IP Library Granted Patent US 12,662,704
Granted Patent B2
US 12,662,704 · App. 17/196,722 · Granted Jun 23, 2026

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 12,662,704
App. No.
17/196,722
Granted
Jun 23, 2026
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 (15)

1 . A method comprising:

(a) performing multiplex targeted pre-amplification of at least 10 target loci from cell-free DNA isolated from a biological sample in a single reaction volume using at least 10 different target-specific primers to obtain amplified DNA, wherein the biological sample is a blood, plasma, serum, or urine sample;

(b) tagging the amplified DNA with a plurality of different molecular barcodes and a sequencing adapter to obtain molecularly barcoded amplified DNA; and

(c) performing high-throughput sequencing of the molecularly barcoded amplified DNA to sequence the at least 10 amplified target loci to generate sequence reads with a depth of at least 200 reads per target locus, wherein the target loci comprises a cancer-associated mutation, and wherein the target loci are single nucleotide variant (SNV) loci.

2 . The method of claim 1 , wherein at least 20 target loci are pre-amplified in a single reaction volume using at least 20 different target-specific primers to obtain amplified DNA.

3 . The method of claim 1 , wherein at least 50 target loci are pre-amplified in a single reaction volume using at least 50 different target-specific primers to obtain amplified DNA.

4 . The method of claim 1 , wherein at least 100 target loci are pre-amplified in a single reaction volume using at least 100 different target-specific primers to obtain amplified DNA.

5 . The method of claim 1 , wherein the amplified DNA is tagged with up to 1024 molecular barcodes.

6 . The method of claim 1 , wherein the amplified DNA is tagged with between 1024 to 65536 molecular barcodes.

7 . The method of claim 1 , wherein the biological sample is not obtained from a pregnant woman.

8 . The method of claim 1 , wherein 10 to 200 target loci are pre-amplified in a single reaction volume.

9 . The method of claim 1 , further comprising tagging the amplified DNA with a sample-specific barcode.

10 . The method of claim 1 , wherein the amplified DNA is tagged by ligation.

11 . The method of claim 1 , further comprising identifying the SNV loci with a limit of detection of less than 0.01%.

12 . The method of claim 1 , wherein the method does not comprise PCR amplification in a microfluidic device.