This invention relates to detection of specific extracellular nucleic acid
in plasma or serum fractions of human or animal blood associated with
neoplastic or proliferative disease. Specifically, the invention relates
to detection of nucleic acid derived from mutant oncogenes or other
tumor-associated DNA, and to those methods of detecting and monitoring
extracellular mutant oncogenes or tumor-associated DNA found in the
plasma or serum fraction of blood by using rapid DNA extraction followed
by nucleic acid-amplification with or without enrichment for mutant DNA.
In particular, the invention relates to the detection, identification, or
monitoring of the existence, progression or clinical status of benign,
premalignant, or malignant neoplasms in humans or other animals that
contain a mutation that is associated with the neoplasm through detection
of the mutated nucleic acid of the neoplasm in plasma or serum fractions.
The invention permits the detection of extracellular, tumor-associated
nucleic acid in the serum or plasma of humans or other animals recognized
as having a neoplastic or proliferative disease or in individuals without
any prior history or diagnosis of neoplastic or proliferative disease.
The invention provides the ability to detect extracellular nucleic acid
derived from genetic sequences known to be associated with neoplasia,
such as oncogenes, as well as genetic sequences previously unrecognized
as being associated with neoplastic or proliferative disease. The
invention thereby provides methods for early identification of
colorectal, pancreatic, lung, breast, bladder, ovarian, lymphoma and all
other malignancies carrying tumor-related mutations of DNA and methods
for monitoring cancer and other neoplastic disorders in humans and other
animals.