A Diagnostics & Imaging Week
Source MDx (Boulder, Colorado) reported being awarded a Small Business Innovation Research grant by the National Institutes of Health (Bethesda, Maryland) to develop a molecular diagnostic test that will characterize hepatitis C- (HCV) infected patients and their response to standard-of-care therapy.
The amount of the grant was not disclosed.
Source MDx said it is able to analyze biomarkers from various samples. including a blood sample, which is less invasive than many current clinical tests, such as liver biopsy.
"Although HCV targets the liver, sampling of whole blood is relatively non-invasive and peripheral blood is representative of many systemic processes," said Lisa Siconolfi, PhD, director of clinical studies at Source MDx. "Changes in gene expression in the blood from HCV patients could yield important foundational information for the development of a patient care diagnostic in the area of infectious diseases."
The company said that the development of clinically useful RNA-based biomarkers has been inhibited by the inability to measure gene expression with sufficient precision, as well as the presumption that gene expression is too variable within and between individuals.
Source MDx says it has addressed the issues of precision measurement (U.S. patent No. 6,692,916) and has established a normal range of human gene expression (U.S. patent No. 6,960,439), as the foundation for the use of RNA-based molecular diagnostics to monitor an individual's health, disease status and response to therapy.