Cancer & Therapy
According to the World Health Organization approximately 25 million people live with cancer in Japan, Europe and North America. Every year more than 7.6 million people die from cancer and 12 million new cases are diagnosed. Cancer is responsible for 12% of all deaths in the world and is the second most common cause of death in industrialized countries. With the general ratio of deaths to new cases at 49% overall it is obvious that there needs to be an improvement in current cancer therapeutics. Therefore, more efficient methods for the evaluation of cancer treatment efficacy are required. AroCell is developing and commercializing new innovative biomarkers for cell growth and apoptosis, which are clinically valuable for the prognosis, monitoring and follow up of cancer patients.
In 2007, the world market for cancer diagnostics was worth almost five billion USD. The potential market of a clinically valuable cancer marker is 400 MUSD. The worldwide sales of the AroCell products five years after launch are estimated to about 300 MSEK.
Cancer is signified by uncontrolled cell growth, and thereby increased concentration of thymidine kinase (TK). The rate of cell growth is directly linked to the aggressiveness of the tumor. Numerous methods for detecting cancer are currently being employed, using assays that detect the presence of tumor specific markers. All of these markers, including imaging techniques, are based on tumor mass. A marker that specifically detects tumor cell growth, which is directly related to the aggressiveness of the tumor, represents an important complimentary tool for cancer monitoring.
The TK 210 technology is based on a unique discovery, which makes it possible to measure thymidine kinase (TK) by an ordinary immunoassay. TK is the only marker for cell growth that can be detected in a normal blood sample. The clinical relevance has been successfully demonstrated in more than ten different cancer forms. The AroCell product will offer a unique opportunity to determine increased cell growth and, thereby, cancer activity with very high sensitivity.
AroCell owns all relevant patents and IP for the test technology. In total there are three patent families. Two of them describe the development of antibodies against the two important antibody binding sites/epitopes of the molecule. The third is an application patent describing early detection of breast cancer metastasis.
AroCell is developing a series of tests for prognosis and monitoring of cancers. The first product, TK 210/hem ELISA for hematological cancers, was introduced as a research product in January 2012. The format is an ELISA test. The product will be used for clinical evaluations and documentation. A commercially available CE-labeled, product will be launched in Q4 2012. TK 210/hem ELISA will be sold by a net-work of selected distributors. AroCell will also license out the rights to the new, unique marker to selected diagnostic companies to be adapted to their own automated platforms, which are placed in all routine clinical laboratories.
When the first product TK 210/hem is successfully launched development of the second product TK 210/prostate will start. This project is based on discoveries during development of the TK 210/hem ELISA, which are related to pre-treatment of the samples and specificities of the monoclonal antibodies. These findings can also be used to develop other assays specific for different cancer forms. In parallel with the development of new TK assays a research project will be started together with Staffan Eriksson at the Swedish University of Agricultural Sciences with the aim to find new complementary cell proliferation and apoptosis markers.
Another business opportunity is the development of a Point of Care Test (POCT) based on the TK 210 technology with a new large potential market. A final decision regarding the POCT will be taken in 2013.