Breast cancer is the most commonly diagnosed cancer in women in the UK, one in eight women will develop it at some point in their lifetime according to Cancer Research.
Despite huge leaps in treatment and recovery rates, 1,000 women in the UK still die of breast cancer every month.
For many patients, fast diagnosis is key to early and full recovery.
A cutting edge blood test developed in the UK could replace painful biopsies in the diagnosis of metastatic breast cancer, an American study has shown.
The University of Southern California Norris Comprehensive Cancer Center has been testing the Parsortix device, developed by AIM-listed ANGLE PLC (LON:AGL OTCMKTS:ANPCY), to harvest tumour cells circulating in the blood stream for an effective diagnosis.
The results showed a statistically significant correlation between analyses of circulating tumour cells from a blood test compared with tissue obtained by invasive biopsies of secondary tumour sites.
Aiming for FDA approval
Parsortix performed well in head-to-head trials which compared it to current methods of assessing for cancer spread.
Parsortix is also being used to identify ovarian cancer, while Cancer Research’s Manchester Institute is using Parsortix in 10 clinical trials, with another four on the cards.
Regulatory clearance from the US Food and Drug Administration (FDA) would open the market up for the breakthrough device.
Analytical and clinical study programmes have been designed to garner FDA sign-off with ANGLE receiving help in these efforts from three world-leading cancer centres.
Initially, the group is looking for the go ahead to use Parsortix to detect metastatic breast cancer.
Avoiding painful biopsies
A biopsy is often a painful and invasive surgery to remove a sample of the affected tissue for testing.
ANGLE will now work with the University of Southern California and other leading cancer centres to perform clinical studies to validate the use of the Parsortix system as a routine biopsy for metastatic breast cancer. The studies are expected to take at least 18 months.
The ability to carry out simple blood testing using ANGLE’s Parsortix system would avoid the various complications that come with a traditional biopsy.
Surgical biopsies can leave scarring and is a painful procedure in itself, enhancing the suffering a patient is already enduring.
Metastasis, the shedding of tumours cells and the subsequent spread around the body, is responsible for the vast majority of breast cancer deaths.
Treatment tends to be tailored to the biology of the initial tumour, but as it seeds around the body the cancer changes characteristics. Drug guidelines now state that sample tissue is taken from an area where the cancer has spread, so the drug regimen can be altered.
Cancers can shed tumour cells and fragments of DNA into the blood system, the more advanced the more likely these cells can be found in the blood.
The Parsortix system uses a patented micro-fluidic technology in the form of a disposable cassette to capture and then harvest circulating tumour cells from blood. The cassette captures CTCs based on their less deformable nature and larger size compared to other blood components, using a patented separation step that acts as a kind of filter.
Using the system, doctors can get the same information one would get from a biopsy, but through a simple blood test.
It has the potential to reduce the time it takes to make a decision on treatment and allows the analysis of all cancer cells, not just the biopsy site, thus increasing the efficacy of tailored therapies and patient recovery.
Cheaper than surgery
Crucially, it would be much cheaper than surgery. Surgical biopsy in the US costs insurance companies around $3,500 and in the UK it can cost the NHS in excess of £1000, not including consultant and follow-up fees.
The disposable cassette costs very little in itself, meaning the overall cost of testing (including the use of the machine) is a fraction of the cost of surgery.
Not to mention reducing the risk of initial treatment failing and the associated cost of prolonged or alternative therapy.
The Parsortix system would be a welcome addition to an oncologist’s armoury in the fight against cancer. It could significantly reduce patient discomfort and speed up diagnosis, removing the need for time and resource consuming surgery.
In preliminary results released in July, ANGLE reported its first commercial sales, which contributed to the £400,000 of generated revenues.
The cash balance at April stood at £3.8mln; however, it has strengthened its financial position since by raising £10.2mln from institutional investors.
As is common with companies at this formative phase of development, ANGLE was loss-making. The deficit was £5.1mln.
"When there is more clarity about commercialisation in terms of timelines and positioning, we will review our financial forecasts and the assumptions underlying our DCF-based valuation, which is unchanged at £95mln or 161p/share for now," said investment analysts Edison.