IP Library Granted Patent US 10,545,151
Granted Patent B2
US 10,545,151 · App. 15/120,502 · Granted Jan 28, 2020

Methods for analyzing rare circulating cells

Inventor: Dena Marrinucci (San Diego, CA)
Assignee: Epic Sciences, Inc.
G01N33/57423C12Q1/6841G01N2333/70589
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Quick Facts
Patent No.
US 10,545,151
App. No.
15/120,502
Granted
Jan 28, 2020
Kind
B2
Abstract

The disclosure provides methods for analyzing rare circulating cells (RCCs) at cellular and molecular level following their detection in non-enriched blood samples, methods of this disclosure serve as diagnostic methods for several disease conditions, including cardiovascular diseases and cancer.

Claims (18)

1. A method for analyzing rare circulating cells (RCCs) in a non-enriched blood sample, comprising: (a) detecting RCCs in the non-enriched blood sample, comprising i) determining presence or absence of one or more immunofluorescent RCC detection markers in nucleated cells in the non-enriched blood sample, and ii) assessing the morphology of the nucleated cells, wherein RCCs are detected among the nucleated cells based on a combination of distinct immunofluorescent staining and morphological characteristics; (b) quenching the immunofluorescence of the one or more immunofluorescent RCC detection markers comprising contacting the RCCs with a quenching buffer, wherein the quenching buffer comprises a chaotropic salt and wherein the immunofluorescence is quenched by more than 50%, 60%, 70%, 80%, 90%, 95%, 99%, 99.9% or 99.99%; and (c) analyzing the detected RCCs, comprising determining presence or absence of one or more fluorescent RCC analysis markers, wherein analyzing the detected RCCs comprises assessing the morphology of the detected RCCs.

2. The method of claim 1 , wherein the fluorescent RCC analysis markers are fluorescence in situ hybridization (FISH) markers.

3. The method of claim 1 , wherein more than 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 99% of RCCs detected in (a) are retained in (c).

4. The method of claim 1 , wherein the fluorescent RCC analysis markers are positive control markers.

5. The method of claim 4 , wherein the positive control markers are present in more than 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95% or 99% of RCCs analyzed in (c).

6. The method of claim 4 , wherein the positive control markers are chromosomal markers.

7. The method of claim 4 , wherein the positive control markers are centromere markers or telomere markers.

8. The method of claim 1 , wherein the RCC analysis markers are genetic mutations selected from the group consisting of gene translocation, gene amplification, gene deletion, gene aneuploidy and chromosomal aneuploidy.

9. The method of claim 1 , wherein the RCCs are circulating tumor cells (CTCs).

10. The method of claim 1 , wherein the RCCs are circulating epithelial cells (CECs).

11. The method of claim 1 , wherein the RCCs are CTC mimics.

12. The method of claim 1 , wherein the RCCs are CTC candidates.

13. The method of claim 1 , wherein the quenching buffer comprises a chaotropic agent.

14. The method of claim 13 , wherein the concentration of the chaotropic agent is at least 2M, 3M or 4M.

15. The method of claim 1 , wherein the quenching buffer comprises guanidine or a guanidinium salt.

16. The method of claim 1 , wherein the quenching buffer comprises guanidinium thiocyanate (guanidine thiocyanate) or guanidinium chloride (guanidine hydrochloride).

17. The method of claim 1 , wherein the RCCs were contacted with the quenching buffer for a period of time of more than 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, 10 minutes, 15 minutes or more than 20 minutes.

18. The method of claim 1 , wherein the analyzed RCCs comprise RCC aggregates.

Assignments (4)
SECURITY INTEREST Recorded Aug 22, 2024
From: EPIC SCIENCES, INC.
To: LABORATORY CORPORATION OF AMERICA HOLDINGS
Reel/Frame 068748/0873 →
RELEASE OF SECURITY INTEREST Recorded Jun 22, 2024
From: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
To: EPIC SCIENCES, INC.
Reel/Frame 067808/0425 →
SECURITY INTEREST Recorded Mar 31, 2021
From: EPIC SCIENCES, INC.
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 055785/0184 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 19, 2019
From: MARRINUCCI, DENA
To: EPIC SCIENCES, INC.
Reel/Frame 049809/0353 →
Continuity (2)
Provisional Application 61943192 · Feb 21, 2014
Related Publication 20170010268A1 · Jan 12, 2017