In this case study, Frontage successfully completes the method development and validation under the Sponsor's pressing timelines, while providing high quality, and reproducible data with an ISR passing rate of over 90%.
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In this poster, we validate ultra-high sensitive SIMOA assays for the successful quantitation of neurofilament light chain (NF-L) and glial fibrillary acidic protein (GFAP).
The diagnosis and treatment of human diseases and the development of new drugs increasingly rely on our ability to determine patient genotypes using accurate and sensitive pharmacogenomic tests. Many PCR and next-generation sequencing (NGS) based assay platforms are currently available.
However, the type of DNA sequence variants, the number of targets, and the sensitivity requirements are highly diverse in different studies. Here we describe the design, performance, and regulatory considerations of several assay platforms that are accurate, high throughput, cost-effective and customizable. These platforms provide high-quality pharmacogenomic data ideally suited to meet the needs of individual studies.
What will you learn?
* State-of-the-art pharmacogenomic assay platforms currently available
* How to select the optimal platform and assay design to meet the needs of individual studies
* Performances of several commercial or customized pharmacogenomic tests
* Regulatory considerations for pharmacogenomic studies
Who may this interest?
Researchers in genetic diseases, drug metabolism, and related areas
* Drug developers performing R&D and clinical trials
* Clinicians who treat genetic disorders or provide personalized precision medicine
* Genomic service providers who provide or support pharmacogenomic testing
Speaker: Dr. Peter Zhang, SME, Frontage Laboratories (PA, USA).
Dr. Peter Zhang is a subject matter expert at Frontage Laboratories (PA, USA). He received his PhD in 2003 and spent 12 years in academia as a Professor of Functional Genomics. He has authored or co-authored over 50 peer-reviewed journal articles and book chapters. Dr Zhang has taken on various technical leadership roles in the industry in the past 5 years. He currently supports genomic services at Frontage, including all PCR- and NGS-based assay platforms.
Alzheimer's disease is a devastating neurodegenerative disease, which is the only one among the top 10 deadly diseases that have almost no treatment. FDA-approved ADUHELM® from Biogen in 2021 was the first approved Alzheimer's treatment in the past 2 decades.
Current treatment plans focus on two strategies, preventing the formation and aggregation of plague proteins called amyloids and taus, or removing such proteins. ADUHELM® adopted the later pathway. Meanwhile, from the diagnostic point-of-view, we are slightly ahead of time compared with the treatment, thanks to various new technologies. In particular, highly sensitive technology and platforms enable early diagnostics.
It has been said that the diagnosis of Alzheimer's disease enters the era of biomarkers. These two biomarkers, amyloids, and taus, defines Alzheimer's disease. In this presentation, Dr. Kai Wang, Senior Director of Biomarker Services at Frontage Laboratories, Inc, focuses on highly sensitive protein biomarker assays developed and validated at a testing laboratory and their application for the diagnosis of Alzheimer's disease.