In a similar study last year, Parsortix demonstrated a correct prediction of cancer of 95.1% with higher sensitivity and specificity (or fewer false positives) than any other test available for the same application.
Since then, ANGLE has been optimising the liquid biopsy which it hopes will further improve the accuracy this time around.
To start with, 70 patients with a pelvic mass will be tested to see if the lump is cancerous or not. This will then be followed by a 200-subject clinical study.
The first subjects have already been enrolled and ANGLE expects the study to complete in the first quarter of 2020.
Should the results confirm Parsortix’s accuracy in screening for cancers, ANGLE plans to begin partnering discussions with large clinical laboratories and women’s health companies.
ANGLE would then use the partner’s sales and distribution channels to scale deployment of its device.
Boss ‘very excited’
“The planned 200-subject study is designed to verify the clinical performance of the novel ANGLE ovarian cancer assay in discriminating malignant from benign pelvic masses prior to surgery,” said Richard Moore, the director of the Gynecologic Oncology Division at the University of Rochester Medical Center Wilmot Cancer Institute.
“The test's high sensitivity and specificity, demonstrated in a previous study presented at the 2018 SGO annual meeting, will help to ensure that women with ovarian cancer get the best possible specialist treatment whilst women with a benign condition will be able to have their treatment locally with the physicians they know.”
ANGLE founder and chief executive Andrew Newland added: “The performance of the HyCEAD Ziplex system in conjunction with Parsortix endorses the company's decision to acquire the platform and opens a wide range of commercial opportunities.
“The first clinical application in ovarian cancer is an exemplar with a large opportunity for ANGLE and we are excited about progressing the clinical verification study.”
Significant milestone, says broker
“This [study] is a significant milestone and in line with comments made at its interim results in January,” said finnCap analyst Mark Brewer.
“We reiterate our 110p price target and await eagerly for confirmation that the FDA breast cancer study has completed enrolment, expected in Q1 2019.”
ANGLE shares were unchanged at 54.5p in early deals on Thursday.