31 Clinical, Medical & Diagnostic Products
allows for early discussions on corrective actions before issues escalate into non- conformities or the need for corrective and preventive actions (CAPAs). By addressing potential risks constructively, manufacturers and suppliers can collaborate to identify and resolve problems in the supply chain, thereby reducing the chances of costly compliance failures or disruptions.
Ultimately, whether through an internal audit or gap analysis, taking a proactive approach to supplier oversight empowers manufacturers to address risks before they escalate into compliance issues. By investing in regulatory expertise and obtaining objective feedback on potential gaps in the supply chain, businesses can avoid costly disruptions, maintain operational effi ciency, and stay ahead of regulators
A strategic approach to mitigating supply chain
risks in medical device manufacturing A strategic approach to mitigating global supply chain risks in medical device manufacturing involves a comprehensive focus on the early identifi cation of potential
New assay kit simplifi es mitochondrial function analysis
Agilent Technologies has introduced the Mito-rOCR Assay Kit, a streamlined solution that simplifies the analysis of mitochondrial function for researchers of all skill levels. This cost-effective kit enables functional assessment of mitochondrial respiration in cell physiology and disease pathology studies, making advanced mitochondrial research more accessible.
Mitochondria play a crucial role in energy production, and mitochondrial dysfunction is linked to various diseases. The Mito-rOCR Assay Kit provides an easy and reliable way to measure relative oxygen consumption rate (rOCR), offering insights into mitochondrial health. Researchers can use the assay with a range of compatible fluorescence plate readers and multimode imagers that meet sensitivity, detection, and environmental control requirements.
The BioTek Cytation series, ideal for use with the Mito-rOCR assay, supports automated processes and ensures optimal conditions for diverse research needs. The assay measures rOCR, enabling sensitive detection of changes in mitochondrial function without interfering with cellular processes. The reagent remains outside the cells, ensuring it can be easily removed for further downstream analysis.
Data analysis is simplified using the Mito-rOCR Analysis Module within Agilent Seahorse Analytics, a cloud-based software that makes data import, linearisation, and chart creation easy and efficient.
Chris Braun, Associate Vice President of Marketing in Agilent’s Cell Analysis Division, commented: “The Mito-rOCR Assay Kit was developed in response to customer feedback, providing an easy-to- use assay that works with various fluorescence plate readers. This kit empowers more researchers to study cellular respiration and mitochondrial function.”
The Mito-rOCR Assay Kit is part of Agilent’s expanding suite of metabolic analysis tools, offering researchers a comprehensive view of cellular metabolism and supporting advancements in biological research.
More information online:
ilmt.co/PL/MbD6 63622pr@reply-direct.com 510(k) clearance granted for COVID-19 diagnostic PCR kit
Thermo Fisher Scientific has announced that its Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit has received 510(k) clearance from the US Food & Drug Administration (FDA). Initially introduced as an Emergency Use Authorized (EUA) test, the 510(k) clearance now allows clinical and public health laboratories to transition to an in vitro diagnostic (IVD) workflow. This marks a significant step in supporting the ongoing response to the COVID-19 pandemic.
Thermo Fisher Scientific remains committed to driving continuous innovation for its clinical customers. The 510(k)-cleared TaqPath COVID-19 Diagnostic PCR Kit is built upon the same chemistry as the EUA kit, which was used to test over one billion patient samples during the height of the COVID-19 pandemic. The kit is intended for use with nasopharyngeal and anterior nasal swab samples, and it includes all necessary assays and controls for real- time PCR detection of RNA from the SARS-CoV-2 virus. The multi-gene target design of the TaqPath COVID-19 Diagnostic PCR Kit, which includes the ORF1ab, N gene, and S gene, provides greater confidence in results and supports an accurate diagnosis as new mutations of the virus continue to emerge.
The TaqPath COVID-19 Diagnostic PCR Kit is designed for use in a range of settings, including reference and clinical laboratories, public health laboratories, and academic medical centres. With a proven track record of performance and reliability, the kit is validated for use on common PCR instruments in the United States. Building on the foundation of the emergency-use-authorised COVID-19 test, the 510(k)-cleared version ensures consistent performance and is ready for widespread use. Results can be delivered in as little as three hours, enabling care teams to make rapid, informed decisions and determine the best course of treatment for patients. Thermo Fisher’s continuous commitment to improving diagnostic solutions helps laboratories maintain high standards of accuracy and reliability in the ongoing battle against COVID-19.
More information online:
ilmt.co/PL/mn5w 63718pr@reply-direct.com Clinical-grade long-read sequencing test gains US regulatory approval
Azenta, Inc has introduced a long-read Whole Genome Sequencing (WGS) test for clinical applications, becoming the first commercial provider to secure regulatory approval for this offering in the United States.
Unlike traditional short-read sequencing methods, which often struggle to identify genetic variants in repetitive regions of the genome linked to rare diseases, Azenta’s test uses PacBio’s Revio sequencer to generate long and highly accurate HiFi sequencing reads. This approach enables comprehensive coverage of genomic regions that short-read technologies fail to access. Conducted within GENEWIZ from Azenta Life Sciences’ CLIA-certified and CAP-accredited clinical genomics laboratory, the test allows for precise detection of complex genomic alterations that are often missed by conventional sequencing methods, providing an unprecedented level of genomic insight.
Dr Ginger Zhou, Senior Vice President & General Manager of GENEWIZ Multiomics and Synthesis Solutions at Azenta Life Sciences, emphasised the significance of this advancement: “Clinical-grade long-read sequencing marks a major step forward in understanding the genetic basis of rare diseases. By capturing extensive DNA sequences in a single read, researchers can detect subtle genetic variations that were previously undetectable with conventional methods. This breakthrough enhances diagnostic accuracy while also paving the way for more targeted therapies and improved clinical trials.”
Christian Henry, President and Chief Executive Officer of PacBio, highlighted the role of PacBio’s technology in advancing genomic research: “Azenta’s test demonstrates the power of our Revio sequencer in generating the most precise and comprehensive genomic data available today. The accuracy of HiFi reads is transforming rare disease research, allowing scientists to uncover intricate genetic details. We are proud to support Azenta in pushing the boundaries of clinical genomics with these deeper, more precise insights.”
More information online:
ilmt.co/PL/1y18 63791pr@reply-direct.com
risks and regulatory challenges. By proactively addressing these factors, companies can not only maintain compliance but also ensure product quality and safety while minimising operational disruptions. Effective management of supplier audits and controls is essential to staying ahead of evolving global regulatory landscapes. This proactive approach helps manufacturers avoid costly recalls, penalties, and reputational damage, ultimately enhancing competitiveness. Furthermore, it strengthens long-term business resilience, allowing companies to adapt and succeed in an increasingly complex and demanding regulatory environment.
About the author:
Dr Oliver Eikenberg is the Global QA/RA & IVDR Manager at Pure Global and brings over 14 years of experience in the medical device industry and 15 years in regulatory consulting, specialising in EU, US, and Australian regulations. He has deep expertise in IVD genetic tests, Companion Diagnostics, clinical performance studies, and regulatory interactions.
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