IP Library Granted Patent US 12,618,795
Granted Patent B2
US 12,618,795 · App. 17/715,894 · Granted May 5, 2026

Methods for asymmetric semi-nested isothermal nucleotide amplification

Inventor: Anindita Roy (Salt Lake City, UT)
Assignee: SEEK LABS, INC.
G01N27/3276B01D29/05B01D29/58B01D39/16C12N9/1252C12N15/1017C12Q1/6806C12Q1/6853C12Q1/701C25F1/00C12Q2600/166
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,618,795
App. No.
17/715,894
Granted
May 5, 2026
Kind
B2
Abstract

Aspects of the present disclosure relate to methods, compositions, and systems for asymmetric semi-nested isothermal nucleotide amplification (ANINA) for the amplification of single-stranded oligonucleotides. In some aspects, the methods, compositions, and systems herein do not require thermal melting and may be used in a point-of-need setting. In some aspects, the methods feature amplification of a target region and production of single stranded amplicons including the target region.

Claims (46)

1 . A method of asymmetric semi-nested isothermal nucleotide amplification for producing single-stranded oligonucleotide amplicons comprising a target region of a template nucleic acid molecule, said method comprising:

a) introducing to a sample comprising the template nucleic acid molecule:

i) a set of primers comprising:

A) a first primer (P1) comprising a first template nucleotide sequence, wherein the entire first template nucleotide sequence is complementary to a first complementary binding region (CSBR1), wherein said P1 is 5′ to the target region, and wherein said CSBR1 is on a strand opposite to the target region;

B) a second primer (P2) comprising a second template nucleotide sequence, wherein the entire second template nucleotide sequence is complementary to a second complementary binding region (CSBR2), wherein P2 is (i) 5′ to the target region or (ii) 5′ to the target region and comprises a portion of the target region, wherein said CSBR2 is on a strand opposite to the target region, and wherein P1 is at least partially 5′ to P2; and

C) a third primer (P3) comprising a third template nucleotide sequence, wherein the entire third template nucleotide sequence is complementary to a target strand binding region (TSBR) of the target strand, wherein the TSBR comprises (i) at least a portion of the target region, (ii) a portion 3′ to the target region, or (iii) any combination of (i) and (ii),

wherein the ratio of P1:P2:P3 in the set of primers is (1-10):(10-200):(1-20); and

ii) a solution comprising one or more enzymes, one or more dNTPs, and a buffer, wherein the buffer comprises one or more buffering reagents, one or more salts, and one or more crowding reagents;

b) incubating the sample with the set of primers and the solution at a reaction temperature for a length of time; and

c) producing single-stranded oligonucleotide amplicons having a sequence comprising at least the target region of the template nucleic acid molecule.

2 . The method of claim 1 , wherein the ratio of P1:P2:P3 in the set of primers is 1:(10-200):10.

3 . The method of claim 1 , wherein the target region is from 20 to 500 bases in length.

4 . The method of claim 1 , wherein the buffer further comprises a reducing agent.

5 . The method of claim 1 , wherein the one or more enzymes comprise a recombinase enzyme, a single strand binding protein, a strand displacing polymerase, a reverse transcriptase, or a combination thereof.

6 . The method of claim 5 , wherein the recombinase enzyme is RecA, Rad51, or RadA.

7 . The method of claim 5 , wherein the single-stranded binding protein is Escherichia coli single-stranded DNA binding protein (EcSSB) or T4 GP32.

8 . The method of claim 5 , wherein the strand displacing polymerase is Bacillus subtilis DNA polymerase I (Bsu), or mesophilic DNA polymerase.

9 . The method of claim 1 , wherein the one or more buffering reagents are tris(hydroxymethyl)aminomethane (Tris), phosphate buffered saline (PBS), or a combination thereof.

