SBIR-STTR Award

Direct to Phase II

The goal of the research is to develop a highly accurate automated and low cost ctDNA test to monitor efficacy of treatment of metastatic breast cancer patients by identifying the emergence of certain DNA mutations in plasma samples. There is growing evidence that the presence of certain DNA mutations in the blood stream correlates with breast cancer becoming resistance to hormone treatment NVIGEN will develop a test that can detect the emergence of these DNA mutations early enough so that Physicians can prescribe a more effective treatment to improve patient outcome. The test involves capturing DNA from the plasma portion of blood samples using NVIGEN s proprietary molecularly engineered magnetic nano particles combined with highly sensitive target enrichment of specific DNA mutation in an automated workflow. During the proposed program NVIGEN will optimize the workflow confirm the test s ability to detect multiple relevant DNA mutations and conduct clinical validations to verify that the DNA mutations detected by the test correlate with efficacy of treatment providing a basis for physicians to select more effective treatments for breast cancer patients. This test will not only help breast cancer patients but the technology can also be extended for a broad range of other cancer types