IP Library Granted Patent US 7,846,661
Granted Patent B2
US 7,846,661 · App. 11/606,651 · Granted Dec 7, 2010

Methods of detecting an amplified nucleic acid

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Quick Facts
Patent No.
US 7,846,661
App. No.
11/606,651
Granted
Dec 7, 2010
Kind
B2
Abstract

The present invention is directed to methods of generating a signal indicative of the presence of said target nucleic acid sequence in a sample, comprising, incubating a sample comprising a an amplified target nucleic acid and a nucleic acid polymerase which substantially lacks 5′ to 3′ exonuclease activity, adding a thermostable fen nuclease consisting of 5′ to 3′ exonuclease and/or endonuclease activity so as to cleave a cleavage structure and generate a signal.

Claims (28)

1. A method of amplifying a target nucleic acid and generating a signal indicative of the presence of said target nucleic acid in a sample, comprising:

in a composition comprising an amplified target nucleic acid and a nucleic acid polymerase which substantially lacks 5′ to 3′ exonuclease activity, adding a thermostable fen nuclease consisting of 5′ to 3′ exonuclease and/or endonuclease activity so as to cleave a cleavage structure and generate a signal, said cleavage structure comprising duplex nucleic acid comprising an amplified target nucleic acid strand duplexed to an oligonucleotide comprising a single-stranded 5′ flap, wherein generation of said signal is indicative of the presence of a target nucleic acid in said sample.

2. The method of claim 1 , wherein said nucleic acid polymerase is thermostable.

3. The method of claim 1 or 2 , said composition comprising an amplification primer which produces an amplified target nucleic acid.

4. The method of claim 1 or 2 , said composition comprising one or more dNTPs.

5. The method of claim 2 , wherein said nucleic acid polymerase is selected from the group consisting of Pfu, Pfu-exo, Taq, Taq-exo, Deep vent and Deep vent exo.

6. The method of claim 1 or 2 , wherein said fen nuclease is selected from the group consisting of fen nuclease enzyme of Archaeglobus fulgidus, Methanococcus jannaschii, Pyrococcus furiosus , and Pyrococcus horikoshii.

7. The method of claim 1 or 2 , wherein said 5′ flap is labeled.

8. The method of claim 7 , wherein said 5′ flap comprises a label comprising a first member of a pair of interactive labels effectively positioned to quench the generation of a detectable signal, the first and second members of said pair being separated by a site susceptible to fen nuclease cleavage, thereby allowing the nuclease activity of the fen nuclease to separate the first interactive signal generating labeled moiety from the second interactive signal generating labeled moeity by cleaving at said site susceptible to fen nuclease, thereby generating a signal.

9. The method of claim 8 , wherein said pair of interactive labels comprises a quencher moiety and a fluorescent moiety.

10. A method of amplifying a target nucleic acid and generating a signal indicative of the presence of said target nucleic acid in a sample, comprising:

in a composition, forming a cleavage structure comprising duplex nucleic acid and a 5′ single-stranded nucleic acid flap by amplifying a target nucleic acid in the presence of a nucleic acid polymerase and a primer specific for said target nucleic acid under conditions which are permissive for nucleic acid amplification, and, in the presence of a thermostable fen nuclease consisting of 5′ to 3′ exonuclease and/or endonuclease activity, permitting cleavage of said cleavage structure to generate a signal, wherein generation of said signal is indicative of the presence of a target nucleic acid in said sample.

11. The method of claim 10 , wherein said composition comprises one or more dNTPs.

12. The method of claim 10 , wherein said nucleic acid polymerase substantially lacks 5′ to 3′ exonuclease activity.

13. The method of claims 10 - 12 , wherein said nucleic acid polymerase is thermostable.

14. The method of claim 13 , wherein said nucleic acid polymerase is selected from the group consisting of Pfu, Pfu-exo, Taq, Taq-exo, Deep vent and Deep vent exo.

15. The method of claim 10 , wherein said fen nuclease is selected from the group consisting of fen nuclease enzyme of Archaeglobus fulgidus, Methanococcus jannaschii, Pyrococcus furiosus , and Pyrococcus horikoshii.

16. The method of claim 13 , wherein said 5′ flap is labeled.

17. The method of claim 16 , wherein said 5′ flap comprises a label comprising a first member of a pair of interactive labels effectively positioned to quench the generation of a detectable signal, the first and second members of said pair being separated by a site susceptible to fen nuclease cleavage, thereby allowing the nuclease activity of the fen nuclease to separate the first interactive signal generating labeled moiety from the second interactive signal generating labeled moeity by cleaving at said site susceptible to fen nuclease, thereby generating a signal.

18. The method of claim 17 , wherein said pair of interactive labels comprises a quencher moiety and a fluorescent moiety.

19. The method of claim 3 , wherein said primer is between about 10 to 100 nucleotides in length.

20. The method of claim 3 , wherein said primer is between about 17-50 nucleotides in length.

21. The method of claim 3 , wherein said primer is between about 17-45 nucleotides in length.

22. The method of claim 10 , wherein said primer is between about 10 to 100 nucleotides in length.

23. The method of claim 10 , wherein said primer is between about 17-50 nucleotides in length.

24. The method of claim 10 , wherein said primer is between about 17-45 nucleotides in length.

25. The method of claim 1 , wherein said Fen nuclease is a Fen-1 nuclease.

26. The method of claim 10 , wherein said Fen nuclease is a Fen-1 nuclease.

Assignments (9)
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: 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 →
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 →
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 26, 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 SURGICAL PRODUCTS II LIMITED PARTNERSHIP; CYTYC SURGICAL PRODUCTS LIMITED PARTNERSHIP; CYTYC CORPORATION; CYTYC SURGICAL PRODUCTS III, INC.; CYTYC PRENATAL PRODUCTS CORP.; THIRD WAVE TECHNOLOGIES, INC.
Reel/Frame 024892/0001 →
EIGHTH SUPPLEMENT TO PATENT SECURITY AGREEMENT Recorded Mar 26, 2009
From: CYTYC CORPORATION; HOLOGIC, INC.
To: GOLDMAN SACHS CREDIT PARTNERSL.P.
Reel/Frame 022456/0947 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2008
From: STRATAGENE CALIFORNIA
To: HOLOGIC INC.
Reel/Frame 021976/0268 →