Onconome Inc. has developed a blood test which, in numerous studies involving more than 1,000 samples, has demonstrated the ability to accurately determine an individual's probability of having colorectal cancer (CRC).
In our recently completed 2014 prospective study, 457 clinical samples yielded a sensitivity of 100% (n=2), specificity of 86.8% (n=212) to non-CRC normal samples and specificity to histologically negative polyp samples of 88.0% (n=243) and a negative predictive value (NPV) of 100% for the assay. Both the 2012 and the 2014 studies demonstrate that our ONC107 assay is a sensitive and specific, non-invasive test to provide both clinicians and their patients with an understanding of the patients’ probability of having CRC.
CRC is highly curable when diagnosed at an early stage. However, for a variety of reasons, over 40% of adults over 50 either fail or refuse to undergo a colonoscopy. Thus, many at-risk patients really have no idea of their own probability of having CRC. ONC107 would provide that assessment and thereby also provide individuals and their physicians with information upon which to base a decision to either have or defer a colonoscopy or sigmoidoscopy. The Company believes that a serum test which has comparable or better performance characteristics to the iFOBT or any other fecal test will be preferred by patients and that compliance with CRC testing recommendations will thereby be improved.