News & Events

News & Events2022-04-29T14:41:55+00:00
502, 2021

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic

February 5th, 2021|COVID-19, FDA Guidance|

The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and [...]

1610, 2020

MASS General researchers show ddPCR brain tumor liquid biopsy assay has tenfold improvement in sensitivity over any prior assay

October 16th, 2020|Digital PCR|

Genetic mutations that promote the growth of the most common type of adult brain tumors can be accurately detected and monitored in blood samples using an enhanced form of liquid biopsy developed by researchers at Harvard-affiliated Massachusetts General Hospital (MGH). [...]

1208, 2020

FDA approves first liquid biopsy next-generation sequencing companion diagnostic test

August 12th, 2020|FDA Sequening|

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a [...]

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