Oxford Nanopore and Lonza Team Up, Medidata and Sanofi Vaccines Collaborate, More

By Bio-IT World Team  

February 29, 2024 | Oxford Nanopore and Lonza have teamed up to cGMP validate and commercialize a first-of-its-kind novel test to accurately determine multiple critical quality attributes of mRNA products by directly sequencing both the DNA template and the messenger RNA; Parse updates whole transcriptome kit; and more. 

Lonza announced a collaboration with Oxford Nanopore. The collaboration aims to cGMP validate and commercialize a first-of-its-kind novel test to accurately determine multiple critical quality attributes of mRNA products by directly sequencing both the DNA template and the messenger RNA (mRNA). As part of the collaboration, Oxford Nanopore will tech transfer workflows developed in house to Lonza for GMP validation, using its GridION device to generate real-time data and reporting. Following successful validation, Lonza intends to include the sequencing technology in its analytical development workflow offering, and support Oxford Nanopore in achieving stringent quality requirements for QC compliance. Press release. 

Medidata and Sanofi Vaccines announced a collaboration to harness Medidata eCOA to deploy in vaccine studies. This builds on Medidata and Sanofi’s longstanding, successful experience using Medidata Rave EDC (electronic data capture). The collaboration will use an eDiary function within eCOA to create an eDiary library specific to Sanofi’s vaccines. This library will accelerate future study set-up times, improve efficiency, and increase data quality, while ensuring patients have access to eDiaries that are easy to use. Press release.   

Parse Biosciences announced a significant update to the company’s flagship Evercode Whole Transcriptome products. Available to ship in mid-March, Evercode Whole Transcriptome version 3 kits offer researchers a more streamlined workflow, more flexible and higher throughput fixation, and optimized reagents for improved sensitivity in gene detection. Press release. The company also has entered into an agreement with INTEGRA Biosciences to integrate the Assist Plus with built-in Parse Evercode single cell protocols. Combining the scale of the Parse technology with the semi-automated liquid handling of the Assist Plus will significantly reduce hands-on time while further increasing throughput and efficiency of the workflow. As part of the agreement, Parse will sell a bundled solution composed of Evercode single cell reagents and an application-enabled INTEGRA Assist Plus instrument directly to customers. Press release. 

X-trodes announced that the U.S. Food and Drug Administration has granted 510(k) clearance for X-trodes' Smart Skin solution (marketed as X-trodes System M), a new wireless wearable technology for advanced electrophysiological monitoring. X-trodes' Smart Skin is comprised of customizable dry-printed multi-modal electrode patches. It monitors a wide range of biopotential signals from anywhere on the body to acquire EEG (brain activity), EKG/ECG (cardiac monitoring), EOG (eye movement), and EMG (muscle activity) data. The discreet patches are easy to apply and comfortable to wear, conforming to the body without requiring gels, wires, or uncomfortable solutions. Press release. 

Neogap Therapeutics has been granted a patent in Australia that covers a tolerogenic treatment method for multiple sclerosis (MS). The method uses specially designed molecules to influence the immune system's response, conditioning it to tolerate the body's cells instead of mistakenly attacking them. Correcting the immune system's misguided reactions is crucial in treating MS. The patent is valid until 2038. Beyond its application in MS treatment, the patent also incorporates methods for diagnosing MS, thus improving the prospects for early detection and treatment of the disease. Press release. 

Wasatch Biolabs launched a proprietary Targeted DNA Methylation Sequencing Service for researchers and clinical service providers. The technique is amplification and bisulfite conversion free, effectively bypassing the most common limitations of targeted methylation analysis and enabling WBL to create custom methylation panels that target an unprecedented hundreds-to-thousands of genomic loci of interest with an enrichment of 400-2300x. Press release. 

Biofourmis has entered four new agreements with top pharmaceutical companies, driven by Biofourmis' proven leadership and expertise in digital biomarker development and the strength of its comprehensive, device- and location-agnostic clinical trial solution. The new engagements focus on oncology therapies, further expanding Biofourmis' already diverse therapeutic portfolio that includes cardiovascular, pain, women's health, and immunology. Centered on developing digital biomarkers and safety monitoring algorithms, with a specific focus on cytokine release syndrome (CRS) detection, the oncology programs leverage cutting-edge data science and technology to enhance remote data collection, patient monitoring, and safety. Press release. 

