Australian diagnostics company HealthLinx Limited, along with researchers at the University of Liverpool, have just gotten word from the journal Clinical Science that their manuscript detailing the identification of a novel biomarker in ovarian cancer patients has been accepted for publication.
This means the company is now cleared to reveal the biomarker: anterior gradient protein 2 (AGR2). HealthLinx says its performance will be further tested in a forthcoming international biomarker study led by the company. Based on early data, however, this biomarker could increase the performance of the company's OvPlex diagnostic test to greater than 97 percent accuracy.
Here is the paper abstract:
Ovarian cancer is often asymptomatic and is diagnosed at an advanced stage with poor survival rates, thus, there is an urgent need to develop biomarkers for earlier detection of ovarian cancer. Here, we demonstrate for the first time that the previously-reported metastasis-inducing protein, anterior gradient protein 2 (AGR2), can be detected in the blood of ovarian cancer patients. Using a newly developed ELISA test, we show significantly increased concentrations of AGR2 protein in plasma from cancer patients relative to normal controls. Plasma AGR2 concentrations were highest in stage II and stage III ovarian cancer patients and were similarly elevated in patients with both serous and non-serous tumors. The identification of elevated plasma concentrations of AGR2 may provide a useful biomarker to aid in the discrimination of normal and ovarian cancer patients particularly when used in combination with CA125.
Ovarian cancer is a form of cancer that starts in the ovaries--the female reproductive organs that produce eggs--but that tends to exhibit scant, vague symptoms such as bloating and feeling full quickly. Treatment in any stage tends to involve some level of surgery to remove the cancerous cells, including total hysterectomies.
The discovery of this biomarker--what could be a real coup for ovarian cancer patients worldwide--is described by HealthLinx as a coup for, well, HealthLinx. In the words of managing and executive director Nick Gatsios:
This is a coup for the company. HealthLinx has a patent pending for what we view as a unique antibody that allows us to detect the protein in human blood. We have been working with this biomarker for almost two years and have been holding our cards very close to our chest until we were confident about its importance in our programs.
Clinical Science will publish the paper, called "Increased plasma concentrations of anterior gradient 2 protein are positively associated with ovarian cancer," in the forthcoming months, while a pre-print version is currently available online here.