Angle PLC - Successful face-to-face meeting with FDA
For immediate release
22 January 2020
SUCCESSFUL FACE-TO-FACE MEETING WITH FDA TO REVIEW PARSORTIX Q-SUBMISSION
Full De Novo FDA Submission expected in Q1 CY20
Prospect of FDA clearance in Q3 CY20
After completion of clinical and analytical studies demonstrating the performance of the Parsortix system for harvesting circulating tumour cells in metastatic breast cancer, ANGLE made a substantial Q-Submission (a "pre-submission" used to request formal comment from FDA on key questions) to FDA on
FDA provided a formal written response to ANGLE's Q-Submission in advance of the formal face-to-face meeting with ANGLE held last week to discuss this response. Following the success of this meeting, ANGLE is now able to prepare a full De Novo FDA Submission to FDA requesting clearance of the Parsortix system for use in metastatic breast cancer. While some additional analytical study work was requested by FDA, this will be undertaken in parallel with the submission drafting and have no impact on the overall timescales and incur de-minimis additional cost.
Whilst significant work remains to complete the written submission, which is expected to run to several thousand pages, all of which will be subject to substantive review and questioning by FDA, ANGLE believes that all of the critical issues were addressed in the meeting and that there is now a clear route to full De Novo FDA Submission.
ANGLE is progressing the full De Novo FDA Submission as quickly as possible with the aim of making a submission in Q1 CY20 with the prospect of FDA clearance in Q3 CY20 (unchanged). The outcome and timing of any FDA regulatory decision is entirely dependent on
ANGLE Founder and Chief Executive,
"We are delighted with the ongoing positive discussions with FDA and that there is a clear route for the full De Novo FDA Submission. 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. We believe that FDA regulatory clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate our Parsortix liquid biopsy system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings."
For further information ANGLE:
| || |
+44 (0) 1483 343434
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance -
+44 (0)20 7220 0500
+44 (0) 203 705 9330
+44 (0) 203 727 1000
+1 (212) 850 5624
The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.
For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/
Notes for editors
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). CTCs enable the complete picture of a cancer to be seen as being a complete cell they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. The Parsortix technology is the subject of 24 granted patents in
ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 26 peer-reviewed publications and numerous publicly available posters, available on our website.
This information is provided by RNS, the news service of the
Quick facts: ANGLE PLC
Market Cap: £83.81 m
NO INVESTMENT ADVICE
The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...FOR OUR FULL DISCLAIMER CLICK HERE