Regulatory Affairs Professionals Society

FDA drafts guidance on using next-generation sequencing to assess gene therapy safety

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...
EurekAlert!

New review decodes transcriptomics: bulk vs. single-cell RNA sequencing

A comprehensive review article titled “Bioinformatics perspectives on transcriptomics: A comprehensive review of bulk and single-cell RNA sequencing analyses,” published in Quantitative Biology, ...
ascopubs.org

Use of next generation sequencing and quantitative mass spectrometry to determine HER2 status.

Analysis of RSPO gene expression in solid tumors. This is an ASCO Meeting Abstract from the 2016 ASCO Annual Meeting I. This abstract does not include a full text component.
ascopubs.org

Image-Guided Biopsy for Relapsed Neuroblastoma: Focus on Safety, Adequacy for Genetic Sequencing, and Correlation of Tumor Cell Percent With Quantitative Lesion MIBG Uptake

Randomized Phase II Study of 3 Months or 2 Years of Adjuvant Afatinib in Patients With Surgically Resected Stage I-III EGFR-Mutant Non–Small-Cell Lung Cancer Needle biopsy represents a less invasive ...