In December 2016, the US division of Japanese life sciences company Takara Bio Inc., acquired private US genomic analysis company in an all cash deal. Rubicon Genomics had been in the business of developing improved technologies for detecting the pattern of DNA methylation in cancer cells. The firm developed a test to non-invasively to diagnose cancer and other diseases using its proprietary MethylPlex technology to amplify the exceedingly small amounts of abnormally-methylated DNA that are released by diseased tissue into serum and urine. MethylPlex has proven sensitivity and simplicity advantages over current competitive tests for methylated DNA tumor markers. The increased technical sensitivity could enable earlier, more reliable non-invasive detection of disease as well as allow for more methylation markers to be assayed in a single test, thus increasing both diagnostic sensitivity and specificity. The increased simplicity of MethylPlex enables inexpensive, robust tests utilizing currently existing diagnostic platforms. Achievement of these sensitivity and simplicity milestones make MethylPlex the first cancer diagnostic tool to meet the performance and cost criteria required for population screening. MethylPlex is the diagnostic flagship of the OmniPlex family of Rubicon amplification technologies. Rubicon has developed patient tests that employ previously-discovered methylation markers, and will develop future tests based on proprietary markers that Rubicon is currently discovering on custom microarrays that profile methylation of all human genes. This strategy is built on the belief that methylated DNA in serum and urine is a universal analyte for disease diagnosis and prognosis. Rubicon has protected MethylPlex and the other members of the OmniPlex family by international patents and patent filings. Rubicon is committed to the development of highly sensitive and specific non-invasive tests for cancer using its proprietary MethylPlex technology. The MethylPlex tests will initially focus on serum and urine samples, since these are universally available fluids that contain very small amounts of tumor DNA which is released into the bloodstream and subsequently excreted. The Company plans to develop tests for multiple diagnostic and prognostic applications, taking advantage of the known importance of methylated DNA (meDNA) in the progression of almost all types of cancer, as well as the known deficiencies in sensitivity and cost of current tests to detect meDNA in blood and urine. Rubicon is initially developing MethylPlex to detect prostate and bladder cancer because of the high cost and non-optimal utility of surgical biopsies of these tumors. Furthermore, abundant data support the idea that a simpler molecular test with improved technical sensitivity for detection of meDNA in serum and urine could have the diagnostic sensitivity and specificity to be a significant improvement over other non-invasive testing protocols, such as the PSA test, cytogenetics and conventional tests for meDNA. In addition to these development efforts, the Company has commercialized GenomePlex and TransPlex research kits, which are based on the Companys proprietary amplification technology and are used for whole genome and whole transcriptome amplification, respectively. Rubicon has entered into a license agreement with Sigma-Aldrich for the manufacture, sale and marketing of GenomePlex for research applications, and is currently seeking a partner for sale of TransPlex for the research market. In addition to these product sales, the Company operates a contract service for whole genome and whole transcriptome amplification using its proprietary technologies.
