Patent ID: 7927806

Claim:
A method of determining the malignancy status of prostate cells contained in a sample undergoing testing, said method comprising: (a) amplifying PCA3 nucleic acids using RNA templates and a pair of oligonucleotides which amplify across nucleotide positions 26 and 255 of SEQ ID NO:1 and across nucleotide positions 26 and 27 of SEQ ID NO:2, thereby resulting in a collection of amplified nucleic acids, when said PCA3 nucleic acids are present, said collection comprising (i) a PCA3 nucleic acid that comprises an additional sequence between PCA3 exon 3 and PCA3 exon 4a, said additional sequence consisting essentially of nucleotides 27 to 254 of SEQ ID NO:1; and (ii) a PCA3 nucleic acid that comprises PCA3 exon 3 joined to PCA3 exon 4a without including said additional sequence; and (b) detecting among said collection of amplified nucleic acids (iii) substantially only said PCA3 nucleic acid that comprises PCA3 exon 3 joined to PCA3 exon 4a without including said additional sequence, and not said PCA3 nucleic acid that comprises said additional sequence, if said sample comprises prostate cancer cells; and (iv) substantially only said PCA3 nucleic acid that comprises said additional sequence between PCA3 exon 3 and PCA3 exon 4a, and not said PCA3 nucleic acid that comprises PCA3 exon 3 joined to PCA3 exon 4a without including said additional sequence, if prostate cells contained in the sample consist of benign prostate cells associated with BPH, thereby determining the malignancy status of prostate cells contained in said sample.