# US 12,595,516 B2 · Neuroendocrine tumors

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- Number: US 12,595,516 B2
- Document ID: US12595516B2
- Status: Granted
- Kind: B2
- Application number: 18/063,257
- Filed: 2022-12-08
- Published: 2023-09-14
- Granted: 2026-04-07
- Earliest claimed: 2014-03-24
- Assignees: Biotheranostics, Inc.
- Applicants: Biotheranostics, Inc.
- Inventors: Catherine A. Schnabel; Yi Zhang; Mark G. Erlander
- Web page: https://patentgrep.com/patent/US12595516B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/158: Expression markers
- C12Q 2600/16: Primer sets for multiplex assays
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

The disclosure provides methods for the use of gene expression measurements to classify or identify neuroendocrine cancer in samples obtained from a subject in a clinical setting, such as in cases of formalin fixed, paraffin embedded (FFPE) samples.

## Claims

### Claim 1

A kit comprising (i) a reverse transcriptase and (ii) probes, primers, or both probes and primers for a gene panel, wherein the gene panel is for classifying a sample as containing pancreatic neuroendocrine tumor cells and wherein the gene panel is a four-gene panel consisting of ELAVL4, CADPS, RGS17, and KCNJ11;
wherein the probes, primers, or both probes and primers for the four-gene panel consist of: one or more probes, primers, or both probes and primers that are complementary to a portion of an ELAVL4 cDNA sequence and are labeled with a fluorescent molecule; one or more probes, primers, or both probes and primers that are complementary to a portion of an CADPS cDNA sequence and are labeled with a fluorescent molecule, one or more probes, primers, or both probes and primers that are complementary to a portion of an RGS17 cDNA sequence and are labeled with a fluorescent molecule; and one or more fourth probes, primers, or both probes and primers that are complementary to a portion of an KCNJ11 cDNA sequence and are labeled with a fluorescent molecule,
wherein the kit does not comprise probes, primers, or both probes or primers for genes other than ELAVL4, CADPS, RGS17, and KCNJ11.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the probes, primers, or both probes and primers for the four-gene panel are immobilized on an array or another solid support device or are immobilized in individual spots that localize the probes, primers, or both probes and primers.

### Claim 3 (depends on 1)

The kit of claim 1, further comprising one or more reagents for linear RNA amplification.

### Claim 4 (depends on 1)

The kit of claim 1, further comprising one or more additional reagents for quantitative PCR, real-time PCR, real-time quantitative PCR, or reverse transcription PCR.

### Claim 5 (depends on 1)

The kit of claim 1, further comprising one or more reagents for an RNAse protection assay, liquid phase hybridization, or in situ hybridization.

### Claim 6 (depends on 1)

The kit of claim 1, further comprising one or more enzymes for quantitative PCR amplification.

### Claim 7 (depends on 1)

The kit of claim 1, wherein the kit further comprises data on expression levels of ELAVL4, CADPS, RGS17 and KCNJ11 from a known reference specimen.

### Claim 8 (depends on 1)

The kit of claim 1, wherein the kit further comprises directions for performing a method for classifying the sample as containing pancreatic neuroendocrine tumor cells.