Patent ID: 9416410
Filing Date: 2016-08-16
CPC Classification: A61F,A61L,C12Q,G16B

Claim Text:
1. A streamlined and standardized method for determining the HER2 status of a tumor sample by measuring HER2 mRNA expression level using quantitative real-time PCR technique a simplified scoring system without use of reference genes, and comprising the steps of: (a) preparing a specimen sample with invasive cancer content for HER2 test; (b) extracting total RNA from the specimen sample and measuring its concentration; (c) running reverse transcription and PCR with a constant amount of total RNA for cDNA input along with synthetic oligos (sDNA) as a reference material having at least one embedded cutoff reference point (CRP) and without using a reference gene and wherein the CRP is defined in terms of a specify copy number of HER2 mRNA; and (d) analyzing the mRNA output of the PCR analysis by applying the dynamic and normalized cutoff reference point reading to score the result as HER2 positive or HER2 negative.