ANGLE PLC (AIM:AGL, OTCQX:ANPCY) has scored a world first by achieving US Food & Drug Administration clearance for its Parsortix liquid biopsy system – a technology that is able to harvest cancer cells from a simple blood sample.
The company reckons the De Novo approval from the American regulator heralds a new era for personalised cancer care.
It also provides ANGLE with first-mover advantage in market expected to grow to US$100bn in the US alone.
Unsurprisingly, the shares shot up 34%, valuing the business at more than £300mln.
The ability to harvest and analyse circulating tumour cells from a blood draw opens the opportunity for repeat, non-invasive monitoring of people with cancer.
The company said it believes intact living cancer cells are the best sample for analysis, adding vital additional information to the current industry approach of analysing fragments of dead cancer cells, known as ctDNA.
The FDA product clearance is for metastatic breast cancer, but ANGLE said it provides the platform for it to work with its collaborators and customers to support submissions to the American drug regulator.
The idea would be to establish Parsortix for use across multiple 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 personalised cancer care,” said Andrew Newland, the company’s chief executive and founder.
“Large-scale med-tech and pharma companies now have an FDA cleared platform on which to develop new medical solutions.”