Patent ID: 8241848

Claim:
A method of determining the malignancy status of prostate cells contained in a sample undergoing testing, said method comprising: (a) performing a hybridization and/or amplification reaction to assess, from PCA3 RNAs from prostate cells contained in said sample or from cDNAs derived therefrom, whether said PCA3 RNAs or cDNAs comprise or lack 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 (b) determining, based on the presence or level of a PCA3 nucleic acid molecule comprising or lacking said additional sequence, that said prostate cells are: (i) non-malignant when said PCA3 nucleic acid molecule comprises said additional sequence; or (ii) malignant when said PCA3 nucleic acid molecule lacks said additional sequence and comprises nucleotide positions 26 and 27 of SEQ ID NO: 2, which define the PCA3 exon 3-exon 4a junction.