ANGLE plc receives first US FDA marketing authorization for its circulating tumour cell harvesting Parsortix System for use with Metastatic Breast Cancer patients

ANGLE plc receives first US FDA marketing authorization for its circulating tumour cell harvesting Parsortix System for use with Metastatic Breast Cancer patients

• Liquid biopsy is an emerging approach to cancer diagnosis and monitoring and could enable repeat biopsies for evaluating certain types of solid tumours as they develop over time allowing personalised care for the patient improving outcomes and reducing costs. The technique’s relative advantages are:
• It can be repeated as often as required to ensure personalised treatment decisions.  This is impossible with tissue biopsy as it cannot be repeated.
• It is markedly less invasive and burdensome as it doesn’t involve surgery and recuperation is minimal.
• It is more accessible as the blood sample can be taken in a doctor’s surgery rather than in hospital with the subsequent Parsortix harvesting and analysis steps performed remotely (particularly pertinent given the recent experience of cancer diagnosis delays due to very restricted hospital access resulting from the pandemic).
• Additionally, Parsortix enables biopsies to be performed in settings where solid tissue biopsies are not feasible. E.g., c.50% of all metastatic breast cancer patients following surgical removal of the primary tumour are unable to have a solid tissue biopsy of the metastatic site.
• Performing a liquid biopsy is also relatively cheap for payors as surgery and hospitals stays are avoided. For instance, in the case of metastatic breast cancer, the average cost associated with a solid tissue biopsy (if feasible- see above) is $16,000 in the US. The Parsortix liquid biopsy procedure will be offered at a substantially lower cost than this.

• The Parsortix system has so far been deployed in research studies reported in 54 peer-reviewed publications by 29 independent cancer research centres. While 17 of these peer-reviewed publications have involved breast cancer including 15 in metastatic breast cancer, Parsortix has also been used by researchers to successfully harvest CTCs in 24 different types of solid tumour including ovarian cancer, prostate cancer, lung cancer and head & neck cancer. Use in cancer types other than metastatic breast cancer is not yet FDA approved.

• The information available through analyses performed on CTCs is additional to that obtained from ctDNA and ANGLE has established that the same blood sample could be used to perform both, if required.
• A typical 10ml tube of patient blood can be separated into cellular and plasma fractions.
• The plasma fraction is used for ctDNA testing.
• The cellular fraction could be submitted for Parsortix processing enabling analysis of intact, harvested CTCs, if present.
• ctDNA analysis provides information on DNA and mutations. Analysis of CTCs can additionally provide important information on RNA expression (is the DNA mutation expressed) and protein expression (the targets of many cancer drugs).

• This grant of US marketing authorization arises from a “De Novo Classification Request” to the FDA. This regulatory route is one used when there is no legally marketed predicate device. Devices receiving marketing authorization in this way may then be cited as a predicate for future 510(k) submissions. If the data is supportive, it is envisaged that expansion of use for the Parsortix System with patients with different tumour types will utilize this latter, typically quicker, regulatory authorization pathway.

• A solid tissue biopsy is currently performed for any solid tumour cancer type along with lymph node and distant metastatic lesion testing, where appropriate. This includes breast, lung, colorectal, gastric, pancreatic, head and neck, brain, bone, renal, liver.

• Breast cancer is the leading cause of cancer worldwide with 2.2 million new cases estimated in 2020. MBC is responsible for virtually all breast cancer deaths and for the 6% of patients diagnosed with metastatic disease or patients whose disease has progressed to stage IV, 5-year relative survival is only 29%.

ANGLE estimates that the immediate addressable market for the Parsortix system used with metastatic breast cancer patients could reach in excess of $500m per annum in the United States alone. Research estimates the market opportunity for liquid biopsy in the United States alone to be more than $100bn per annum.