HealthLinx reports strong results from ovarian cancer study

Shares in diagnostics company HealthLinx surged 18 percent today after the company announced positive results from its independent, multi-centre, multi-site second study for OvPlex based on two new biomarkers being evaluated as diagnostics for ovarian cancer.

The company said that “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”.

The data follows previous findings from a number of smaller pilot studies, paving the way for Healthlinx to use these markers in its multi-marker panel, OvPlex. HealthLinx said that previous modelling based on AGR2 and HTX010 showed improved diagnostic efficiency of the OvPlex panel, with the company stating that it expects to see “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,” HealthLinx managing director Nick Gatsios said.

“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 percent in the target patient population”.

HealthLinx also noted further opportunities stemming from the development of AGR2 as a diagnostic, given that the company is the exclusive licensee of IP covering the use of a “highly specific monoclonal antibody”, upon which its blood test is based. The company recently signed a non-exclusive license deal allowing the Millipore Corporation to use one of its anti-AGR2 monoclonal antibodies for research purposes.

HealthLinx said that it would now progress with plans to further develop and partner the AGR2 immunoassay as a clinical diagnostic tool targeting cancer diagnosis and monitoring.

“There are a range of potential applications emerging for the use of AGR2 as a cancer diagnostic,” according to HealthLinx chief scientific officer Dr Dominic Autelitano.

“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”.

“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 multi-marker panel, is expected before the end of this quarter.”

HealthLinx’s shares closed today up 18 percent to $0.092.