SBIR Phase II: Enrichment of Cancer DNA for Improved Cancer Diagnostics from Blood

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to diagnose cancer earlier, in particular, residual cancer from a simple blood draw. Each year over 2 million people are diagnosed with cancer in the US. Many people still have residual cancer after completing cancer treatment. The current standard of care is very poor at diagnosing residual cancer, often times the residual cancer is not detected until it is too late to cure. Additionally, 7% of cancer patients have debilitating fear of residual cancer. Diagnosing people with residual cancer earlier will save many lives by treating the residual cancer before it spreads and can no longer be treated to cure. This method has the potential to improve cancer diagnosis, improve cancer treatments, and improve patient outcomes by providing a better method for diagnosing cancer, which is highly sensitive and highly accurate. This Small Business Innovation Research (SBIR) Phase II project will improve and validate the method is effective at diagnosing cancer from a blood draw with patient samples. A cancer test needs to be highly accurate because cancer treatment is often very toxic. A cancer test also needs to detect cancer very early because that is when cancer is most curable. Creating a cancer test, which can do both, is very difficult. Cancer DNA in blood is very rare, as vast majority of the DNA in blood is from normal cells. This method turns a needle (cancer DNA) in a haystack (normal DNA) into a mountain of needles by blocking the normal DNA from replicating in a tube. This increases the percentage of cancer DNA, making it very easy to determine which samples have cancer DNA and which samples do not. This project will optimize the current method, verify the method can easily be done in a commercial setting, and validate the method works with real patient samples. The anticipated result is a simple blood draw that can accurately detect a single copy of ca