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ANGLE on track to conclude FDA study by year-end

Sign-off by the US Food & Drug Administration is considered the "global standard for approval", the company said
tumour cells
The company is an expert at harvest tumour cells found in the bloodstream

Med-tech specialist ANGLE PLC (LON:AGL) has confirmed it is on target to complete by the end of the year a US Food & Drug Administration study of cancer detection device, Parsortix.

A total of 400 people at four leading oncology centres are taking part in the trial, which its hoped will help the company gain Class II clearance for the device, which harvests intact circulating tumour cells.

“Clearance by the FDA is considered the global standard for approval of medical diagnostic systems and ANGLE believes that such clearance would provide ANGLE's Parsortix system with a further competitive differentiation, which would accelerate all forms of commercial adoption of the system in both research and clinical settings,” the company said.

The update was provided alongside full-year results, which showed the company was on a sound financial footing as well as making significant progress operationally.

Ovarian cancer study success

In the year ended April, the R&D team successfully concluded the 400-patient US and European ovarian cancer study, which delivered 95% accuracy identifying benign and malignant pelvic masses. This was significantly better than the current standard of care.

ANGLE has also added some complementary technology to its portfolio following the acquisition of Axela Inc for £3.6mln.

Axela’s main asset is the Ziplex platform, which allows gene expression analysis of cancer cells.

International tie-ups 

Internationally, the company is being recognised for its expertise and has an installed base of Parsortix devices that has grown to 200 from 145 last year.

Alongside academic tie-ups, it now has collaborations with pharma and biotech big hitters QIAGEN, Philips and Abbott.

As is to be expected of a company that’s attempting to prove the clinical and commercial worth of a potential breakthrough device, ANGLE was loss-making. In the 12 months to April 30, the deficit was £7.5mln.

It generated modest revenues and grant income of £700,000. More importantly, it had £7.6mln in the bank at the period-end and has gone out and raised a net £12mln. In other words, it is well-funded.

Continued investment 

"With two successful ovarian cancer studies, the initiation of our FDA clinical studies and three global healthcare companies secured as partners, ANGLE has established worldwide recognition and potential,” said chairman Garth Selvey.

“The acquisition of downstream analysis technology complements the Parsortix system and will, in time, allow us to offer our customers a full 'sample to answer' solution.

“We continue to invest heavily to pursue FDA clearance for the Parsortix system as the first ever FDA cleared clinical device to harvest intact circulating tumour cells for analysis from patient blood.

“Commencement of clinical trials at four prestigious US cancer centres marks a major step forward for the business."

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