EP0259183A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Process for controlling the accuracy and precision of sensitivity assays
Assignee: LIFETRAC
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Filing: 1987-09-04
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Granted: —
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Expires: 2007-09-04
Abstract
Abstract A method of determining the relative clinical potency of a test agent, such as a chemotherapeutic drug or radiation, on cells from an individual. A plurality of assay cell samples from the individual are treated with a different doses of the agent, and the growth of the cell samples measured. An "inhibitory value" is then calculated, which is the value of one of the dose and dose response, corresponding to a selected value of the other one. For drug testing, the inhibitory value is preferably the value of the dose which produces a dose response selected at a 90% kill. The inhibitory value can then be compared with inhibitory values for cells from a plurality of other individuals to ascertain the relative clinical potency of the test agent. A number of techniques are provided which reduce errors associated with such assays so that meaningful comparisons can be made.
Inventors
- 👤 Fraser Lee Baker
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-09 06:38
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/5005; G01N33/5008; G01N33/5011
Claims Analysis
Total Claims: 9
Claim 1
Independent Claim
91 words
A process for determining the relative clinical potency of a test agent on cells from an individual, comprising treating a plurality of assay cell samples from the individual with different doses of the agent and measuring the growth of the cell samples, calculating an inhibitory value as the value of one of the dose and growth corresponding to a preselected value of the other one, then comparing the inhibitory value with inhibitory values for cells from a plurality of other individuals to ascertain the relative clinical potency of the test agent.
Claim 2
Dependent Claim
91 words
A process for determining the relative clinical potency of a test agent on cells from an individual, comprising treating a plurality of assay cell samples from the individual with different doses of the agent and measuring the growth of the cell samples, calculating an inhibitory value as the value of one of the dose and growth corresponding to a preselected value of the other one, then comparing the inhibitory value with inhibitory values for cells from a plurality of other individuals to ascertain the relative clinical potency of the test agent.
Claim 3
Dependent Claim
46 words
A process according to claim 1 wherein growth of the cell samples are measured by culturing the samples after exposure to the agent, then measuring their optical density so as to obtain a measure of the growth of cells in each sample which survived the treatment.
Claim 4
Dependent Claim
62 words
A process according to claim 2, additionally comprising treating a background control sample with a toxic agent so as to kill only dividing cells, and culturing it in the same manner as the assay samples, then measuring the optical density and subtracting the resulting value from the measured optical densities of the assay cell samples to obtain corrected optical densities for them.
Claim 5
Dependent Claim
121 words
A process according to claim 2 or claim 3 additionally comprising culturing a plurality of inoculum control samples in the same manner as the assay samples, each having a different initial cell count, then measuring the optical densities of the inoculum control samples and calculating the expected optical density of a particular inoculum control sample which would have the same initial cell count used in the assays based on the best linear relationship of measured optical density versus initial cell count for the inoculum control samples, and rejecting the assay results if the ratio of the calculated to measured optical density of the particular inoculum control sample exceeds a value which would indicate cell overgrowth in the cultured assay cell samples.
Claim 6
Dependent Claim
36 words
A process according to any preceding claim wherein the cell samples are placed in respective chambers, the method additionally comprising incorporating a viscosifier into each cell sample so as to inhibit cell aggregation and redistribution therein.
Claim 7
Dependent Claim
13 words
A process according to any preceding claim wherein the cells are tumor cells.
Claim 8
Dependent Claim
18 words
A process according to any preceding claim wherein the test agent is selected from chemotherapeutic drugs and radiation.
Claim 9
Dependent Claim
80 words
A process according to any one of claims 4 to 7 wherein the test agent is a cytotoxic drug and the cell count of the particular inoculum control sample is the highest of those control samples, and wherein the optical density measurements from the assay cell samples are rejected if the calculated to measured optical density ratio of the particular inoculum control sample exceeds the inverse of a selected survival ratio of the cells following exposure to a test agent.
References Cited (Backward Citations)
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