IP Library Granted Patent US 9,677,118
Granted Patent B2
US 9,677,118 · App. 14/538,982 · Granted Jun 13, 2017

Methods for simultaneous amplification of target loci

Inventors: Bernhard Zimmermann (San Mateo, CA); Matthew Hill (Redwood City, CA); Philippe Lacroute (Sunnyvale, CA); Michael Dodd (San Francisco, CA); Alexander Wong (Mountain View, CA)
Assignee: Natera, Inc.
C12Q1/68C12Q1/6874C12Q1/6883C12Q2600/156
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Quick Facts
Patent No.
US 9,677,118
App. No.
14/538,982
Filed
Nov 24, 2014
Granted
Jun 13, 2017
Kind
B2
Art Unit
1637
USPC
435/6.12
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 of amplifying target loci in a nucleic acid sample, the method comprising:

(a) contacting a sample comprising target human loci with a library of at least 50 non-immobilized, non-identical primers that simultaneously hybridize to at least 50 non-identical target human loci to produce a reaction mixture; wherein the primers do not include molecular inversion probes (MIPs);

(b) subjecting the reaction mixture to primer extension reaction conditions to produce amplified products comprising target amplicons; wherein the annealing temperature for the reaction conditions is greater than a melting temperature of the at least 50 non-identical primers; wherein the length of the annealing step of the reaction conditions is greater than 5 minutes; and wherein at least 50 non-identical target human loci are simultaneously amplified; and

(c) sequencing the amplified products.

2. The method of claim 1 , wherein the annealing temperature is at least 3° C. greater than the melting temperature of the at least 50 non-identical primers.

3. The method of claim 1 , wherein the annealing temperature is at least 3° C. greater than the highest melting temperature of the at least 50 non-identical primers.

4. The method of claim 3 , wherein the annealing temperature is at least 8° C. greater than the highest melting temperature of the at least 50 non-identical primers.

5. The method of claim 1 , wherein the annealing temperature is at least 3° C. greater than the average melting temperature of the at least 50 non-identical primers.

6. The method of claim 5 , wherein the annealing temperature is at least 8° C. greater than the average melting temperature of the at least 50 non-identical primers.

7. The method of claim 1 , wherein the range of melting temperature of the at least 50 non-identical primers is between 1 to 5° C., inclusive.

8. The method of claim 1 , wherein the range of melting temperatures of the at least 50 non-identical primers is less than 5° C.

9. The method of claim 1 , wherein the ΔG values for each possible combination of two primers in the library are all equal to or greater than −5 kcal/mol.

10. The method of claim 1 , further comprising performing universal amplification on nucleic acids in the sample prior to step (a).

11. The method of claim 1 , wherein at least 50 of the primers have at least 90% identity to the corresponding region of SEQ ID Nos. 1-44,610.

12. The method of claim 1 , wherein the library comprises at least 500 non-immobilized, non-identical primers that simultaneously hybridize to the at least 500 non-identical target human loci, wherein the annealing temperature for the reaction conditions is greater than a melting temperature of the at least 500 non-identical primers, and wherein at least 500 non-identical target human loci are simultaneously amplified.

13. The method of claim 1 , wherein at least 90% of the amplified products are target amplicons.

14. The method of claim 1 , wherein at least 90% of the target human loci are amplified.

15. The method of claim 1 , wherein less than 20% of the amplified products are primer dimers.

16. The method of claim 1 , wherein the concentration of each primer in the library is less than 20 nM.

17. The method of claim 1 , wherein the at least 50 non-identical primers have 2, 1, or 0 guanines or cytosines in the last 5 bases at the 3′ end of the primers.

18. The method of claim 1 , wherein the at least 50 non-identical primers comprise a 5′ region that is not specific for a target human locus followed by a region that is specific for a target human locus, an internal region that is not specific for the target human locus and forms a loop structure, and a 3′ region that is specific for the target human locus.

19. The method of claim 1 , wherein the sample comprises maternal DNA from the pregnant mother of a fetus and fetal DNA, and wherein the method further comprises determining the presence or absence of a fetal chromosome abnormality from the sequencing data.

20. The method of claim 1 , wherein the sample comprises DNA from a single cell.

21. The method of claim 1 , wherein the annealing temperature is 1 to 15° C. greater than the highest melting temperature of the at least 50 non-identical primers.

22. The method of claim 1 , wherein the annealing temperature is 1 to 10° C. greater than the highest melting temperature of the at least 50 non-identical primers.

23. The method of claim 1 , wherein the library comprises at least 1000 non-immobilized, non-identical primer pairs that simultaneously hybridize to at least 1000 non-identical target human loci, wherein the annealing temperature for the reaction conditions is greater than a melting temperature of the at least 1000 non-identical primers, and wherein the at least 1000 non-identical target human loci are simultaneously amplified.

24. The method of claim 1 , wherein the length of the annealing step of the reaction conditions is between 5 and 60 minutes.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded Apr 22, 2020
From: ORBIMED ROYALTY OPPORTUNITIES II, LP
To: NATERA, INC.
Reel/Frame 052472/0712 →
SECURITY INTEREST Recorded Aug 8, 2017
From: NATERA, INC.
To: ORBIMED ROYALTY OPPORTUNITIES II, LP
Reel/Frame 043482/0472 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 24, 2015
From: ZIMMERMANN, BERNHARD; HILL, MATTHEW; DODD, MICHAEL; WONG, ALEXANDER; LACROUTE, PHILIPPE
To: NATERA, INC.
Reel/Frame 036173/0203 →
Continuity (5)
Provisional Application 61982245 · Apr 21, 2014
Provisional Application 61987407 · May 1, 2014
Provisional Application 61994791 · May 16, 2014
Provisional Application 62066514 · Oct 21, 2014
Related Publication 20150322507A1 · Nov 12, 2015