Stage 1 of HealthLinx Limited’s multi-centre, multi-site second study for OvPlex has returned excellent initial data for the two new biomarkers AGR2 and HTX010 being evaluated for accuracy in diagnosing ovarian cancer. To date, AGR2 and HTX010 data have been analysed in over 400 case and control samples. Both AGR2 and HTX010 demonstrated statistically significant elevations in circulating plasma concentrations in both early stage (Stages I-II) and late stage (Stages III-IV) ovarian cancer patients.
These data are significant as they confirm and reinforce previous findings from several smaller pilot studies and now pave the way for HealthLinx to use these markers in its OvPlex multimarker panel. Previous modelling with these biomarkers demonstrated improved diagnostic efficiency of the OvPlex panel. In combination with the other OvPlex biomarkers we expect a marked improvement in the diagnostic efficiency in early (Stage I-II) ovarian cancer.
“Based upon our initial studies, we always believed that AGR2 and HTX010 would boost the performance of the OvPlex test. These early results are certainly in line with expectations and give us great confidence that our target of achieving a test with significantly enhanced diagnostic efficiency is feasible. Our aim is to fine tune the OvPlex test to ultimately provide sensitivity and specificity of at least 97% in the target patient population” said Nick Gatsios, Managing Director of HealthLinx.
Further development of the diagnostic use of AGR2 is of particular relevance as Healthlinx is the exclusive licensee of intellectual property covering the use of a highly specific monoclonal antibody that forms the basis of the blood test it has developed. HealthLinx has already signed a non-exclusive license deal for the use of one anti-AGR2 monoclonal antibody for research purposes to the Millipore Corporation, one of the world’s largest research reagent companies.
Based on these data, HealthLinx will now move forward with plans to further develop and partner the AGR2 immunoassay as a clinical diagnostic tool with a range of potential applications related to cancer diagnosis and monitoring.
“There are a range of potential applications emerging for the use of AGR2 as a cancer diagnostic. Although we are examining its potential diagnostic relevance in ovarian cancer patients, some characteristics of AGR2 expression suggest that it could be of value as a diagnostic/prognostic indicator in other cancer patients,” said HealthLinx chief scientific officer Dr Dominic Autelitano.
“It is very encouraging to see that the preliminary stage 1 data of the larger biomarker trial upholds and reinforces our initial ideas about AGR2 and HTX010. The next set of data analysis encompassing all of the original OvPlex multimarker panel is expected before the end of this quarter,” said Dr Autelitano.
Date: November 15, 2010
Source: HealthLinx Limited