This is the first companion diagnostic to detect gene fusions across all solid tumors; Caris expects to submit for Pre-Market Approval later this year Caris Life Sciences, a leading innovator in molecular...
Read More »sRNAlytics receives FDA support for an AI-powered, small RNA sequencing analysis platform
The FDA’s Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program issued a Letter of Support to sRNAlytics encouraging the...
Read More »Ignyta Announces Approval of an Investigational Device Exemption (IDE) for its RNA Sequencing based Companion Diagnostic Assay
Ignyta, Inc., a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its RNA-based companion diagnostic, next-generation sequencing (NGS) assay (Trailblaze Pharos™). The ...
Read More »FDA’s new Next Generation Sequencing Draft Guidance excludes RNA-Seq
from JDSupra Business Advisor by Gail Javitt – The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation Sequencing (NGS)-based technology. The Draft Guidance − “Use of Standards in ...
Read More »The FDA weighs in on RNA-Seq
The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemented ...
Read More »Evaluating the Stability of RNA-Seq Transcriptome Profiles in Whole Blood Over Time
Researchers at the FDA have developed methods to evaluate the stability of rat whole blood expression obtained from RNA sequencing (RNA-seq) and assess changes in whole blood transcriptome profiles in experiments replicated over time. Expression was measured in globin-depleted RNA ...
Read More »Worldwide Study Demonstrates Accuracy of RNA Sequencing Techniques
E. Aubrey Thompson, Ph.D., Mayo Clinic in Florida JACKSONVILLE, Fla. — Physicians envision a future in which genomic data from patients is heavily used to manage care — but experts have questioned the accuracy and reliability of these analyses. Now, ...
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