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.
