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Share Price: 15.75

Bid: 15.50

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Change: -2.25 (-12.50%)

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Angle reveals positive results from latest Parsortix study

Fri, 31st May 2019 09:53

(Sharecast News) - Liquid biopsy company Angle announced positive results from its 'Parsortix' FDA clinical study for metastatic breast cancer on Friday.The AIM-traded firm said the 400 subject ANG-002 clinical study was designed to support a De Novo submission to the United States Food and Drug Administration (FDA), seeking Class II regulatory clearance for its Parsortix system, for the intended use with metastatic breast cancer patients.It said the study achieved its primary objective to demonstrate the ability of the Parsortix system to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients.The study also achieved its exploratory goals, by demonstrating that the cells harvested from patient blood using the Parsortix system could be interrogated using different subsequent analysis techniques, including Wright-Giemsa staining of cytospin preparations for cytopathological evaluation, fluorescent in situ hybridisation (FISH) for evaluation of HER2/neu amplification status, and RT-qPCR for evaluation of cancer related gene expression levels.Angle said the harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation, with full bioinformatic analysis due in June.It said its ongoing discussions with the FDA as part of the De Novo process had recently identified additional analytical study experiments that would be needed to support regulatory clearance.It said it was "helpful" that those requirements were identified ahead of FDA submission.The additional studies had minimal cost, and were expected to be completed to allow FDA submission early in the fourth quarter, offering the prospect of FDA clearance in early 2020.Angle said the timing of FDA regulatory clearance was dependent on the FDA's review and response to its submission."We are delighted with the positive results from the FDA clinical study," said Angle founder and chief executive officer Andrew Newland."We are working to complete the remaining analytical study work and the full data analysis and interpretation so that an FDA submission can be made as soon as possible."Newland said the company believed there was a "tremendous opportunity" for Angle to secure the first ever FDA clearance for a platform that captured and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer."This clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate the Parsortix system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings."

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ANGLE Seeks To Strengthen Parsortix IP With Further Applications

LONDON (Alliance News) - Specialist medical technology company ANGLE PLC said Tuesday that it has taken steps to strengthen its intellectual property covering its Parsortix system. The company has filed claims covering new applications for the Parsortix system, including harvesting blood ce

17 Mar 2014 10:34

ANGLE Applies For In Vitro Approval For Parsortix In US

LONDON (Alliance News) - ANGLE PLC said Monday it has made a submission to the United States Food and Drug Administration for the authorisation of the sale of its Parsortix cell separation system as an in vitro diagnostic device in the United States. The specialist meditech firm has applied

24 Feb 2014 10:47

Angle Shares Up On Positive Test Results Using Parsortix

LONDON (Alliance News) - Shares in ANGLE PLC rose 6.7% Monday after it saw positive results using its Parsortix system to analyse Circulating Tumour Cells in the blood of metastatic liver cancer patients. The test, undertaken by Hari Nageswaran at the University of Surrey's Oncology departm

18 Feb 2014 12:41

UK MIDDAY BRIEFING: Inflation Below Target For First Time In 4 Years

LONDON (Alliance News) - The UK's inflation rate has fallen below the Bank of England's 2% target for the first time in more than four years Tuesday, a decrease that will support governor Mark Carney's recent prediction that the bank's interest rate won't rise for some time to come.

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18 Feb 2014 11:50

UK WINNERS & LOSERS: Randgold, Goldstone Fall As Drilling Results Disappoint

LONDON (Alliance News) - The following stocks are the leading risers and fallers within the main London indices midday Tuesday. ------- FTSE 100 - WINNERS BHP Billiton, up 1.2%. The Anglo-Australian mining giant has reported an 83% increase in profit for the first half of fiscal

18 Feb 2014 09:30

ANGLE To Launch Parsortix At Berlin Medical Conference Wednesday

LONDON (Alliance News) - Shares in ANGLE PLC were on the rise Tuesday morning, after the specialist med-tech company said it will launch its Parsortix non-invasive cancer diagnostic system at a science and medical researcher conference in Berlin on Wednesday. ANGLE's pretax loss widened in

30 Jan 2014 11:28

ANGLE Focused On Market Adoption For Parsortix As Loss Widens

LONDON (Alliance News) - ANGLE PLC said Thursday that it was focused on establishing widespread market adoption for its Parsortix cell separation system following marketing authorisation in Europe, as its pretax loss widened in the half-year ended October 31. Parsortix is a cell separation

30 Jan 2014 08:33

UK MORNING BRIEFING: BSkyB Up, Diageo Down Amid Lower Open

LONDON (Alliance News) - UK shares have opened lower Thursday, following the decision of the US Federal Reserve to continue tapering its asset purchases.

A large number of UK company reports at the open have seen a positive statement from BSkyB, up 2.4% at the open,

7 Jan 2014 08:40

ANGLE Appoints Scientific Adviser

17 Dec 2013 11:53

Angle wins EU authorisation for Parsortix

Medical diagnostic device maker Angle has won European approval for a system used in the diagnosis and treatment of cancer patients. Angle said regulators had authorized its Parsortix cell separation system for use as an in-vitro diagnostic device in the EU. The system uses blood analysis to diagn

13 Dec 2013 11:41

ANGLE sells Geomerics business to ARM Holdings

Specialist medtech company ANGLE has raised 6.2m pounds after realising its investment in graphics technology developer Geomerics, which it sold to ARM Holdings. The group said the additional financial resources will be used within its Parsortix non-invasive cancer diagnostics business, enabling i

13 May 2013 14:34

Angle shares jump on cell harvesting update

Shares in Angle, a specialist medtech company, leapt 20 per cent on Monday after the group said it has extended the operational capability of its Parsortix non-invasive cancer diagnostic product by automating its cell harvesting function. Harvesting is where captured tumour cells are recovered from

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