Amy Meiwah Lo

US Patent:

20210071270, Mar 11, 2021

Filed:

Nov 20, 2020

Appl. No.:

17/100357

Inventors:

- San Francisco CA, US
- Tucson AZ, US
- Tokyo, JP
Amy A. LO - San Francisco CA, US
Takeshi KUWATA - Kashiwa, JP
Akio KAITO - Kashiwa, JP
Atsushi OCHIAI - Kashiwa, JP

International Classification:

C12Q 1/6886
C12Q 1/682
C12Q 1/686

Abstract:

A method for predicting responsiveness to a HER2-directed therapy by assessing HER2 heterogeneity in a tumor includes contacting a sample of the tumor with a biomarker-specific reagent that specifically binds to HER2 protein and detecting HER2 protein in the sample, contacting the sample of the tumor with a first nucleic acid probe that specifically binds HER2 genomic DNA and detecting HER2 gene amplification status in the sample, contacting the sample of the tumor with a second nucleic acid probe that specifically binds HER2 RNA and detecting HER2 RNA status in the sample scoring the HER2 protein (IHC), HER2 gene (DISH), and HER2 RNA (RNA-ISH), predicting that the tumor is responsive to the HER2-directed therapy if the tumor reveals a first foci having a first score and a second score, in which the first score and the second score are not the same.