hours to 83.2%, versus 51.3% with usual care (P < 0.001). - Among women with no detectable vaginal pathogens, unnecessary antimicrobial treatment fell from 50.0% in usual care to 27.1% in the POC NAAT arm (P = 0.031). - Wet mount microscopy showed limited sensitivity (50% for Candida and TV, 63% for BV), while 87% of providers said they would adopt POC NAAT in routine practice. - The study, led by Magee-Womens Research Institute and the University of Pittsburgh, is the first randomized trial evaluating a multiplex molecular test for vaginitis at the point of care.
- Nanopore sequencing delivers long reads, real-time data streaming, and portability, reducing turnaround times to as little as four hours compared with 24–72 hours for short-read platforms. - The technology enables high-resolution HLA typing for transplantation, rapid pathogen and antimicrobial resistance detection, pharmacogenomics, and oncology applications including liquid biopsy and intraoperative diagnostics. - Recent chemistry and base-calling advances have raised median read accuracy to Q32 (99.93%), while adaptive sampling allows PCR-free, on-device target enrichment in 4–24 hours. - Standardization, version control, computational demands, and reference-data gaps remain key barriers to broad clinical deployment of nanopore-based workflows.
- The Fleming Initiative and Cepheid have launched TRACE-CPE, a 30-month real-world study at two major London NHS Trusts to evaluate rapid molecular screening for carbapenemase-producing Enterobacterales (CPE). - The study compares rapid molecular diagnostics delivering results in approximately one hour against current culture-based screening that typically takes around 48 hours. - CPE is classified by the WHO as a critical-priority pathogen, and UKHSA data show acquired carbapenemase-producing organisms in England more than doubled between 2021 and 2023. - Findings aim to provide policymakers and clinicians with evidence on how rapid CPE screening should be deployed across the NHS and comparable health systems facing drug-resistant infections.
- Danaher will acquire pulse oximeter maker Masimo for $9.9 billion at $180 per share, representing a 38.3% premium to expand its diagnostics portfolio into patient monitoring technologies. - The acquisition allows Danaher to complement its invasive Radiometer blood analyzer devices with Masimo's non-invasive pulse oximeters and gain a foothold in the growing patient-monitoring device market. - Masimo is expected to add $0.15 to $0.20 to Danaher's adjusted diluted net earnings per share in the first full year and about $0.70 in the fifth full year following completion. - The deal represents Danaher's largest acquisition since its $5.7 billion purchase of Abcam in 2023 and is expected to close by the second half of 2026.
- Cepheid has received Health Canada medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation molecular test for monitoring HIV viral load levels. - The dual target test provides extended strain coverage with a 90-minute turnaround time to improve patient access to standard care. - The test is designed for use on Cepheid's GeneXpert® Systems across various healthcare settings from hospitals to community clinics. - Xpert® HIV-1 Viral Load XC will begin shipping to Canadian customers in June 2025 to support UNAIDS HIV targets by 2030.
• Cepheid and Oxford Nanopore Technologies have formed a strategic partnership to develop an integrated workflow combining Cepheid's GeneXpert system with Oxford Nanopore's sequencing platform for infectious disease analysis. • The collaboration will initially focus on bacterial and fungal pathogen profiling through whole genome sequencing, with plans to expand into cancer, human genetics, and eventually clinical diagnostics. • The joint solution aims to deliver sequencing results within hours instead of days, making advanced genomic analysis accessible to laboratories without specialized sequencing expertise.
• A new, high-sensitivity HER2 assay developed by Dr. Rimm's lab aims to improve the accuracy and sensitivity of HER2 testing, crucial for identifying patients who may benefit from ADCs. • The assay utilizes immunofluorescence to measure HER2 antibody binding, offering a more quantitative approach compared to traditional methods, potentially increasing sensitivity by tenfold. • Danaher's Beacons program supports the assay's development into a standardized product through collaboration with Leica Biosystems and a clinical trial in partnership with Cepheid. • The clinical trial will assess both the new HER2 assay and Cepheid's STRAT4 assay, which measures HER2 RNA levels, to determine the optimal method for predicting ADC response in breast cancer patients.
• A new point-of-care hepatitis C virus (HCV) RNA assay (Xpert HCV) has shown potential for rapid diagnosis in non-traditional settings, particularly for individuals under community supervision. • The FDA granted marketing authorization for the Xpert HCV test in June 2024, streamlining the HCV testing process and enabling quicker treatment initiation. • Study results demonstrated high sensitivity (96.8%) and specificity (99.4%) of the Xpert HCV test for detecting HCV RNA, confirming its feasibility and accuracy. • The availability of point-of-care testing could allow for same-day initiation of curative HCV treatment, especially benefiting marginalized populations with limited access to care.