10 . The method of claim 1 , wherein the one or more salts comprise sodium chloride (NaCl), potassium chloride (KCl), magnesium chloride (MgCl 2 ), sodium acetate (CH 3 COONa), magnesium acetate (Mg(CH 3 COO) 2 ), monosodium phosphate (NaH 2 PO 4 ), disodium phosphate (Na 2 HPO 4 ), or a combination thereof.

11 . The method of claim 1 , wherein the one or more crowding reagents are polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polysucrose, Dextran, or a combination thereof.

12 . The method of claim 1 , wherein the reaction temperature ranges from 15° C. to 60° C.

13 . The method of claim 1 , wherein the length of time is from 5 to 60 minutes.

14 . The method of claim 1 , wherein the buffer has a pH ranging from 7.0-8.0.

15 . The method of claim 1 , further comprising detecting the target region.

16 . The method of claim 15 , wherein detection of the target region comprises introducing a genosensor probe.

17 . A method of real time asymmetric semi-nested isothermal nucleotide amplification (ANINA) for producing and quantifying single-stranded oligonucleotide amplicons comprising a target region of a template nucleic acid molecule, said method comprising:

a) introducing to a sample comprising the template nucleic acid molecule:

i) a set of primers comprising:

A) a first primer (P1) comprising a first template nucleotide sequence, wherein the entire first template nucleotide sequence is complementary to a first complementary binding region (CSBR1), wherein said P1 is 5′ to the target region, and wherein said CSBR1 is on a strand opposite to the target region;

B) a second primer (P2) comprising a second template nucleotide sequence, wherein the entire second template nucleotide sequence is complementary to a second complementary binding region (CSBR2), wherein P2 is (i) 5′ to the target region or (ii) 5′ to the target region and comprises a portion of the target region, wherein said CSBR2 is on a strand opposite to the target region, and wherein P1 is at least partially 5′ to P2;

C) a third primer (P3) comprising a third template nucleotide sequence, wherein the entire third template nucleotide sequence is complementary to a target strand binding region (TSBR) of the target strand, wherein the TSBR comprises (i) at least a portion of the target region, (ii) a portion 3′ to the target region, or (iii) any combination of (i) and (ii),

wherein the ratio of P1:P2:P3 in the set of primers is (1-10):(10-200):(1-20); and

ii) a solution comprising one or more enzymes, one or more dNTPs, and a buffer, wherein the buffer comprises one or more buffering reagents, one or more salts, and one or more crowding reagents;

b) incubating the sample with the set of primers and the solution at a reaction temperature for a length of time; and

c) producing single-stranded oligonucleotide amplicons having a sequence comprising at least the target region of the nucleic acid molecule;

wherein the method quantifies the single-stranded oligonucleotide amplicons produced when the single-stranded oligonucleotide amplicons bind to a reporter probe.

18 . The method of claim 17 , wherein the one or more enzymes comprises a recombinase enzyme, a strand displacing polymerase, a reverse transcriptase, or a combination thereof.

19 . The method of claim 18 , wherein the recombinase enzyme is RecA, Rad51, or RadA.

20 . The method of claim 18 , wherein the strand displacing polymerase is Bacillus subtilis DNA polymerase I (Bsu), Bst, or Klenow Fragment.

21 . The method of claim 17 , wherein the one or more buffering reagents are tris(hydroxymethyl)aminomethane (Tris), phosphate buffered saline (PBS), or a combination thereof.

22 . The method of claim 17 , wherein the one or more salts is magnesium acetate (Mg(C 2 H 2 O 2 ) 2 ) or one or a combination of: sodium chloride (NaCl), potassium chloride (KCl), magnesium chloride (MgCl 2 ), sodium acetate (CH 3 COONa), monosodium phosphate (NaH 2 PO 4 ), and disodium phosphate (Na 2 HPO 4 ).

23 . The method of claim 17 , wherein the one or more crowding reagents comprise polyvinylpyrrolidone (PVP) and one or a combination of: polyethylene glycol (PEG), polysucrose, and Dextran.

