UK-based liquid biopsy company Angle has reported positive findings from clinical study ANG-002, which assessed its Parsortix system for the capture and harvesting of metastatic breast cancer cells.
The study’s primary objective was to demonstrate the system’s ability to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients.
The 400 subject study also met its exploratory goals, where the cells harvested with the Parsortix system could be subsequently assessed using a variety of analysis techniques.
Angle said that the harvested cells were useful for the production of cDNA libraries with sufficient quality for use in RNA-seq evaluation. Complete bioinformatic analysis is set be carried out this month.
The study was intended to support a de novo submission to the US Food and Drug Administration (FDA) for approval of the Parsortix system’s use with metastatic breast cancer patients.
Discussions with FDA identified the need for further analytical studies to support the regulatory clearance. These studies are anticipated to be completed in the fourth quarter of CY19.
Angle founder and chief executive Andrew Newland said: “We are delighted with the positive results from the FDA clinical study. We are working to complete the remaining analytical study work and the full data analysis and interpretation so that an FDA submission can be made as soon as possible.
“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.”
In October last year, Angle reported results from a clinical study of its Parsortix system for non-invasive prenatal testing (NIPT). The system was able to harvest foetal cells from the peripheral blood of mothers to diagnose any foetal abnormalities.