IP Library Granted Patent US 12,595,516
Granted Patent B2
US 12,595,516 · App. 18/063,257 · Granted Apr 7, 2026

Neuroendocrine tumors

Inventors: Catherine A. Schnabel (San Diego, CA); Yi Zhang (San Diego, CA); Mark G. Erlander (San Diego, CA)
Assignee: Biotheranostics, Inc.
C12Q1/6886C12Q2600/112C12Q2600/158C12Q2600/16
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Quick Facts
Patent No.
US 12,595,516
App. No.
18/063,257
Granted
Apr 7, 2026
Kind
B2
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 (10)

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.

2 . 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.

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

4 . 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.

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

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

7 . 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.

8 . 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.

Assignments (5)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 065286/0407 Recorded Apr 24, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE PRODESSE, INC.
Reel/Frame 075457/0767 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
CHANGE OF ADDRESS Recorded Jun 24, 2024
From: BIOTHERANOSTICS, INC.
To: BIOTHERANOSTICS, INC.
Reel/Frame 067824/0243 →
SECURITY INTEREST Recorded Oct 19, 2023
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 065286/0407 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2022
From: SCHNABEL, CATHERINE; ZHANG, YI; ERLANDER, MARK
To: BIOTHERANOSTICS INC
Reel/Frame 062027/0303 →
Continuity (3)
Division 15656998 · Jul 21, 2017
Continuation 14223473 · Mar 24, 2014
Related Publication 20230287511A1 · Sep 14, 2023
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