IP Library Granted Patent US 10,316,362
Granted Patent B2
US 10,316,362 · App. 14/918,544 · Granted Jun 11, 2019

Methods for simultaneous amplification of target loci

Inventors: Joshua Babiarz (Castro Valley, CA); Tudor Pompiliu Constantin (Berkeley, CA); Lane A. Eubank (San Carlos, CA); George Gemelos (Portland, OR); Matthew Micah Hill (Belmont, CA); Huseyin Eser Kirkizlar (Los Angeles, CA); Matthew Rabinowitz (San Francisco, CA); Onur Sakarya (Redwood City, CA); Styrmir Sigurjonsson (San Jose, CA); Bernhard Zimmermann (Manteca, CA)
Assignee: Natera, Inc.
C12Q1/6874C12Q1/6811C12Q1/6848C12Q1/6855C12Q1/6883C12Q2600/156
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Quick Facts
Patent No.
US 10,316,362
App. No.
14/918,544
Filed
Oct 20, 2015
Granted
Jun 11, 2019
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 (25)

1. A method of amplifying target loci of DNA molecules in a nucleic acid sample, the method comprising:

(a) contacting the sample and a library of at least 1,000 non-immobilized, non-identical primers that hybridize to at least 1,000 non-identical target loci to produce a reaction mixture in which the concentration of each primer is less than 20 nM; wherein the average length of the DNA molecules is less than 200 base pairs; and wherein a range of melting temperatures of the at least 1000 non-identical primers is less than 10° C.;

(b) subjecting the reaction mixture to PCR conditions to produce amplified products comprising target amplicons; wherein a length of an annealing step of the PCR conditions is greater than 10 minutes; wherein the length of the target amplicons is less than 100 nucleotides; wherein at least 1,000 different target human loci are amplified, and wherein at least 50% of the amplified products comprise target loci.

2. The method of claim 1 , wherein a range of melting temperatures of the at least 1000 non-identical primers is less than 5° C.

3. The method of claim 1 , further comprising performing universal amplification on DNA molecules in the sample prior to step (a).

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

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

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

7. The method of claim 1 , wherein the at least 1,000 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 humanlocus.

8. The method of claim 1 , wherein the sample comprises DNA from a pregnant mother and from her fetus, and wherein the method further comprises amplifying the amplified human loci and determining the presence or absence of a fetal chromosome abnormality from the sequencing data.

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

10. A method of amplifying target loci of DNA molecules in a nucleic acid sample, the method comprising:

(a) contacting the sample and a library of at least 1,000 non-immobilized, non-identical primers that hybridize to at least 1,000 non-identical target loci to produce a reaction mixture in which the concentration of each primer is less than 20 nM; wherein the average length of the DNA molecules is less than 200 base pairs;

(b) subjecting the reaction mixture to PCR conditions to produce amplified products comprising target amplicons; wherein a length of an annealing step of the PCR conditions is greater than 10 minutes; wherein the length of the target amplicons is less than 100 nucleotides; wherein at least 1,000 different target human loci are amplified, wherein at least 50% of the amplified products comprise target loci; and wherein the sample comprises or is derived from maternal blood.

11. The method of claim 10 , wherein the method further comprises sequencing the amplified human loci and making a genetic diagnosis, wherein the genetic diagnosis comprises detecting a gene mutation or detecting a ploidy state of the target human loci.

12. The method of claim 1 , wherein the length of the annealing step of the reaction conditions is between 10 and 60 minutes.

13. The method of claim 1 , wherein the concentration of primers in the reaction volume are less than 10 nM.

14. The method of claim 1 , wherein the concentration of primers in the reaction volume are less than 5 nM.

15. The method of claim 1 , wherein the library comprises at least 7,500 non-immobilized, non-identical primers that hybridize to at least 7,500 non-identical target human loci, and wherein the 7,500 non-identical target human loci are amplified.

16. The method of claim 1 , The library of claim 1 , wherein a range of guanine-cytosine (GC) content among the different test primers in the library is less than 30%.

17. The method of claim 14 , wherein a range of melting temperatures among the different primers in the library is less than 20° C.

18. The method of claim 15 , wherein a range of the length among the different target amplicons is less than 50 nucleotides.

19. A method of amplifying target loci of DNA molecules in a nucleic acid sample, the method comprising:

(a) contacting the sample and a library of at least 1,000 non-immobilized, non-identical primers that hybridize to at least 1,000 non-identical target loci to produce a reaction mixture in which the concentration of each primer is less than 20 nM; wherein the average length of the DNA molecules is less than 200 base pairs;

(b) subjecting the reaction mixture to PCR conditions to produce amplified products comprising target amplicons; wherein a length of an annealing step of the PCR conditions is greater than 10 minutes; wherein the length of the target amplicons is less than 100 nucleotides; wherein at least 1,000 different target human loci are amplified, wherein at least 50% of the amplified products comprise target loci; and wherein the target human loci comprise single nucleotidepolymorphisms.

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 Mar 14, 2017
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 042009/0316 →
Continuity (34)
Continuation In Part 14538982 · Nov 24, 2014
Continuation In Part 14692703 · Apr 21, 2015
Continuation In Part 14877925 · Oct 7, 2015
Continuation 13683604 · Nov 21, 2012
Continuation In Part 13780022 · Feb 28, 2013
Continuation In Part 14225356 · Mar 25, 2014
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13110685 · May 18, 2011
Continuation In Part 13335043 · Dec 22, 2011
Continuation In Part 13683604 · Nov 21, 2012
Continuation In Part PCTUS2012058578 · Oct 3, 2012
Continuation PCTUS2012058578 · Oct 3, 2012
Continuation In Part 13300235 · Nov 18, 2011
Continuation In Part 13110685
Continuation In Part 13300235
Provisional Application 62066514 · Oct 21, 2014
Provisional Application 62146188 · Apr 10, 2015
Provisional Application 62147377 · Apr 14, 2015
Provisional Application 62148173 · Apr 15, 2015
Provisional Application 61982245 · Apr 21, 2014
Provisional Application 61987407 · May 1, 2014
Provisional Application 61994791 · May 16, 2014
Provisional Application 61675020 · Jul 24, 2012
Provisional Application 61634431 · Feb 29, 2012
Provisional Application 61395850 · May 18, 2010
Provisional Application 61398159 · Jun 21, 2010
Provisional Application 61462972 · Feb 9, 2011
Provisional Application 61448547 · Mar 2, 2011
Provisional Application 61516996 · Apr 12, 2011
Provisional Application 61571248 · Jun 23, 2011
Provisional Application 61542508 · Oct 3, 2011
Provisional Application 61426208 · Dec 22, 2010
Provisional Application 61683331 · Aug 15, 2012
Related Publication 20160369333A1 · Dec 22, 2016
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