Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Hopes ClinGen Database Will Spur Next-Gen Sequencing Products

Executive Summary

The agency says it has evaluated ClinGen and will accept evidence based on the US National Institutes of Health-funded database for product applications. It hopes the use of the database will spur development of targeted treatments and diagnostics such as next generation sequencing tests.

You may also be interested in...



FDA-Backed Tumor Mutation Database Gives Diagnostics Developers Another Premarket Submission Tool

The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.

First Test That Can Detect COVID-19 Virus Mutations Authorized By FDA

The US FDA on 10 June authorized use of Illumina’s COVIDSeq next generation sequencing diagnostic test to detect the SARS-CoV-2 virus and figure out if it’s mutating. The agency has high hopes this first-of-its-kind test will give researchers a better picture in the ongoing global fight against the COVID-19 pandemic.

FDA Finalizes Guidelines To Promote Next-Gen Sequencing Technology

The promise of next-generation sequencing technology to help patients understand risk and target treatment for disease is high. US FDA is hoping to help accelerate practical advancements with the release of two final guidances addressing NGS technology and databases that aggregate genomic information.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT124328

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel