Methods for determining drug responsiveness
OwnerAlexander Steven Whitehead, Sharon S. Challberg +1inventors
InventorsAlexander Steven Whitehead, Sharon S. Challberg, James G. Lazar
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Abstract
The invention provides a diagnostics assay for measuring the responsiveness to a drug by comparing the mRNA levels of a gene that responds to the drug, such as a steroid, to the mRNA levels of a gene that does not respond to the drug. Methods according to the invention are useful for predicting the ability of a patient (or a tissue, body fluid or cell sample in vitro) to respond to a drug or steroid at any stage of their treatment (i.e., before, during or after), and to monitor the patient (or a tissue, body fluid or cell) over time to assess continued responsiveness to the drug or steroid.
Claims20
A method for determining steroid responsiveness in a subject, comprising
- determining the ratio of gene expression levels of a first gene and a second gene in a clinical sample from said subject and comparing said ratio to a predetermined control ratio,
- wherein said first gene is a steroid responsive gene and said second gene is a steroid non-responsive gene,
- wherein said control ratio is the ratio of gene expression levels of said first gene and said second gene in either a nonresponsive subject or in a responsive subject,
- and wherein said subject is steroid responsive if said ratio is higher than the control ratio for a non-responsive subject or is substantially similar to the control ratio for a responsive subject.
A method for determining steroid responsiveness in a subject undergoing steroid treatment, comprising:
- comparing the expression level ratio of a first gene and a second gene in a clinical sample obtained from said subject prior to steroid administration with the expression level ratio of said first and said second gene in a clinical sample obtained from said subject after administration of a steroid,
- wherein said first gene is a steroid responsive gene and said second gene is a steroid non-responsive gene,
- and wherein a pre-administration ratio that is less than the post-administration ratio is indicative of steroid responsiveness in said subject, and wherein a pre-administration ratio that is greater than or the same as than the post-administration ratio is indicative of steroid non-responsiveness in said subject.
A method for determining steroid responsiveness in a clinical sample, comprising:
- comparing the expression level ratio of a first gene and a second gene in said clinical sample obtained prior to in vitro exposure of said sample to a steroid with the expression level ratio of said first and said second gene in said clinical sample obtained after in vitro exposure of said sample to a steroid,
- wherein said first gene is a steroid responsive gene and said second gene is a steroid non-responsive gene,
- and wherein a pre-exposure ratio that is less than the post-exposure ratio is indicative of steroid responsiveness in said sample, and wherein a pre-exposure ratio that is greater than or the same as than the post-exposure ratio is indicative of steroid non-responsiveness in said sample.
5 The method according to claim 4, wherein said gene expression levels are determined by measuring RNA levels using RT-PCR.
Dependencies are inferred from the claim text.