Biomarker testing plays a key role in cancer diagnosis and prognosis, and is an essential factor in therapy selection. Of the top 20 oncology products, targeted therapies using predictive biomarkers captured a market share of 43% in 2012. Global sales of Herceptin (breast, gastric); Tarceva and Iressa (NSCLC); Zelboraf (malignant melanoma); and Erbitux (CRC) were approximately $10.4B in 2012. Half of the oncology agents granted Breakthrough Therapy Designation by the FDA in 2013 were targeted therapies with associated companion diagnostics.
We plan to enable personalized medicine and targeted therapies for mCRC patients based on the discovery of a predictive biomarker at UCSF and the development of a robust diagnostic test for this biomarker.
Currently, all mCRC patients are routinely tested for the presence of KRAS mutations, and only those patients with wild type KRAS genes are indicated to receive anti-EGFR therapy, the current standard of care in targeted therapy for colon cancer. However, less than 50% of these patients actually respond to this expensive targeted therapy. It is unclear why certain patients with wild type KRAS genes respond more effectively to anti-EGFR therapy than other patients with wild type KRAS genes. Based on the work of scientists at UCSF, a prognostic cancer biomarker – RASGRP1 – has been discovered, which we believe will improve the current mCRC diagnostic paradigm and more accurately identify patients who are most likely to respond to anti-EGFR therapy.
Our product- the RasGRP1 Diagnostic Assay – will help identify those patients that will respond to anti-EGFR therapy and those for whom an alternative therapy would be a better therapeutic intervention resulting in improved clinical outcomes.