Tag Archives: fda

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...

The FDA’s Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program issued a Letter of Support to sRNAlytics encouraging the...

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 ...

from JDSupra Business Advisor by Gail Javitt – The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation Sequencing (NGS)-based technology.  The Draft Guidance − “Use of Standards in ...

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 ...

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 ...

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, ...