OvcaTest: Early diagnosis of Ovarian Cancer Using Monoclonal Antibodies
There are more than 239,000 new cases worldwide of ovarian cancer each year, accounting for around 4% of all cancers diagnosed in women. According to estimates of the American Cancer Society (ACS), 22,440 women are expected to be diagnosed with ovarian cancer in the United States and 14,080 are expected to die from the disease in 2017. Although the incidence of ovarian cancer is relatively low (approximately 1 in 7,500 women), it is one of the most lethal gynecological cancers. This is due to the fact that it is almost always diagnosed at a late stage. The ACS figures show that when diagnosed and treated early, the five-year survival rate increases from 29.6% to 93.1%. Europe together with Northern America has one of the highest incidence rates of ovarian cancer in the world, making it an important public health issue.
We seek to have a direct impact on the early diagnosis of ovarian cancer when it is in the most curable stage, i.e when the disease has not spread to the lymph nodes or distant sites (stage I and/or II). In order to achieve this, a novel diagnostic test is required, one that has the required specificity and sensitivity in order to detect the disease when there is a small number of cancer cells present.
The proprietary technology is based on subtractive immunization and hybridoma technology in order to create novel monoclonal antibodies (mAbs), which are able to detect markers unique to cancer cells. At the present, all commercially available antibodies in cancer therapy are unable to identify only cancer cells, something which results into their inherent toxicity (toxic in the sense of attacking also healthy cells). Furthermore, all current antibodies are unable to detect cancer accurately at an early stage when it is mostly curable. We can have an impact on both areas.
The technology has three major advantages over conventional methods: 1) preservation of the cell membrane antigens in their exact native conformational state, 2) generation of mAbs exhibiting higher affinity and avidity than those created with the conventional methods and 3) mAbs generated are only against antigens found on the surface of tumour cells.
Proof of Concept
Three novel monoclonal antibodies (mAbs) have been developed for the early diagnosis, imaging and treatment of ovarian cancer (project funded by Stavros Niarchos Foundation). Unlike all other commercially available antibodies, these three mAbs specifically target only ovarian cancer cells. At the present, all current modalities of cancer therapy are limited by their inherent toxicity (e.g. chemotherapy, radiation). We have obtained our first proof of concept in a pilot clinical study of ovarian cancer patients with advanced disease. The results have shown that the mAbs against ovarian cancer detected the presence of disease markers in the blood of 9/11 patients tested.
Using the technology, the objective is to commercialize two diagnostic immunoassay kits for ovarian cancer using the lateral flow and competitive ELISA (Enzyme Linked Immuno-Sorbent Assay) immunoassay technologies. The assays will be less costly than available cancer biomarker tests, much simpler to run from non-medical trained personnel and will be non-invasive as all tests require only patient serum (blood) samples.