24 . The method of claim 17 , wherein the solution further comprises a single stranded binding protein (SSB).

25 . The method of claim 24 , wherein the SSB is T4 gp32 SSB, E. coli SSB (EcSSB), or Bacillus subtilis DNA polymerase I (Bsu).

26 . The method of claim 17 , wherein the solution further comprises a reducing agent.

27 . The method of claim 17 , wherein the sample is in a second buffer comprising 20 mM phosphate buffered saline (PBS), 2.5 mM ethylenediaminetetraacetic acid (EDTA), and 0.05% sodium dodecyl sulfate (SDS).

Assignments (2)
CHANGE OF NAME Recorded Sep 29, 2023
From: CIBUS BIOTECHNOLOGIES, INC.
To: SEEK LABS, INC.
Reel/Frame 065086/0364 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2022
From: ROY, ANINDITA
To: CIBUS BIOTECHNOLOGIES, INC.
Reel/Frame 059735/0417 →
Continuity (4)
Provisional Application 63240227 · Sep 2, 2021
Provisional Application 63183504 · May 3, 2021
Provisional Application 63171761 · Apr 7, 2021
Related Publication 20220325337A1 · Oct 13, 2022
References Cited (58)
US 6503711B1 · Krull et al. · 2003 [cited by applicant]
US 6609618B2 · Colpan · 2003 [cited by applicant]
US 7264927B2 · Nargessi et al. · 2007 [cited by applicant]
US 8367334B2 · Pugh et al. · 2013 [cited by applicant]
US 8598338B2 · Bair et al. · 2013 [cited by applicant]
US 9238809B2 · Khripin et al. · 2016 [cited by applicant]
US 9540635B2 · Ruegg et al. · 2017 [cited by applicant]
US 9637777B2 · Seul et al. · 2017 [cited by applicant]
US 9696328B2 · Hansen et al. · 2017 [cited by applicant]
US 10392655B2 · Boutell et al. · 2019 [cited by applicant]
US 10550425B2 · Sampas et al. · 2020 [cited by applicant]
US 10704087B2 · Satterfield · 2020 [cited by applicant]
US 11180787B2 · Eboigbodin et al. · 2021 [cited by applicant]
US 20040191801A1 · Heeger et al. · 2004 [cited by applicant]
US 20070009925A1 · Fang et al. · 2007 [cited by applicant]
US 20070154922A1 · Collier et al. · 2007 [cited by applicant]
US 20080283741A1 · Mukaibatake · 2008 [cited by applicant]
US 20140080726A1 · Prakash · 2014 [cited by examiner]
US 20170096694A1 · Eboigbodin et al. · 2017 [cited by applicant]
US 20170152549A1 · Shih et al. · 2017 [cited by applicant]
US 20170198279A1 · Loper et al. · 2017 [cited by applicant]
US 20170233791A1 · Spier et al. · 2017 [cited by applicant]
US 20170362636A1 · Rajagopal · 2017 [cited by examiner]
US 20190376130A1 · Nobile et al. · 2019 [cited by applicant]
US 20200149030A1 · Hillebrand et al. · 2020 [cited by applicant]
US 20200200693A1 · Boyanov et al. · 2020 [cited by applicant]
US 20200391198A1 · Yi · 2020 [cited by applicant]
US 20210010065A1 · Salk et al. · 2021 [cited by applicant]
CN 102671487A · 2012 [cited by applicant]
EP 0585660B1 · 1994 [cited by applicant]
WO 2003040687A2 · 2003 [cited by applicant]
WO 2004094635A2 · 2004 [cited by applicant]
WO 2005118847A1 · 2005 [cited by applicant]
WO 2015022359A1 · 2015 [cited by applicant]
WO 2015185655A1 · 2015 [cited by applicant]
WO 2016041591A1 · 2016 [cited by applicant]
WO 2016144192A1 · 2016 [cited by applicant]
WO 2017218777A1 · 2017 [cited by applicant]
WO 2018195594A1 · 2018 [cited by applicant]
Francois, Patrice, et al. “Robustness of a loop-mediated isothermal amplification reaction for diagnostic applications.” FEMS Immunology & Medical Microbiology 62.1 (2011): 41-48 (Year: 2011). [cited by examiner]
