Patent ID: 7655408

Claim:
A method of determining the malignancy status of prostate cells contained in a sample undergoing testing, said method comprising: (a) amplifying a first PCA3 nucleic acid across nucleotide positions 26 and 255 of SEQ ID NO:1 and a second PCA3 nucleic acid across nucleotide positions 26 and 27 of SEQ ID NO:2 from mRNAs obtained from prostate cells contained in said sample if such first and/or second nucleic acids are present, whereby said first and second PCA3 nucleic acids are synthesized in relative abundance dependent on the malignant and non-malignant status of the prostate cells, wherein the amplification of said first PCA3 nucleic acid results from amplification of a first PCA3 mRNA 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 wherein the amplification of said second PCA3 nucleic acid results from amplification of a second PCA3 mRNA that comprises PCA3 exon 3 joined to PCA3 exon 4a without including said additional sequence; and (b) i) determining a malignant status of the prostate cells in said sample by detecting a higher level of said second PCA3 nucleic acid as compared to said first PCA3 nucleic acid; or ii) determining a non-malignant status of the prostate cells in said sample by detecting a higher level of said first PCA3 nucleic acid as compared to said second nucleic acid; thereby determining the malignancy status of said prostate cells in said sample.