IP Library Granted Patent US 7,803,624
Granted Patent B2
US 7,803,624 · App. 10/676,568 · Granted Sep 28, 2010

Automated cytological sample classification

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Quick Facts
Patent No.
US 7,803,624
App. No.
10/676,568
Granted
Sep 28, 2010
Kind
B2
Abstract

An automated method for classifying a cytological sample is provided. The method comprises interrogating the sample with one or more wavelengths of light to obtain a result, and then attaching one or more designators to the sample based on whether the result meets a given criterion. The method allows for rapid feedback on the characteristics of the sample, permitting automated designation of the sample as positive for a given characteristic, and allowing for immediate remedial actions if the sample fails to meet the criterion.

Claims (23)

1. An automated method of classifying a cytological sample, comprising:

a) obtaining an initial cytological sample from a patient;

b) providing the initial cytological sample in solution in a vessel;

c) optically interrogating the solution containing the initial sample with at least one wavelength of light;

d) determining, based on the interrogation, whether the solution containing the initial sample has an adequate concentration of cellular material;

e) obtaining an additional cytological sample from the patient to be added to the solution if the solution containing the initial sample does not have an adequate concentration of cellular material;

f) attaching a positive designator to the vessel if the solution containing the initial sample has an adequate concentration of cellular material and is satisfactory for preparing a specimen slide; and

g) attaching a manipulation designator to the vessel if the solution containing the initial sample has an adequate concentration of cellular material but requires a manipulation to render the solution containing the initial sample satisfactory for slide preparation.

2. The method of claim 1 , wherein the cellular material comprises prokaryotic, eukaryotic, or archea type cells.

3. The method of claim 1 , wherein the positive designator indicates that the sample is satisfactory for automated slide preparation.

4. The method of claim 1 , wherein the positive designator further indicates that the solution containing the initial sample is adequate in quantity to allow for withdrawal of a portion of the solution containing the initial sample prior to preparing the specimen slide.

5. The method of claim 1 , wherein the manipulation to render the solution containing the initial sample satisfactory for slide preparation comprises adding acetic acid to the solution containing the initial sample.

6. The method of claim 1 , wherein the manipulation to render the solution containing the initial sample satisfactory for slide preparation comprises adding a reducing agent to the solution containing the initial sample.

7. The method of claim 1 , wherein the cellular material is endocervical cells.

8. The method of claim 1 , wherein the solution containing the initial sample requires a manipulation to render the solution containing the initial sample satisfactory for slide preparation if a level of blood or mucus in the solution containing the initial sample exceeds a threshold level of blood or mucus.

9. The method of claim 1 , wherein the positive designator comprises a physical marking on the vessel.

10. The method of claim 1 , wherein the positive designator comprises a designation in an electronic memory.

11. The method of claim 1 , wherein the manipulation designator comprises a physical marking on the vessel.

12. The method of claim 1 , wherein the manipulation designator comprises a designation in an electronic memory.

13. The method of claim 1 , wherein the initial sample is selected from the group consisting of blood; urine; semen; milk; sputum; mucus; plueral fluid; pelvic fluid; sinovial fluid; ascites fluid; a body cavity wash; eye brushing; skin scrapings; a buccal swab; a vaginal swab; a pap smear; a rectal swab; an aspirate; a needle biopsy; a section of tissue; plasma; serum; spinal fluid; lymph fluid; an external secretion of the skin, respiratory, intestinal, or genitourinary tract; tears; saliva; a tumor; an organ; a microbial culture; and an in vitro cell culture constituent.

14. The method of claim 1 , wherein the solution comprises a water-soluble alcohol in an amount effective to preserve the sterility of the initial sample toward at least one contaminant.

15. The method of claim 1 , wherein steps c) and d) occur in temporal conjunction with steps a) and b).

16. The method of claim 1 , wherein step e) occurs in temporal conjunction with steps a) through d).

Assignments (11)
RELEASE OF SECURITY INTEREST Recorded Apr 28, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC., ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO DIRECT RADIOGRAPHY CORP.; CYTYC CORPORATION, ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO BIOLUCENT, LLC; CYTYC SURGICAL PRODUCTS, LLC, AS SUCCESSOR-BY-CONVERSION TO CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; GEN-PROBE INCORPORATED, ON ITS OWN BEHALF AND AS SUCCESSOR-BY-MERGER TO THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE PRODESSE, INC.; SUROS SURGICAL SYSTEMS, INC.
Reel/Frame 075566/0039 →
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 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT PATENT NO. 8081301 PREVIOUSLY RECORDED AT REEL: 035820 FRAME: 0239. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST RELEASE. Recorded Nov 9, 2017
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
Reel/Frame 044727/0529 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT PATENT NO. 8081301 PREVIOUSLY RECORDED AT REEL: 028810 FRAME: 0745. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Nov 9, 2017
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
To: GOLDMAN SACHS BANK USA
Reel/Frame 044432/0565 →
SECURITY AGREEMENT Recorded Aug 7, 2015
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; DIRECT RADIOGRAPHY CORP.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 036307/0199 →
SECURITY INTEREST RELEASE REEL/FRAME 028810/0745 Recorded Jun 4, 2015
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
Reel/Frame 035820/0239 →
SECURITY AGREEMENT Recorded Aug 1, 2012
From: HOLOGIC, INC.; BIOLUCENT, LLC; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS, LIMITED PARTNERSHIP; SUROS SURGICAL SYSTEMS, INC.; THIRD WAVE TECHNOLOGIES, INC.; GEN-PROBE INCORPORATED
To: GOLDMAN SACHS BANK USA
Reel/Frame 028810/0745 →
TERMINATION OF PATENT SECURITY AGREEMENTS AND RELEASE OF SECURITY INTERESTS Recorded Aug 25, 2010
From: GOLDMAN SACHS CREDIT PARTNERS, L.P., AS COLLATERAL AGENT
To: HOLOGIC, INC.; R2 TECHNOLOGY, INC.; SUROS SURGICAL SYSTEMS, INC.; BIOLUCENT, LLC; DIRECT RADIOGRAPHY CORP.; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS LIMITED PARTNERSHIP; CYTYC SURGICAL PRODUCTS II LIMITED PARTNERSHIP; CYTYC SURGICAL PRODUCTS III, INC.; CYTYC PRENATAL PRODUCTS CORP.; THIRD WAVE TECHNOLOGIES, INC.
Reel/Frame 024944/0315 →
PATENT SECURITY AGREEMENT Recorded Jul 29, 2008
From: CYTYC CORPORATION
To: GOLDMAN SACHS CREDIT PARTNERS L.P., AS COLLATERAL AGENT
Reel/Frame 021301/0879 →
PATENT SECURITY AGREEMENT Recorded Oct 26, 2007
From: CYTYC CORPORATION
To: GOLDMAN SACHS CREDIT PARTNERS L.P.
Reel/Frame 020018/0529 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 5, 2004
From: KLAUTKY, TRUDEE; LAPEN, DANIEL
To: CYTYC CORPORATION
Reel/Frame 014230/0366 →