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.