Burger line Burger line Burger line
Logo Logo Logo
Burger line Burger line Burger line
Sign in
Sign in

FDA accepts review for ANGLE’s Parsortix system for metastatic breast cancer

Liquid biopsy company ANGLE has announced that the US Food and Drug Administration has accepted its submission for substantive review of its Parsortix system for use with metastatic breast cancer (MBC) patients.

On 28 September, ANGLE said that it had submitted a full Class II De Novo FDA submission for its Parsortix PC1 system seeking FDA approval for use with MBC patients.

Following that submission, the FDA has completed its administrative review – a formal process undertaken by the FDA to determine that the submission contains all the necessary elements and information needed for the FDA to proceed with a substantive review.

ANGLE’s Parsortix system uses cell separation technology and enables a liquid biopsy to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses.

The system can capture all types of circulating tumour cells (CTC) as well as CTC clusters in a viable form. CTCs allow a comprehensive picture of a cancer to be seen as they allow DNA, RNA and protein analysis and thus provide comparable analysis to a tissue biopsy.

In addition, CTC analysis is a non-invasive process so it can be repeated as often as needed – an important factor since cancer develops and changes over time.

“We are pleased that our FDA submission has successfully completed FDA administrative review and is now in substantive review,” said Andrew Newland, founder and chief executive of ANGLE.

“We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer.”

20th October 2020


0
Cart Subtotal:
Go to cart
You will be able to Pay Online or Request a Quote

We use "cookies*  to ensure the functionality of our website, recognise your browser or device, learn more about your interests, and provide you with essential features and services and for additional purposes, including:

Recognising you when you sign-in to use our services. This allows us to provide you with product recommendations, display personalised content, and provide other customised features and services.
Keeping track of your specified preferences. You may set your preferences through Your Account..
Keeping track of items stored in your shopping basket and personal cabinet.
Conducting research and diagnostics to improve ChemDiv’s content, products, and services.
Delivering content, including ads, relevant to your interests on ChemDiv’s site
Reporting. This allows us to measure and analyse the performance of our services.

By  cookies you give consent to the processing of your personal data, including transfer to third parties. Further information can be found in our privacy policy.

Accept all cookies