This invention relates to the use of tumor-derived or associated
extracellular ribonucleic acid (
RNA) found circulating in the
plasma or serum fraction of blood for the detection, monitoring, or evaluation of
cancer or premalignant conditions.
Extracellular RNA may circulate as non-bound
RNA,
protein-bound RNA, lipid-RNA complexes,
lipoprotein (proteolipid)-RNA complexes,
protein-RNA complexes including within or in association with
ribonucleoprotein complexes, nucleosomes, or within apoptotic bodies. Any
intracellular RNA found in
plasma or serum can additionally be detected by this invention. Specifically, this invention enables the extraction of circulating RNA from
plasma or serum and utilizes
nucleic acid amplification assays for the identification, detection,
inference, monitoring, or evaluation of any
neoplasm, benign, premalignant, or malignant, in humans or other animals, which might be associated with that RNA. Further, this invention allows the qualitative or quantitative detection of tumor-derived or associated
extracellular RNA circulating in the plasma or serum of humans or animals with or without any prior knowledge of the presence of
cancer or premalignant tissue.