Mason, Michael Glenn, and José Ramà [cited by examiner]
Mayboroda, Olena, et al. “Isothermal solid-phase amplification system for detection of Yersinia pestis.” Analytical and bioanalytical chemistry 408 (2016): 671-676. (Year: 2016). [cited by examiner]
Meyer, Ralph R., and Phyllis S. Laine. “The single-stranded DNA-binding protein of [cited by examiner]
Zhang, Zw. et al. (2005). Sensitive Detection of SARS Coronavirus by a Novel Asymmetric Multiplex Nested RT-PCR Amplification Coupled With Oligonucleotide Microarray Hybridization. In: Joos, T.O., Fortina, P. Methods in… [cited by examiner]
Yongxi Zhao, Feng Chen, Qian Li, Lihua Wang, and Chunhai Fan Isothermal Amplification of Nucleic Acids. Chemical Reviews 2015 115 (22), 12491-12545. DOI: 10.1021/acs.chemrev.5b00428. pp. 12493-12520. (Year: 2015). [cited by examiner]
Mitani, Y., Lezhava, A., Kawai, Y., Kikuchi, T., Oguchi-Katayama, A., Kogo, Y., Itoh, M., Miyagi, T., Takakura, H., Hoshi, K. and Kato, C., 2007. Rapid SNP diagnostics using asymmetric isothermal amplification and a new… [cited by examiner]
Satterfield, Brent C. “Cooperative Primers: 2.5 Million-Fold Improvement in the Reduction of Nonspecific Amplification.” The Journal of Molecular Diagnostics 16.2 (2014): 163-173. [cited by applicant]
Wong, Ian Y., and Nicholas A. Melosh. “An electrostatic model for DNA surface hybridization.” Biophysical journal 98.12 (2010): 2954-2963. [cited by applicant]
Xia, Xuhua. “The effect of probe length and GC% on microarray signal intensity: characterizing the functional relationship.” Int J Syst Synthetic Biol 1.2 (2010): 171-183. [cited by applicant]
Binder et al. “Mismatch and G-stack modulated probe signals on SNP microarrays.” PLoS One 4.11 (2009): e7862. [cited by applicant]
Gu et al. “Single molecule profiling of molecular recognition at a model electrochemical biosensor.” Journal of the American Chemical Society 140.43 (2018): 14134-14143. [cited by applicant]
Kudlicki, Andrzej S. “G-quadruplexes involving both strands of genomic DNA are highly abundant and colocalize with functional sites in the human genome.” PloS one 11.1 (2016): e0146174. [cited by applicant]
Yang et al. “Evidence for the direct interaction between methylene blue and guanine bases using DNA-modified carbon paste electrodes.” Electroanalysis: An International Journal Devoted to Fundamental and Practical Aspec… [cited by applicant]
Rohs et al. “Methylene blue binding to DNA with alternating GC base sequence: a modeling study.” Journal of the American Chemical Society 122.12 (2000): 2860-2866. [cited by applicant]
Pereira et al. “An efficient method for genomic DNA extraction from different molluscs species.” International journal of molecular sciences 12.11 (2011): 8086-8095. [cited by applicant]
Mason et al. “Rapid (30-second), equipment-free purification of nucleic acids using easy-to-make dipsticks.” Nature protocols 15.11 (2020): 3663-3677. [cited by applicant]
Zou et al. “Nucleic acid purification from plants, animals and microbes in under 30 seconds.” PLoS biology 15.11 (2017): e2003916. [cited by applicant]
Mason et al. “A simple, robust and equipment-free DNA amplification readout in less than 30 seconds.” RSC advances 9.42 (2019): 24440-24450. [cited by applicant]