ANGLE plc ("the Company")
ANGLE ACHIEVES WORLD FIRST WITH FDA CLEARANCE FOR ITS PARSORTIX® PC1 CLINICAL SYSTEM
FDA De Novo product clearance to harvest cancer cells from blood for subsequent analysis offers the prospect of a new era of personalized cancer care
Parsortix liquid biopsy system cleared for use in metastatic breast cancer
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is absolutely delighted to share that the US Food and Drug Administration (FDA) has cleared the Parsortix® PC1 Clinical System for its intended use with metastatic breast cancer (MBC) patients*.
This ground-breaking FDA clearance is the first ever FDA product clearance to harvest cancer cells from a patient blood sample for subsequent analysis and offers the prospect of a new era of personalized cancer care.
The Parsortix system's capability to harvest cancer cells for analysis from a patient blood sample has the potential to transform treatment decisions for cancer patients as it opens the opportunity for repeat non-invasive biopsies to assess cancer status. The Company believes intact living cancer cells are the "best sample" for analysis, adding vital additional information to the current industry approach of analyzing fragments of dead cancer cells (known as ctDNA).
The Parsortix system approach utilizes a unique technology developed, owned and patent protected by ANGLE.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"We are absolutely delighted that FDA has cleared the Parsortix system and believe this heralds a new era for personalized cancer care.
This ground-breaking first ever FDA product clearance in metastatic breast cancer provides the platform for ANGLE to work with our collaborators and customers to support further FDA submissions and the establishment of numerous specific clinical uses across different cancer types. By making the Parsortix system widely available, we intend to support the entire industry in its adoption of liquid biopsy solutions for repeat non-invasive diagnostics for personalized cancer care. Large-scale medtech and pharma companies now have an FDA cleared platform on which to develop new medical solutions.
We are most grateful to over three hundred metastatic breast cancer patients and several thousand healthy volunteer donors, who donated blood to allow us to achieve this major breakthrough in the adoption of liquid biopsy as a potential new standard in the care of cancer patients. We also thank investors for providing the considerable financial support, and patience, that has allowed us to undertake such a substantial exercise."
Dr. James M. Reuben, Professor, Department of Hematopathology, Division of Pathology/Lab Medicine, The University of Texas MD Anderson Cancer Center and co-PI of the trial commented:
"My lab's overarching interest is to develop assays that will serve as companion diagnostics to assist clinicians who treat cancer patients (MBC and non-small cell lung cancer) with therapies such as immune checkpoint inhibitors and targeted agents. Therefore, we have devoted considerable effort to developing multiple cellular assays utilizing CTCs which offer a minimally invasive approach to monitor a patient's cancer and their response to these therapies. Data from our trial with Parsortix showed the system was able to effectively capture a single cancer cell in a blood sample for analysis. We look forward to the further development of CTC based assays that may bring enormous benefits to patients with MBC as well as other cancers in the future."
Dr. Reuben receives research support from ANGLE, and he is compensated as a member of its Scientific Advisory Board. This financial relationship has been disclosed to MD Anderson's Conflict of Interest Committee.
Dr. Naoto T. Ueno, Professor, Department of Breast Medical Oncology, Chief of Section of Translational Breast Cancer Research, The University of Texas MD Anderson Cancer Centre and co-PI of the trial added:
"Liquid biopsy to collect circulating live cancer cells is an essential tool that we need to make advancements in understanding the biology of metastatic breast cancer. We anticipate that this announcement may help to develop novel biomarkers, therapeutic approaches and contribute to selecting the best treatment for metastatic breast cancer patients."
Dr. Julie Lang, Chief of Breast Surgery and Co-Director of Comprehensive Breast Cancer Program at Cleveland Clinic Cancer Center, and formerly Director, USC Breast Cancer Program, Associate Professor of Surgery, Norris Comprehensive Cancer Center, University of Southern California commented:
"In my team's research, we have demonstrated how circulating tumor cells harvested by this system are a good surrogate for tissue biopsies of the metastatic site. With this regulatory clearance we can now obtain repeat biopsies periodically to provide up-to-date information to guide treatment decisions, improving care and minimizing invasive procedures for these patients."
Dr. Massimo Cristofanilli, a pioneer and recognized leader in the field of liquid biopsy commented:
"Circulating tumor cells (CTCs) have long been recognized as a robust prognostic marker in metastatic breast cancer but its clinical application has been limited by the lack of predictive molecular information. MBC is a heterogenous disease that requires targeted and biological therapies and diagnostic monitoring of the natural molecular evolution of the disease to be able to longitudinally identify and implement the most effective treatment and measure its benefit. I believe that the Parsortix® PC1 system provides the ideal technology for such purpose allowing point of care diagnostic capabilities that capture the complexity of the ever-changing molecular landscape of MBC. In fact, I envision that the clinical application of the Parsortix® PC1 system can result in an unprecedented opportunity to perform a real-time molecular diagnostic assessment of enriched CTCs with comprehensive molecular information on both protein expression and genomic abnormalities driving the disease."
Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center, Wilmot Cancer Institute commented:
"As a leading translational research team, we have a long association with the team at ANGLE and are delighted to have played a key role in their clinical studies to bring the Parsortix system into clinical use. Real-time analysis of live circulating tumour cells offers the potential to transform patient care by enabling actionable information that can guide treatment decisions in heterogeneous and dynamic cancers such as MBC. FDA clearance is a major advance in cancer care, and we look forward to bringing this benefit to MBC patients as well as continuing to support further research into the advantages of CTC analysis using the Parsortix system"
*Parsortix® PC1 Clinical System Intended Use
The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate, or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.