The US Food and Drug Administration has approved a blood diagnostics device developed by ANGLE PLC (AIM:AGL, OTCQX:ANPCY) that can identify metastatic breast cancer in patients.
UK-based biotech company Angle’s Parsortix technology is the first product ever to be cleared by US regulators that harvests cancer cells from a blood sample.
It offers the possibility of non-invasive biopsies that analyse patient blood samples rather than removing cells as part of a surgical procedure. The patented Parsortix technology has been cleared for use on metastatic breast cancer and is fully owned and developed by the company.
The new technology could usher in a new era of personalised cancer treatment, according to Angle’s founder and chief executive Andrew Newland.
“We’ve very pleased that the pharma services business we set up last year has started to gain significant traction already,” he said on a call with analysts on Wednesday afternoon.
Newland expects that initial monetisation of the newly accredited technology is likely to come from its pharmaceuticals business before the technology is adopted more widely in a clinical setting.
The company is “in discussions with a number of larger medtech companies” over licensing the product and sending samples to its laboratories, he said on the conference call.
These potential contracts, some of which he said are with “billion-dollar revenue pharma”, represent potentially several thousand samples taken over a number of years.
Alongside its licensing business, Angle is building two clinical laboratories that are expected to have capacity to generate between $50m and $100m of revenue on an annual basis, Newland said.
Its clinical arms in the UK and US are designed to demonstrate and offer commercial viability for its blood diagnostics products.
Newland said it expects to have the first product offering in place “by the end of the year”.
While most of its customers will use the technology as part of exploratory usage, Newland said he hopes they will become a “critical part” of future cancer trials and that specialist hospitals will send blood samples to its labs.
The pharmaceuticals services business that Angle set up last year has begun to “gain significant traction already”, he said, securing five independent customers which are interested in targeting proteins in blood samples.
Although currently a relatively niche market in the biotech space, the so-called global “liquid biopsy” market is estimated to grow to more than $100 billion per year in the US.
Julie Lang, chief of breast surgery at Cleveland Clinic Cancer Center, said: " With this regulatory clearance we can now obtain repeat biopsies periodically to provide up-to-date information to guide treatment decisions, improving care and minimising invasive procedures for these patients."
Nearly 2.3mln new cases of breast cancer are diagnosed each year and Angle estimates that its technology could address a market of US$500mln in the US each year alone.
Shares in Angle rose 59% to 156.5p.