Direct comparison of a simple blood test processed with the Parsortix system with invasive solid biopsy of the metastatic site delivers comprehensive gene expression analysis
Leading US cancer center, the University of Southern California Norris Comprehensive Cancer Center presents data at the world-renowned San Antonio Breast Cancer Symposium
ANGLE plc, announced that the University of Southern California (USC) Norris Comprehensive Cancer Center yesterday presented results of extensive work with ANGLE’s Parsortix™ system at the San Antonio Breast Cancer Symposium (SABCS) detailing how the system can be used to obtain comparable gene expression information from a simple blood test in place of an invasive solid tissue biopsy of a metastatic site.
USC made a direct comparison of extensive gene expression information from the biopsy of the metastatic site with that from a blood test processed with the Parsortix system. Information from the blood test using the Parsortix system “did not show significantly different patterns of expression” compared to the invasive biopsy of the metastatic site. 66 clinically actionable genes in 7 different signalling pathways were measured addressing the key areas that clinicians currently investigate.
ANGLE is working towards an FDA clearance of the Parsortix system in metastatic breast cancer with the required analytical and clinical studies targeted for completion by 30 June 2018. ANGLE is seeking to become the first company ever to receive FDA clearance for a medical device to harvest cancer cells from patient blood for subsequent analysis. The ground-breaking work presented by USC at SABCS demonstrates the importance of being able to harvest and analyse these cells from patient blood.
Julie E. Lang, MD, FACS, Director, USC Breast Cancer Program, Associate Professor of Surgery, Norris Comprehensive Cancer Center, University of Southern California, commented:
“Our study showed that we are able to use a Parsortix liquid biopsy of circulating tumor cells to perform in-depth characterization of potentially clinically actionable treatment opportunities in metastatic breast cancer patients. We demonstrated that circulating tumor cells may serve as a surrogate for biopsies of macrometastases. Successful validation of our approach in future clinical studies could revolutionize clinical management of metastatic breast cancer and advance the promise of personalized cancer therapies, ultimately positively changing the outcome for patients with metastatic disease.”
ANGLE Founder and Chief Executive, Andrew Newland, commented:
“USC’s ground-breaking work with ANGLE’s Parsortix system over the last two years has delivered convincing data that a simple blood test may be able to provide all the clinical information traditionally provided by the invasive, expensive solid biopsy. This is great news for ANGLE as it gives a clear guide to the importance of being able to harvest and analyse these cells from patient blood.”
USC’s poster for SABCS is available online at https://angleplc.com/library/publications/. Key points are summarised below.
The solid biopsies for comparison had to be sourced from numerous different secondary cancer sites including skin, lung, pleural effusion (fluid around the lung), pericardial effusion (fluid around the heart), breast, lymph node, brain, liver, ascites, cerebrospinal fluid (fluid found in the brain and spine) and bone tissue. Gathering this material is an invasive surgical procedure and many women are not well enough to undergo the procedure.
Good RNA expression was obtained from 19/21 of the Parsortix liquid biopsy samples, which is a level of performance that has not been seen previously. The RNA-Seq downstream process used is one of the “subsequent analyses” being evaluated in ANGLE’s ANG-002 400 subject clinical study for FDA clearance.
The US National Cancer Institute has estimated that, as at 1 January 2017, more than 150,000 women in the United States were living with metastatic breast cancer and this number is rising. There is a similar level of incidence worldwide. If a regulatory cleared blood test were available all of these women would be candidates for such tests, repeated on a periodic basis during the course of their metastatic disease.
ASCO (American Society of Clinical Oncology) guidelines call for biopsy of a metastatic site to guide the decision making for treatment as it is known that cancers change their status as disease progresses. Access to the secondary cancer site to obtain this tissue biopsy is challenging and requires the patient to undergo an invasive procedure, which causes trauma and delays treatment until they have recovered from the procedure. Furthermore the surgical intervention takes time to arrange, is expensive and diverts resources from care for the patient.
Consequently there is a major market need for a blood test alternative which can provide the same or better information non-invasively. Such a blood test would be non-invasive and could be repeated as often as was needed.
Source – Market Wired