LONDON (ShareCast) - (ShareCast News) - Biopsy company ANGLE announced positive headline results from 400 patient pelvic mass studies in the US and Europe on Tuesday, reportedly demonstrating the potential for a 'Parsortix'-based blood test to outperform current tests in discriminating between benign and malignant pelvic masses.
The AIM-traded firm said evaluation of data from both ANGLE's European study (ANG-001) led by Dr Robert Zeillinger at the Medical University of Vienna and ANGLE's US study (ANG-003) led by Dr Richard Moore at the University of Rochester Medical Center, Wilmot Cancer Institute in New York showed that a test using the Parsortix system could differentiate between women with a malignant pelvic mass and those with benign tumours with a high degree of sensitivity - correctly identifying cancer - of up to 95%, while at the same time achieving a higher specificity, i.e. a low false positive rate, compared to existing tests.

Compared to the existing CA125 test for the ANG-003 samples, at a high sensitivity the Parsortix result had nearly double the specificity of the CA125 result, the board claimed.

It said the study results inferred that best performance could be achieved when combining selected gene information analysed from the Parsortix harvest in an algorithm with certain patient condition information.

The algorithm, which is proprietary, would be further optimised to give the best performance in the upcoming validation study, ANGLE explained.

It expected that it would be possible to apply for patent protection on the details of the algorithm strengthening ANGLE's competitive positive further, and as such full details of the analyses were being restricted until that process is complete.

The cancer centres involved would then publish the full results of the studies in leading peer-reviewed publications.

"The 200 patient ANG-001 clinical multi-centre study has shown that the Parsortix based test allows us to successfully discriminate patients with ovarian cancer from patients with a non-malignant pelvic mass with a high degree of accuracy," said Professor Robert Zeillinger, head of the Molecular Oncology Group at the Department of Obstetrics and Gynaecology, Medical University of Vienna.

"Using ANGLE's Parsortix system and a panel of RNA markers, there is the prospect that we can meet a key medical need in triaging women before surgery to ensure patients with cancer get the care they need."

ANGLE said the successful results would enable it to move into the next phase of development of a commercial blood test, addressing an estimated market size of £300m per annum.

Firstly, the test would be optimised to maximise performance, with some key aspects of the downstream analysis techniques identified as candidates for enhancement to improve the performance of the assay and provide an "even stronger" competitive advantage.

The performance of the optimised test would be confirmed utilising a second blood sample that has been banked from each of the ANG-003 study patients.

ANGLE said the performance of the optimised test would then be validated in a separate set of patients through the conduct of appropriately-powered validation studies designed to meet European CE Mark and US FDA regulatory requirements.

Successful completion of those validation studies would allow the commercial sale of the Parsortix based pelvic mass test in the United States and Europe, and eventually worldwide.

"ANGLE's first large scale clinical studies of 400 patients have demonstrated positive results with the potential to out-perform current standard of care," said founder and chief executive Andrew Newland.

"This success enables ANGLE to move forward into the validation phase for the use of Parsortix in its first clinical application.

"We believe ANGLE is building momentum towards securing a leading and well differentiated commercial position in the emerging multi-billion dollar liquid biopsy market."

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