Abstract: Provided is a kinetic PCR (“kPCR”) assay for determining gene copy number of a target gene located on chromosome 17. The kPCR assay uses the MMP-28 gene located at the 17q11.2-17q12 loci as a control and thus, is capable of detecting gene copy number of any gene on chromosome 17 in both singleplex and multiplex format without the need for a standard curve. The kPCR assay is useful for determining the gene copy number of the HER2/neu gene located at loci 17q12-17q21.32, which is a requirement for determining if a breast cancer patient is a candidate for anti-HER2/neu gene therapy.

Abstract: Methods are provided for highly sensitive and rapid in situ detection of a nucleic acid analyte of a known sequence. The method employs oligonucleotide probes in a series of optimized steps to amplify a signal and decrease background. Sensitivity is enhanced such that the method can detect as few as 1–2 copies of nucleic acid analyte per sample, the sample containing a cell, tissue or similar biological material. Methods of detecting and identifying the position of the nucleic acid analyte in a cell are also provided.

Abstract: Methods are provided for highly sensitive and rapid in situ detection of a nucleic acid analyte of a known sequence. The method employs oligonucleotide probes in a series of optimized steps to amplify a signal and decrease background. Sensitivity is enhanced such that the method can detect as few as 1-2 copies of nucleic acid analyte per sample, the sample containing a cell, tissue or similar biological material. Methods of detecting and identifying the position of the nucleic acid analyte in a cell are also provided.