IP Library Granted Patent US 11,286,530
Granted Patent B2
US 11,286,530 · App. 17/196,822 · Granted Mar 29, 2022

Methods for simultaneous amplification of target loci

Inventors: Matthew Rabinowitz (San Francisco, CA); Matthew Micah Hill (Belmont, CA); Bernhard Zimmermann (Manteca, CA); Johan Baner (San Francisco, CA); George Gemelos (Portland, OR); Milena Banjevic (Los Altos Hills, CA); Allison Ryan (Belmont, CA); Styrmir Sigurjonsson (San Jose, CA); Zachary Demko (San Francisco, CA)
Assignee: Natera, Inc.
C12Q1/6883C12Q1/6809C12Q1/6811C12Q1/6844C12Q1/6848C12Q1/6851C12Q1/6855C12Q1/6869C12Q1/6874C12Q2600/156
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Quick Facts
Patent No.
US 11,286,530
App. No.
17/196,822
Granted
Mar 29, 2022
Kind
B2
Abstract

The invention provides methods for simultaneously amplifying multiple nucleic acid regions of interest in one reaction volume as well as methods for selecting a library of primers for use in such amplification methods. The invention also provides library of primers with desirable characteristics, such as minimal formation of amplified primer dimers or other non-target amplicons.

Claims (27)

1. A method for amplifying and sequencing cell-free DNA, comprising:

performing a multiplex targeted pre-amplification of cell-free DNA isolated from a biological sample, wherein the pre-amplification is a linear amplification;

performing a first PCR to simultaneously amplify at least 10 target loci in one reaction volume using a first universal primer and at least 10 target-specific primers;

performing a second, nested PCR to simultaneously amplify the at least 10 target loci in one reaction volume using a second universal primer and at least 10 inner target-specific primers; and

performing high-throughput sequencing to sequence the amplified target loci and determine whether the target loci comprise a cancer-associated mutation, wherein the target loci are single nucleotide variant (SNV) loci.

2. The method of claim 1 , wherein the biological sample is a blood, plasma, serum, or urine sample.

3. The method of claim 1 , wherein the first PCR comprises simultaneously amplifying at least 20 target loci in one reaction volume.

4. The method of claim 1 , wherein the first PCR comprises simultaneously amplifying at least 50 target loci in one reaction volume.

5. The method of claim 1 , wherein the first PCR comprises simultaneously amplifying at least 100 target loci in one reaction volume.

6. The method of claim 1 , wherein the second PCR comprises simultaneously amplifying at least 20 target loci in one reaction volume.

7. The method of claim 1 , wherein the second PCR comprises simultaneously amplifying at least 50 target loci in one reaction volume.

8. The method of claim 1 , wherein the second PCR comprises simultaneously amplifying at least 100 target loci in one reaction volume.

9. The method of claim 1 , wherein the amplified target loci are tagged with molecular barcodes.

10. The method of claim 1 , wherein the amplified target loci are tagged with up to 1024 molecular barcodes.

11. The method of claim 1 , wherein the amplified target loci are tagged with 1024-65536 molecular barcodes.

12. The method of claim 1 , wherein at least one of the target specific primers comprises a tail, wherein the tail has no homology to the target loci and comprises a common priming site.

13. The method of claim 1 , wherein at least one of the target specific primers comprises a priming site for a subsequent amplification to add barcode sequences for multiplex sequencing.

14. The method of claim 1 , wherein the method further comprises barcoding PCR to introduce a sample-specific barcode, and wherein amplified DNAs from multiple samples are pooled together and sequenced in a single sequencing lane.

15. A method for amplifying and sequencing cell-free DNA, comprising:

performing a multiplex targeted pre-amplification of cell-free DNA isolated from a biological sample, wherein the pre-amplification is a linear amplification;

performing a multiplex targeted nested PCR to simultaneously amplify at least 10 target loci in one reaction volume; and

performing high-throughput sequencing to sequence the amplified target loci and determine whether the target loci comprise a cancer-associated mutation, wherein the target loci are single nucleotide variant (SNV) loci.

16. The method of claim 15 , wherein the multiplex targeted nested PCR comprises one-sided nested PCR.

17. The method of claim 15 , wherein the multiplex targeted nested PCR simultaneously amplifies least 20 target loci in one reaction volume.

18. The method of claim 15 , wherein the multiplex targeted nested PCR simultaneously amplifies at least 50 target loci in one reaction volume.

19. The method of claim 15 , wherein the amplified target loci are tagged with molecular barcodes.

20. The method of claim 15 , wherein the method further comprises barcoding PCR to introduce a sample-specific barcode, and wherein amplified DNAs of multiple samples are pooled together and sequenced in a single sequencing lane.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 18, 2022
From: BANER, JOHAN; BANJEVIC, MILENA; RYAN, ALLISON; DEMKO, ZACHARY
To: GENE SECURITY NETWORK, INC.
Reel/Frame 059052/0984 →
CHANGE OF NAME Recorded Feb 18, 2022
From: GENE SECURITY NETWORK INC.
To: NATERA, INC.
Reel/Frame 059203/0044 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 17, 2021
From: BABIARZ, JOSHUA; CONSTANTIN, TUDOR POMPILIU; EUBANK, LANE A.; GEMELOS, GEORGE; HILL, MATTHEW; KIRKIZLAR, HUSEYIN ESER; RABINOWITZ, MATTHEW; SAKARYA, ONUR; SIGURJONSSON, STYRMIR; ZIMMERMANN, BERNHARD
To: NATERA, INC.
Reel/Frame 055621/0087 →
Continuity (41)
Continuation 17061877 · Oct 2, 2020
Continuation 16399947 · Apr 30, 2019
Continuation 16140298 · Sep 24, 2018
Continuation 14918544 · Oct 20, 2015
Continuation In Part 14877925 · Oct 7, 2015
Continuation In Part 14692703 · Apr 21, 2015
Continuation In Part 14538982 · Nov 24, 2014
Continuation In Part 14225356 · Mar 25, 2014
Continuation In Part 13780022 · Feb 28, 2013
Continuation In Part 13683604 · Nov 21, 2012
Continuation In Part 13683604 · Nov 21, 2012
Continuation In Part PCTUS2012058578 · Oct 3, 2012
Continuation PCTUS2012058578 · Oct 3, 2012
Continuation In Part 13335043 · Dec 22, 2011
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13110685 · May 18, 2011
Continuation In Part 13110685 · May 18, 2011
Continuation In Part 13110685 · May 18, 2011
Continuation In Part 13110685 · May 18, 2011
Provisional Application 62148173 · Apr 15, 2015
Provisional Application 62147377 · Apr 15, 2015
Provisional Application 62146188 · Apr 10, 2015
Provisional Application 62066514 · Oct 21, 2014
Provisional Application 61994791 · May 16, 2014
Provisional Application 61987407 · May 1, 2014
Provisional Application 61982245 · Apr 21, 2014
Provisional Application 61683331 · Aug 15, 2012
Provisional Application 61675020 · Jul 24, 2012
Provisional Application 61634431 · Feb 29, 2012
Provisional Application 61542508 · Oct 3, 2011
Provisional Application 61571248 · Jun 23, 2011
Provisional Application 61516996 · Apr 12, 2011
Provisional Application 61448547 · Mar 2, 2011
Provisional Application 61462972 · Feb 9, 2011
Provisional Application 61426208 · Dec 22, 2010
Provisional Application 61398159 · Jun 21, 2010
Provisional Application 61395850 · May 18, 2010
Related Publication 20210189498A1 · Jun 24, 2021
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