IP Library Granted Patent US 7,560,256
Granted Patent B2
US 7,560,256 · App. 11/168,374 · Granted Jul 14, 2009

Automated process for detecting the presence of a target nucleic acid in a sample

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Quick Facts
Patent No.
US 7,560,256
App. No.
11/168,374
Granted
Jul 14, 2009
Kind
B2
Abstract

An automated process for detecting the presence of a target nucleic acid in a sample. The process includes separating the target nucleic acid from other material present in the sample at a first station, transferring the separated target nucleic acid from the first station to a second station using a rotatable transport mechanism, combining the transferred target nucleic acid and reagents for performing an amplification reaction at the second station, and performing an amplification reaction. A product of the amplification reaction is detected as an indication of the presence of the target nucleic acid in the sample.

Claims (33)

1. A process for detecting the presence of a target nucleic acid in a sample containing the target nucleic acid, the process comprising the automated steps of:

a) at a first station, immobilizing the target nucleic acid on a magnetically responsive particle;

b) subjecting the magnetically responsive particle to a magnetic field and aspirating non-immobilized components of the sample;

c) transferring the target nucleic acid immobilized in step a) from the first station to a second station using a rotatable transport mechanism;

d) at the second station, combining the transferred target nucleic acid of step c) and reagents for performing an amplification reaction;

e) performing an amplification reaction which produces an amplification product indicative of the presence of the target nucleic acid in the sample; and

f) detecting the amplification product of step e) as an indication of the presence of the target nucleic acid in the sample.

2. The process of claim 1 , wherein the non-immobilized components of the sample include non-target nucleic acid.

3. The process of claim 1 , wherein the target nucleic acid is hybridized to a capture probe prior to immobilizing the target nucleic acid on the magnetically responsive particle.

4. The process of claim 1 , wherein the target nucleic acid remains immobilized on the magnetically responsive particle during step c).

5. The process of claim 1 further comprising the step of forming a complex comprising the amplification product and a probe, wherein the amplification product is detected in step f) by detecting the formation of the complex.

6. The process of claim 5 , wherein the probe includes a detectable label.

7. The process of claim 5 , wherein the amplification product is a nucleic acid sequence that is the same as or complementary to a sequence of the target nucleic acid.

8. The process of claim 1 , wherein steps a)-f) are performed with a stand-alone unit.

9. The process of claim 8 , wherein the first and second stations and the transport mechanism are contained within a housing of the stand-alone unit.

10. The process of claim 9 , wherein the first and second stations and the transport mechanism are located on a processing deck.

11. The process of claim 9 , wherein the stand-alone unit is movable.

12. The process of claim 1 , wherein the amplification reaction is selected from the group consisting of a polymerase chain reaction, a strand displacement amplification, and a transcription-associated amplification.

13. A process for detecting the presence of a target nucleic acid in a sample containing the target nucleic acid, the process comprising the automated steps of:

a) at a first station, immobilizing the target nucleic acid on a magnetically responsive particle; subjecting the magnetically responsive particle to a magnetic field and aspirating non-immobilized components of the sample; and washing the magnetically responsive particle one or more times with a wash solution;

b) transferring the target nucleic acid immobilized in step a) from the first station to a second station using a rotatable transport mechanism;

c) at the second station, combining the transferred target nucleic acid of step b) and reagents for performing an amplification reaction;

d) performing an amplification reaction which produces an amplification product indicative of the presence of the target nucleic acid in the sample; and

e) detecting the amplification product of step d) as an indication of the presence of the target nucleic acid in the sample.

14. The process of claim 13 , wherein the target nucleic acid remains immobilized on the magnetically responsive particle during step b).

15. The process of claim 13 further comprising the step of forming a complex comprising the amplification product and a probe, wherein the amplification product is detected in step e) by detecting the formation of the complex.

16. The process of claim 15 , wherein the probe includes a detectable label.

17. The process of claim 13 , wherein steps a)-e) are performed with a stand-alone unit.

18. The process of claim 17 , wherein the first and second stations and the transport mechanism are contained within a housing of the stand-alone unit.

19. The process of claim 18 , wherein the first and second stations and the transport mechanism are located on a processing deck.

20. The process of claim 18 , wherein the stand-alone unit is movable.

21. The process of claim 13 , wherein the amplification reaction is selected from the group consisting of a polymerase chain reaction, a strand displacement amplification, and a transcription-associated amplification.

22. The process of claim 15 , wherein the amplification product is a nucleic acid sequence that is the same as or complementary to a sequence of the target nucleic acid.

Assignments (7)
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 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 27, 2008
From: AMMANN, KELLY G.; BURNS, RALPH E.; HANSBERRY, ERNEST V.; HORNER, GLENN A.; JAKUB, CHERYL A.; KLING, JOHN E.; NIEGLOS, DONALD J.; SCHNEIDER, ROBERT E.; SMITH, ROBERT J.
To: GEN-PROBE INCORPORATED
Reel/Frame 021739/0321 →