IP Library Granted Patent US 11,332,793
Granted Patent B2
US 11,332,793 · App. 16/777,700 · Granted May 17, 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.
C12Q1/6883C12Q1/6809C12Q1/6811C12Q1/6844C12Q1/6848C12Q1/6851C12Q1/6855C12Q1/6874C12Q2600/156
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Quick Facts
Patent No.
US 11,332,793
App. No.
16/777,700
Granted
May 17, 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 (53)

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

isolating cell-free DNA from a biological sample and tagging the isolated cell-free DNA, wherein each tagged DNA molecule comprises a molecular barcode;

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

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

performing high-throughput sequencing to sequence the amplified DNA comprising the target 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 method comprises subjecting the isolated cell-free DNA to blunting ending, dA-tailing, and adaptor ligation, wherein the adaptor comprises a universal priming site and the molecular barcode.

4. The method of claim 1 , wherein the second PCR is one-sided nested PCR.

5. The method of claim 1 , wherein the first PCR comprises simultaneously amplifying between 100 and 5,000 target loci using the first universal primer and between 100 and 5,000 target specific primers in a single reaction volume.

6. The method of claim 5 , wherein the second PCR comprises simultaneously amplifying between 100 and 5,000 target loci using the second universal primer and between 100 and 5,000 target-specific primers in a single reaction volume.

7. The method of claim 1 , wherein the first PCR comprises simultaneously amplifying between 1000 and 1,000 target loci using the first universal primer and between 100 and 1,000 inner target-specific primers in a single reaction volume.

8. The method of claim 7 , wherein the second PCR comprises simultaneously amplifying between 100 and 1,000 target loci using the second universal primer and between 100 and 1,000 inner target-specific primers in a single reaction volume.

9. The method of claim 1 , wherein the isolated cell-free DNA are tagged with up to 1024 different molecular barcodes.

10. The method of claim 1 , wherein the isolated cell-free DNA are tagged with 1024-65536 different molecular barcodes.

11. The method of claim 1 , wherein each target-specific primer of the first and/or second PCR has a concentration of less than 20 nM.

12. The method of claim 1 , wherein each target-specific primer of the first and/or second PCR has a concentration of less than 10 nM.

13. The method of claim 1 , wherein the first and/or second PCR comprises an annealing step having a length of at least 3 minutes.

14. The method of claim 1 , wherein the first and/or second PCR comprises an annealing step having a length of at least 5 minutes.

15. The method of claim 1 , wherein at least 90% of the amplified DNA map to the target loci.

16. The method of claim 1 , wherein the target loci are SNP loci.

17. The method of claim 1 , wherein the cell-free DNA comprises DNA from mixed origin.

18. The method of claim 17 , wherein the cell-free DNA comprises DNA from a fetus.

19. The method of claim 17 , wherein the cell-free DNA comprises DNA from a tumor.

20. The method of claim 17 , wherein the cell-free DNA comprises DNA from a transplant.

21. The method of claim 7 , wherein amplified DNAs of multiple samples are pooled and sequenced in a single sequencing lane.

22. A method for preparing an enriched deoxyribonucleic acid (DNA) fraction of cell-free DNA (cfDNA) useful for analyzing target loci, comprising:

a. extracting cfDNA from a biological sample;

b. producing an enriched fraction of the cfDNA extracted in (a) by:

i. ligating adaptors to the cfDNA, wherein the adaptors each comprises a universal priming sequence and a molecular barcode;

ii. performing a first amplification to simultaneously amplify at least 10 target loci from the cfDNA using a first universal primer and at least 10 target-specific primers in a single reaction volume;

iii. performing a second, nested amplification to simultaneously amplify the at least 10 target loci using a second universal primer and at least 10 inner target-specific primers in a single reaction volume, wherein at least one of the primers comprises a sequencing tag;

c. analyzing the target loci by performing high-throughput sequencing to sequence the enriched fraction of the cfDNA comprising the target loci.

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

24. The method of claim 23 , wherein the method comprises subjecting the cfDNA extracted in (a) to blunting ending, dA-tailing, and adaptor ligation.

25. The method of claim 22 , wherein the second amplification is one-sided nested PCR.

26. The method of claim 22 , wherein the method comprises multiplex sequencing of the enriched fraction of the cfDNA from multiple samples in a single sequencing lane.

27. The method of claim 22 , wherein the first amplification comprises simultaneously amplifying between 100 and 5,000 target loci using the first universal primer and between 100 and 5,000 target specific primers in a single reaction volume.

28. The method of claim 27 , wherein the second amplification comprises simultaneously amplifying between 100 and 5,000 target loci using the second universal primer and between 100 and 5,000 target-specific primers in a single reaction volume.

29. The method of claim 22 , wherein the first amplification comprises simultaneously amplifying between 100 and 1,000 target loci using the first universal primer and between 100 and 1,000 inner target-specific primers in a single reaction volume.

30. The method of claim 29 , wherein the second amplification comprises simultaneously amplifying between 100 and 1,000 target loci using the second universal primer and between 100 and 1,000 inner target-specific primers in a single reaction volume.

31. The method of claim 22 , wherein the cfDNA extracted in (a) are tagged with up to 1024 different molecular barcodes.

32. The method of claim 22 , wherein the cfDNA extracted in (a) are tagged with 1024-65536 different molecular barcodes.

33. The method of claim 22 , wherein each target-specific primer of the first and/or second amplification has a concentration of less than 20 nM.

34. The method of claim 22 , wherein each target-specific primer of the first and/or second amplification has a concentration of less than 10 nM.

35. The method of claim 22 , wherein the first and/or second amplification comprises an annealing step having a length of at least 3 minutes.

36. The method of claim 22 , wherein the first and/or second amplification comprises an annealing step having a length of at least 5 minutes.

37. The method of claim 22 , wherein at least 90% of the enriched fraction of the cfDNA map to the target loci.

38. The method of claim 22 , wherein the target loci are SNP loci.

39. The method of claim 22 , wherein the cfDNA extracted in (a) comprises DNA from mixed origin.

40. The method of claim 22 , wherein the cfDNA extracted in (a) comprises DNA from a patient suspected of having cancer.

41. The method of claim 39 , wherein the cfDNA extracted in (a) comprises DNA from a tumor.

42. The method of claim 39 , wherein the cfDNA extracted in (a) comprises DNA from a transplant.

43. The method of claim 28 , wherein the enriched fraction of the cfDNA from multiple samples are pooled and sequenced in a single sequencing lane.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 30, 2020
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 051761/0745 →
Continuity (39)
Continuation 16399103 · 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 13683604 · Nov 21, 2012
Continuation PCTUS2012058578 · Oct 3, 2012
Continuation In Part 13335043 · Dec 22, 2011
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13110685 · May 18, 2011
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13110685 · May 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
Provisional Application 62148173 · Apr 15, 2015
Provisional Application 62147377 · Apr 14, 2015
Provisional Application 62146188 · Apr 10, 2015
Provisional Application 62066514 · Oct 21, 2014
Provisional Application 62148173 · Apr 15, 2015
Provisional Application 62994791 · May 16, 2014
Provisional Application 62987407 · May 1, 2014
Provisional Application 62982245 · Apr 21, 2014
Provisional Application 61634431 · Feb 29, 2012
Provisional Application 61675020 · Jul 24, 2012
Provisional Application 61683331 · Aug 15, 2012
Provisional Application 61542508 · Oct 3, 2011
Provisional Application 61426208 · Dec 22, 2010
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 61398159 · Jun 21, 2010
Provisional Application 61395850 · May 18, 2010
Related Publication 20200157629A1 · May 21, 2020
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