DNAnexus and LORENZ Life Sciences Group have partnered to offer Trusted Regulatory Spaces—secure, cloud-native environments that improve the submission validation process and ease of sponsor-reviewer communication for human drug and biologics applications to health authorities. The engagement is highlighted by Project PRISM, a research collaboration between Industry and the U.S. Food and Drug Administration (FDA) to demonstrate the feasibility of collaborative regulatory submission validation and scientific review utilizing LORENZ’s eValidator solution deployed on precisionFDA, FDA’s production cloud platform built and powered by DNAnexus for multi-omics and real-world data regulatory science and review. The joint offering leverages in-production solutions that already meet the most stringent security, privacy, and data residency requirements and have been adopted by many leading global health authorities and life sciences organizations. Press release. 

Owkin announced it is working with Amazon Web Services (AWS) to transform drug discovery, de-risk and accelerate clinical trials, and develop AI diagnostics. Owkin will leverage AWS’s proven global infrastructure and secure, extensive, and reliable cloud platform to enhance data operations, optimize for operational excellence, and drive forward research in precision medicine. Press release. 

The Innovation and Value Initiative (IVI), in partnership with the EveryLife Foundation for Rare Diseases, released a report, “Valuing Rare Disease Treatments in Healthcare: Real Experience, Real Impact,” as part of IVI’s Rare Disease Initiative. This effort was made possible through funding support from the Eugene Washington PCORI Engagement Awards Program, an initiative of the Patient-Centered Outcomes Research Institute (PCORI), and Alexion, AstraZeneca Rare Disease. This project explored common patient-centered outcomes across rare diseases, identified evidence gaps, and built consensus on addressing unique research challenges. Press release. 

Verisense Health has adopted Datavant’s data connectivity platform to facilitate linking its Digital Health Panel to other real-world data (RWD) sources and further progress objective, digital health research. By connecting the Digital Health Panel with other sources of RWD in the Datavant Ecosystem, researchers can generate a comprehensive view of patients and insights, leading to better decision-making and health outcomes. Press release. 

Twist Bioscience launched the cfDNA Library Preparation Kit to enable liquid biopsy research. Liquid biopsy tests are designed to accurately identify tumor variants within circulating tumor DNA (ctDNA), which are often difficult to detect due to degraded or limited DNA presence. The Twist cfDNA Library Preparation Kit was purpose-built to maximize the number of unique cfDNA molecules that are captured in library preparation, for higher confidence in the accuracy and sensitivity of liquid biopsy tests. Press release. 

QIAGEN Digital Insights (QDI) announced their enhanced QIAGEN CLC Genomics Workbench Premium with LightSpeed technology now supports next-generation sequencing (NGS) for somatic cancer secondary analysis. The software accelerator converts raw sequencing data in FASTQ files to interpretable lists of genetic variants in VCF files at unprecedented low cost and high speed. Press release. 

Vector Laboratories and Navinci Diagnostics have signed an agreement. This collaboration aims to develop cutting-edge biomarker discovery tools, allowing detection of specific protein glycosylation in tissue samples for the first time. Product launches are scheduled for 2025. The collaboration between Vector Laboratories and Navinci Diagnostics will empower researchers’ ability to understand the glycosylation state of specific protein targets in the spatial context of tissue. This new innovative approach simplifies the detection of this challenging post-translational modification. Press release. 

GSK (GlaxoSmithKline) has officially chosen Preservica as its Digital Preservation and archiving supplier for their Corporate Heritage Archives. The choice of Digital Preservation reflects a strategic decision to ensure the accessibility, integrity, and longevity of these records. By leveraging Preservica, GSK not only fulfills its archival needs but also establishes a foundation to inform and protect the future of the business, offering valuable insights for strategic decision-making and ensuring a robust framework for regulatory compliance and brand continuity. Press release.