IP Library Granted Patent US 9,341,628
Granted Patent B2
US 9,341,628 · App. 14/092,036 · Granted May 17, 2016

Methods for measuring carcinoembryonic antigen

Inventors: Sydney David Finkelstein (Pittsburgh, PA); Sara Ann Jackson (Pittsburgh, PA); Jamie Michelle Bleicher (Butler, PA); Eric Matthew Gayle Ellsworth (Pittsburgh, PA); Dennis Morgan Smith, Jr. (St. Augustine, FL)
Assignee: INTERPACE DIAGNOSTICS CORPORATION
G01N33/57473
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Quick Facts
Patent No.
US 9,341,628
App. No.
14/092,036
Granted
May 17, 2016
Kind
B2
Abstract

Disclosed herein are methods of accurately measuring carcinoembryonic antigen in a biological sample and methods of identifying and treating a mucinous cyst in a subject.

Claims (20)

1. A method of measuring carcinoembryonic antigen in a biological sample, the method comprising:

diluting the biological sample with a diluent at a ratio of biological sample to diluent of about 1:10 to about 1:50 to form a diluted biological sample;

measuring the amylase level of the diluted biological sample;

measuring carcinoembryonic antigen level in the diluted biological sample; and multiplying the carcinoembryonic antigen level by a correction factor to obtain a corrected carcinoembryonic antigen level when the amylase level in the diluted samples is above about 10,000 units.

2. The method of claim 1 , wherein the diluent is saline, Diluent Universal, or a combination thereof.

3. The method of claim 1 , wherein the biological sample is undiluted prior to the diluting step.

4. The method of claim 1 , wherein diluting the biological sample with a diluent comprises diluting the biological sample with a diluent in a ratio of about 1:10.

5. The method of claim 1 , wherein diluting the biological sample with a diluent comprises diluting the biological sample with a diluent in a ratio of about 1:40.

6. The method of claim 1 , wherein the correction factor is about 0.7.

7. The method of claim 1 , wherein the biological sample is not present in sufficient volume to accurately measure carcinoembryonic antigen level.

8. The method of claim 1 , wherein the biological sample has a high viscosity.

9. The method of claim 8 , wherein the high viscosity is due to the presence of mucin in the biological sample.

10. The method of claim 1 , wherein the carcinoembryonic antigen levels in the biological sample exceed the measurement capabilities of an instrument being used to measure carcinoembryonic antigen level.

11. The method of claim 1 , wherein the biological sample is selected from pancreatic fluid, pancreatic cyst fluid and combinations thereof.

12. The method of claim 1 , wherein a corrected carcinoembryonic antigen level above a predetermined carcinoembryonic antigen threshold is indicative of a pathological condition.

13. The method of claim 12 , wherein the carcinoembryonic antigen level threshold is about 192 ng/ml or about 400 ng/ml.

14. The method of claim 12 , wherein the pathological condition is a neoplastic condition or a non-neoplastic condition.

15. The method of claim 14 , wherein the neoplastic condition is selected from colorectal carcinoma, gastric carcinoma, cholangiocarcinoma, pancreatic carcinoma, intraductal papillary mucinous neoplasm (IPMN), lung carcinoma, breast carcinoma, medullary thyroid carcinoma, and combinations thereof.

16. The method of claim 14 , wherein the non-neoplastic condition is selected from ulcerative colitis, pancreatitis, pancreatic cysts, pancreatic masses, biliary strictures, cirrhosis, chronic obstructive pulmonary disease, Crohn's disease, intraductal papillary mucinous neoplasm (IPMN), and combinations thereof.

17. The method of claim 1 , wherein the carcinoembryonic antigen level is multiplied by a correction factor to obtain a corrected carcinoembryonic antigen level when the amylase level in the diluted sample is above about 20,000 units.

Assignments (11)
SECURITY INTEREST Recorded Nov 2, 2021
From: INTERPACE BIOSCIENCES, INC.; INTERPACE DIAGNOSTICS CORPORATION; INTERPACE DIAGNOSTICS, LLC; INTERPACE PHARMA SOLUTIONS, INC.
To: BROADOAK FUND V, L.P.
Reel/Frame 057988/0110 →
SECURITY INTEREST Recorded Oct 20, 2021
From: INTERPACE DIAGNOSTICS CORPORATION
To: COMERICA BANK
Reel/Frame 057851/0289 →
SECURITY INTEREST Recorded Mar 27, 2017
From: INTERPACE DIAGNOSTICS GROUP, INC.
To: HUDSON BAY MASTER FUND LTD
Reel/Frame 041754/0517 →
GUARANTEE AND COLLATERAL AGREEMENT Recorded Sep 23, 2016
From: PDI, INC.; GROUP DCA, LLC; INTERPACE BIOPHARMA, LLC; INTERPACE DIAGNOSTICS, LLC; JS GENETICS, INC.; REDPATH ACQUISITION SUB, INC.
To: REDPATH EQUITYHOLDER REPRESENTATIVE, LLC
Reel/Frame 040125/0251 →
JOINDER TO GUARANTEE AND COLLATERAL ASSIGNMENT Recorded Sep 23, 2016
From: INTERPACE DIAGNOSTICS CORPORATION; PDI, INC.; GROUP DCA, LLC; INTERPACE BIOPHARMA, LLC; INTERPACE DIAGNOSTICS, LLC; JS GENETICS, INC.
To: REDPATH EQUITYHOLDER REPRESENTATIVE, LLC
Reel/Frame 040127/0018 →
RELEASE OF SECURITY INTEREST Recorded Feb 22, 2016
From: SWK FUNDING LLC
To: INTERPACE DIAGNOSTICS CORPORATION
Reel/Frame 037783/0678 →
SECURITY INTEREST Recorded Nov 18, 2014
From: INTERPACE DIAGNOSTICS CORPORATION
To: SWK FUNDING LLC, AS AGENT
Reel/Frame 034202/0192 →
SECURITY INTEREST Recorded Nov 10, 2014
From: INTERSPACE DIAGNOSTICS CORPORATION
To: REDPATH EQUITYHOLDER REPRESENTATIVE, LLC
Reel/Frame 034136/0312 →
MERGER AND CHANGE OF NAME Recorded Nov 6, 2014
From: REDPATH INTEGRATED PATHOLOGY, INC.; REDPATH ACQUISITION SUB, INC.; INTERPACE DIAGNOSTICS CORPORATION
To: INTERPACE DIAGNOSTICS CORPORATION
Reel/Frame 034114/0658 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 6, 2014
From: FINKELSTEIN, SYDNEY DAVID; JACKSON, SARA ANN; BLEICHER, JAMIE MICHELLE; ELLSWORTH, ERIC MATTHEW GAYLE; SMITH, DENNIS MORGAN, JR.
To: REDPATH INTEGRATED PATHOLOGY, INC.
Reel/Frame 034118/0136 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 2, 2014
From: FINKELSTEIN, SYDNEY DAVID; JACKSON, SARA ANN; BLEICHER, JAMIE MICHELLE; ELLSWORTH, ERIC MATTHEW GAYLE; SMITH, DENNIS MORGAN, JR.
To: REDPATH INTEGRATED PATHOLOGY, INC.
Reel/Frame 031875/0596 →
Continuity (4)
Provisional Application 61731725 · Nov 30, 2012
Provisional Application 61824623 · May 17, 2013
Provisional Application 61840963 · Jun 28, 2013
Related Publication 20140154698A1 · Jun 5, 2014