# US 9,518,990 B2 · Secernin-1 as a marker for cancer

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- Number: US 9,518,990 B2
- Document ID: US9518990B2
- Status: Granted
- Kind: B2
- Application number: 13/272,399
- Filed: 2011-10-13
- Published: 2012-02-02
- Granted: 2016-12-13
- Earliest claimed: 2009-05-29
- Assignees: Roche Diagnostics Operations, Inc.
- Applicants: Norbert Wild; Marie-Luise Hagmann; Johann Karl; Julia Riedlinger; Markus Roessler; Michael Tacke
- Inventors: Norbert Wild; Marie-Luise Hagmann; Johann Karl; Julia Riedlinger; Markus Roessler; Michael Tacke
- Web page: https://patentgrep.com/patent/US9518990B2

## CPC

- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Disclosed is a method aiding in the assessment of cancer. It involves the use of the secernin-1 protein (SCRN1) as a universal marker of different cancer types. More specifically disclosed is a method for assessing cancer from a liquid sample derived from an individual by measuring SCRN1 in the sample. Measurement of SCRN1 can, e.g., be used in the early detection of cancer or in the surveillance of patients who undergo surgery.

## Claims

### Claim 1

A method for in vitro assessment of a presence of cancer selected from the group consisting of lung, ovary, endometrial, melanoma, breast, head and neck, bladder, pancreas, cervix, kidney, and prostate cancer in a patient suspected of having cancer selected from the group consisting of lung, ovary, endometrial, melanoma, breast, head and neck, bladder, pancreas, cervix, kidney and prostate cancer, the method comprising
a) detecting a full-length secernin-1 protein (SCRN1) in a body fluid sample from the patient by contacting, in vitro, the body fluid sample with an antibody that specifically binds to an epitope located in amino acids 398-413 of SEQ ID NO:1, wherein the antibody and the full-length SCRN1 form a complex;
b) quantifying a signal from the complex to obtain a concentration of the full-length SCRN1 in the complex;
c) analyzing the concentration of the full-length SCRN1 obtained in said step of quantifying to a SCRN1 reference concentration obtained from a normal control; and
d) providing a diagnosis of the presence of cancer selected from the group consisting of lung, ovary, endometrium, melanoma, breast, head and neck, bladder, pancreas, cervix, kidney, and prostate cancer if the concentration of the full-length SCRN1 obtained in said step of quantifying is greater than the SCRN1 reference concentration obtained from the normal control.

### Claim 2 (depends on 1)

The method according to claim 1, further comprising:
detecting in a body fluid sample from the patient a marker selected from the group consisting of carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), carbohydrate antigen 19-9 (CA 19-9), carbohydrate antigen 125 (CA 125), prostate specific antigen (PSA), pro-gastrin releasing peptide (proGRP), squamous cell carcinoma antigen (SCC), nicotinamide N-methyltransferase (NNMT), anti-p53 autoantibodies, seprase, and soluble dipeptidyl peptidase IV/seprase complex (DPPIV/seprase complex) by contacting, in vitro, the body fluid sample with a second antibody that specifically binds to the marker, wherein the second antibody and the marker form a complex;
b) quantifying a signal from the complex to obtain a concentration of the marker in the complex;
c) analyzing the concentration of the marker obtained in said step of quantifying to a marker reference concentration obtained from a normal control; and
d) providing a diagnosis of presence of cancer if the concentration of the marker obtained in said step of quantifying is greater than the marker reference concentration obtained from the normal control.

### Claim 3 (depends on 1)

A kit for performing the method according to claim 1 comprising reagents for detecting a concentration of SCRN1, wherein at least one reagent is an antibody that specifically binds to an epitope located in amino acids 398-413 of SEQ ID NO:1.

### Claim 4 (depends on 2)

A kit for performing the method according to claim 2 comprising reagents for detecting a concentration of SCRN1, wherein at least one reagent is an antibody that specifically binds to an epitope located in amino acids 398-413 of SEQ ID NO:1 and reagents for detecting a concentration of the marker.
