4370 Varsity Drive
Ann Arbor, MI 48108
United States of America, Michigan
Rubicon is committed to developing a better non-invasive tests for detection of cancer and other diseases. Rubicon’s strength is high throughput discovery/validation/and testing of multiple cancer biomarkers from plasma, serum, urine, and other sources of sub-nanogram quantities of tumor DNA. By focusing IVD development directly on clinical biofluids, Rubicon avoids “Fool’s Gold” biomarkers detectable only in cell culture or diseased tissue, and focuses from the outset on DNA methylation and other epigenomic signals present in blood and urine. These biofluid markers are present as a) circulating free DNA leaked from the tumor itself, b) circulating tumor cells, and c) other epigenomic signals of cancer or the body’s response to cancer. As a result conventional and unique epigenetic markers can be discovered and clinically validated using the same fluids that are necessary for non-invasive patient testing. These capabilities are unique to Rubicon.
The Rubicon test development pipeline depends on selectively amplifying all the methylated portions of the genome, using its proprietary MethylPlex library synthesis and amplification methods, followed by analysis by microarray profiling, next generation sequencing, or qPCR quantification of methylation at hundreds of promoters. Typically 2 mL of serum is adequate for discovery or clinical validation of an unlimited number of candidate biomarkers, or to reliably test patients for tens of biomarkers. The markers discovered or validated using the enzymatic MethylPlex approach can also be tested (with lower sensitivity) using conventional bisulfite methods.
Rubicon partners with other companies to provide methylation discovery and validation services, as well as to co-develop patient tests. To date Rubicon has discovered and out-licensed over 20 methylation biomarkers to partners. Typical service projects involve discovery and screening of hundreds of marker candidates in hundreds of clinical samples in a period of 3 – 5 months. Rubicon provides a unique service by performing these multi-analyte discovery and validation projects on single plasma or serum samples. Rubicon customers are able to use the results to develop their own bisulfite-based single-analyte clinical tests, or to license MethylPlex for use in IVDMIA tests.