Multi-protein classifier for detecting early-stage ovarian cancer
OwnerAmy Patrice Skubitz, Kristin L.M. Boylan +2inventors
InventorsAmy Patrice Skubitz, Kristin L.M. Boylan, Ashley Jenna Petersen, Timothy Kaehler Starr
Life of this patent
Estimating the term…
Abstract
In one aspect, the present disclosure relates to a method for determining risk of ovarian cancer in a patient, the method including: providing a biological sample from the patient; measuring a level of CA1225 in the biological sample; measuring a level of SEZ6L in the biological sample; and identifying that the patient is at risk of ovarian cancer based on the level of CA125 and the level of SEZ6L. In one or more embodiments, the method further includes measuring a level of HE4 and ITGAV. In another aspect, the present disclosure relates to a kit, system, or computer program for performing a method described herein.
Claims20
A method for determining risk of ovarian cancer in a patient, the method comprising:
- providing a biological sample from the patient;
- measuring a level of mucin 16 (CA125) in the biological sample;
- measuring a level of seizure 6-like protein (SEZ6L) in the biological sample;
- and
- identifying that the patient is at risk of ovarian cancer based on the level of CA125 and the level of SEZ6L.
A method for determining an ovarian cancer risk score in a patient comprising:
- providing a biological sample;
- measuring a level of CA125 protein, a level of HE4 protein, a level of ITGAV protein, and a level of SEZ6L protein in the biological sample;
- providing levels of CA125 protein, HE4 protein, ITGAV protein, and SEZ6L protein from at least one reference sample;
- determining, for each protein, a difference in the level of protein in the biological sample and the reference sample, thereby providing a normalized level of each protein;
- weighting the normalized level of CA125 using a first coefficient a, wherein a is a positive value;
- weighting the normalized level of H1 using a second coefficient b, wherein b is a positive value;
- weighting the normalized level of ITGAV using a third coefficient c, wherein c is a negative value;
- weighting the normalized level of SEZ6L using a fourth coefficient d, wherein d is a negative value;
- determining an intercept value X;
- and
- determining an ovarian cancer risk score for the patient, wherein the ovarian cancer risk score is calculated using Formula II:
- Risk
-
- score
-
- %
- =
- 100
- *
- (
- e
- X
- +
- a
-
- (
- CA
-
- 125
- )
- +
- b
-
- (
- HE
-
- 4
- )
- +
- c
-
- (
- ITGAV
- )
- +
- d
-
- (
- SEZ
-
- 6
-
- L
- )
- 1
- +
- e
- X
- +
- a
-
- (
- CA
-
- 125
- )
- +
- b
-
- (
- HE
-
- 4
- )
- +
- c
-
- (
- ITGAV
- )
- +
- d
-
- (
- SEZ
-
- 6
-
- L
- )
- )
- Formula
-
- II
- wherein the ovarian cancer risk score indicates a percent chance the patient has ovarian cancer.
A kit comprising:
- a first reagent to measure a level of CA125 protein in a biological sample, the first reagent comprising an antibody and an oligonucleotide;
- a second reagent to measure a level of HE4 protein in a biological sample, the second reagent comprising an antibody and an oligonucleotide;
- a third reagent to measure a level of ITGAV protein in a biological sample, the third reagent comprising an antibody and an oligonucleotide;
- a fourth reagent to measure a level of SEZ6L protein in a biological sample, the fourth reagent comprising an antibody and an oligonucleotide;
- and
- a plate comprising wells, wherein a first well comprises the first reagent, a second well comprises the second reagent, a third well comprises the third reagent, and a fourth well comprises the fourth reagent.
A computer program comprising a non-transitory computer readable medium on which is provided program instructions for steps of
- providing levels of CA125 protein HE4 protein, ITGAV protein, and SEZ6L protein from a biological sample from a patient;
- providing levels of CA125 protein, HE4 protein, ITGAV protein, and SEZ6L protein from at least one reference sample;
- determining, for each protein, a difference in the level of protein in the biological sample and the reference sample, thereby providing a normalized level of each protein;
- weighting the normalized level of CA125 using a first coefficient a, wherein a is a positive value;
- weighting the normalized level of HE4 using a second coefficient b, wherein b is a positive value;
- weighting the normalized level of ITGAV using a third coefficient c, wherein c is a negative value;
- weighting the normalized level of SEZ6L, using a fourth coefficient d, wherein d is a negative value;
- determining an intercept value X;
- and
- determining an ovarian cancer risk score for the patient, wherein the ovarian cancer risk score is calculated using Formula II:
- Risk
-
- score
-
- %
- =
- 100
- *
- (
- e
- X
- +
- a
-
- (
- CA
-
- 125
- )
- +
- b
-
- (
- HE
-
- 4
- )
- +
- c
-
- (
- ITGAV
- )
- +
- d
-
- (
- SEZ
-
- 6
-
- L
- )
- 1
- +
- e
- X
- +
- a
-
- (
- CA
-
- 125
- )
- +
- b
-
- (
- HE
-
- 4
- )
- +
- c
-
- (
- ITGAV
- )
- +
- d
-
- (
- SEZ
-
- 6
-
- L
- )
- )
- Formula
-
- II
- wherein the ovarian cancer risk score indicates a percent chance the patient has ovarian cancer.
Dependencies are inferred from the claim text.