# US 11,079,384 B2 · Biomarkers and methods for diagnosis of early stage pancreatic ductal adenocarcinoma

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- Number: US 11,079,384 B2
- Document ID: US11079384B2
- Status: Granted
- Kind: B2
- Application number: 16/658,937
- Filed: 2019-10-21
- Published: 2020-03-19
- Granted: 2021-08-03
- Earliest claimed: 2014-05-07
- Assignees: University of Utah Research Foundation
- Applicants: University of Utah Research Foundation
- Inventors: Sean J. Mulvihill; Matthew A. Firpo
- Web page: https://patentgrep.com/patent/US11079384B2

## CPC

- G01N 33/57525: of the liver or pancreas
- G01N 33/57585: {involving compounds identifiable in body fluids}
- C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)}
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N 2800/56: Staging of a disease; Further complications associated with the disease
- G01N 2800/60: Complex ways of combining multiple protein biomarkers for diagnosis
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention provides biomarker compositions and methods for the diagnosis and prognosis of PDAC. In a particular embodiment, the invention provides methods and compositions for screening, diagnosis and prognosis of early stage, asymptomatic PDAC.

## Claims

### Claim 1

An array comprising at least two antibodies or antibody fragments attached to a solid support that specifically bind to at least basigin and soluble hyaluronic acid, respectively.

### Claim 2

A method of diagnosing and treating early stage pancreatic ductal adenoncarcinoma (PDAC) in an individual, the method comprising:
obtaining a serum or plasma sample from an individual;
detecting an elevated protein level of basigin and soluble hyaluronic acid (HA) in the serum or plasma sample when compared to a reference sample, thereby diagnosing the individual with early stage PDAC, wherein the detecting of the elevated protein levels of basigin and HA is performed using a capture agent or an immunoassay, wherein said capture agent is selected from the group consisting of and antibody, antibody fragment, nucleic acid-based protein binding reagent, small molecule or variant thereof, wherein said immunoassay is an enzyme immunoassay (EIA), an enzyme-linked immunosorbent assay (ELISA), or a radioimmunoassay (RIA); and
administering a therapy selected from the group consisting of prophylactic anticoagulants, resection, neoadjuvant chemotherapy, and chemoradiation to the individual with early stage PDAC.

### Claim 3 (depends on 2)

The method of claim 2, further comprising detecting an elevated protein level of one or more of the biomarkers listed in Tables 1 through 4.

### Claim 4 (depends on 3)

The method of claim 3, further comprising calculating the probability for early stage PDAC in said individual based on the elevated protein level of one or more of the biomarkers listed in Tables 1 through 4.

### Claim 5 (depends on 1)

The array of claim 1, further comprising one or more isolated antibodies or antibody fragments attached to the solid support that specifically bind to ALCAM, ANG, AXL, BAG3, CA 19-9, CEA, CEACAM1, COL18A1, EPCAM, HP, ICAM1, IGFBP2, IGFBP4, LCN2, LRG1, MMP2, MMP7, MMP9, MSLN, PARK7, PPBP, PRG4, SPARCL1, SPP1, TGFBI, THBS1, TIMP1, TNFRSF1A, or VEGFC.

### Claim 6 (depends on 2)

The method of claim 2, further comprising detecting an elevated protein level of one or more of ALCAM, ANG, AXL, BAG3, CA 19-9, CEA, CEACAM1, COL18A1, EPCAM, HP, ICAM1, IGFBP2, IGFBP4, LCN2, LRG1, MMP2, MMP7, MMP9, MSLN, PARK7, PPBP, PRG4, SPARCL1, SPP1, TGFBI, THBS1, TIMP1, TNFRSF1A, and VEGFC.

### Claim 7 (depends on 1)

The array of claim 1, wherein the at least two isolated antibodies or antibody fragments are labeled.

### Claim 8 (depends on 5)

The array of claim 5, wherein one or more of the isolated antibodies or antibody fragments attached to the solid support are labeled.