Rubicon Genomics has invented a more effective technology for the diagnosis and prognosis of cancer compared to what hospitals and reference laboratories use today. MethylPlex™ is the most sensitive method in use to detect the patterns of abnormal DNA methylation arising in the serum and urine of patients during tumor formation and progression.
The simplicity of MethylPlex testing overcomes the barriers of time and cost that have made cancer screening based on DNA methylation impractical until now.
"DNA methylation is potentially the most sensitive and specific indication for early cancer detection and prognosis," explains Dr. Vladimir Makarov, Founder and CSO of Rubicon Genomics. "MethylPlex is the key to unlocking this diagnostic potential because it produces high resolution maps of methylation for more than 10,000 genes in one day for less than $.10 per gene. This reduces the time and cost to discover and validate new markers by nearly 100- fold."
MethylPlex microarray profiling of genome methylation is as simple and inexpensive as the profiling of gene expression. Key markers for detecting two initial types of cancer, prostate and esophageal, will be determined by analyzing the methylation patterns from hundreds of patients.
Hospitals and reference laboratories will use inexpensive, non-invasive MethylPlex diagnostic tests. The first commercial tests will use serum or urine from patients with high PSA or other indications of prostate cancer to identify those cases that should be treated aggressively, preventing patients from having to undergo periodic biopsies or unnecessary surgeries.
In 2005 Rubicon will determine the specificity and sensitivity of the prostate test by using regulatory-grade clinical samples in preparation for an FDA filing. The automated MethylPlex tests will be inexpensive enough for primary diagnosis and frequent monitoring of disease progression.
MethylPlex has equal potential for diagnosis of other types of cancer.
Rubicon has discovered almost 1,000 new methylation sites associated with cancer; more than double the number discovered by other technologies in the past 10 years.