Liquid biopsy company Angle plc, Guildford, UK, has announced results from a clinical study of its Parsortix system for detecting metastatic breast cancer.1 The 400-subject ANG-002 clinical study is designed to support a de novo premarket submission to FDA, seeking Class II regulatory clearance for Angle’s Parsortix system for intended use with metastatic breast cancer patients.
The study achieved its primary objective of demonstrating the ability of the Parsortix system to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients. It also achieved its exploratory goals by demonstrating that the cells harvested from patient blood using the Parsortix system could be interrogated using several subsequent analysis techniques, including Wright-Giemsa staining of cytospin preparations for cytopathological evaluation, fluorescence in situ hybridization (FISH) for the evaluation of HER2/neu amplification status, and reverse transcription polymerase chain reaction (RT-qPCR) for the evaluation of cancer-related gene expression levels. The harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation.
Angle’s ongoing discussions with FDA as part of the de novo process have recently identified additional analytical study experiments that will be needed to support FDA clearance. According to the company, the additional studies have minimal cost and are expected to be completed in time to allow FDA submission early in the fourth quarter of this year, offering the prospect of FDA clearance early in 2020.
Further disclosure of study data will be reserved in order to optimize the potential for publication in peer-reviewed journals, and for presentation of the data at leading cancer conferences.“We are delighted with the positive results from the FDA clinical study,” says Andrew Newland, Angle CEO. “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 tumor cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer,” adds Newland. “This clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate the Parsortix system, and should lead to an acceleration in commercial adoption of the system in both research and clinical settings.”
For further information, visit Angle.
- Harvest of circulating tumor cells (CTCs) from patients with metastatic breast cancer (MBC) using the Parsortix PC1 system (Homing). Guildford, UK: Angle plc, 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03427450. Accessed July 29, 2019.
The Parsortix PC1 instrument from Angle plc.