	US 12,006,555 B2
	Method to determine responsiveness of cancer to epidermal growth factor receptor targeting treatments
Daphne Winifred Bell, Kensington, MD (US); Daniel A. Haber, Chesnut Hill, MA (US); Pasi Antero Janne, Newton, MA (US); Bruce E. Johnson, Brookline, MA (US); Thomas J. Lynch, Newton, MA (US); Matthew Meyerson, Concord, MA (US); Juan Guillermo Paez, Dean Funes (AR); William R. Sellers, Chestnut Hill, MA (US); Jeffrey E. Settleman, Newton, MA (US); and Raffaella Sordella, Bedford, MA (US)
Assigned to The General Hospital Corporation; and Dana-Farber Cancer Institute, Inc.
Filed by The General Hospital Corporation, Boston, MA (US); and Dana-Farber Cancer Institute, Inc., Boston, MA (US)
Filed on Apr. 21, 2020, as Appl. No. 16/854,654.
Application 16/854,654 is a continuation of application No. 15/981,514, filed on May 16, 2018, granted, now 10,669,589.
Application 15/981,514 is a continuation of application No. 14/638,779, filed on Mar. 4, 2015, granted, now 10,000,815, issued on Jun. 19, 2018.
Application 14/638,779 is a continuation of application No. 13/896,772, filed on May 17, 2013, granted, now 9,035,036, issued on May 19, 2015.
Application 13/896,772 is a continuation of application No. 11/894,160, filed on Aug. 20, 2007, granted, now 8,465,916, issued on Jun. 18, 2013.
Application 11/894,160 is a continuation of application No. 11/294,621, filed on Dec. 5, 2005, granted, now 7,294,468, issued on Nov. 13, 2007.
Application 11/294,621 is a continuation of application No. PCT/US2005/010645, filed on Mar. 31, 2005.
Claims priority of provisional application 60/592,287, filed on Jul. 29, 2004.
Claims priority of provisional application 60/577,916, filed on Jun. 7, 2004.
Claims priority of provisional application 60/574,035, filed on May 25, 2004.
Claims priority of provisional application 60/565,753, filed on Apr. 27, 2004.
Claims priority of provisional application 60/565,985, filed on Apr. 27, 2004.
Claims priority of provisional application 60/561,095, filed on Apr. 9, 2004.
Claims priority of provisional application 60/558,218, filed on Mar. 31, 2004.
Prior Publication US 2021/0017604 A1, Jan. 21, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. C12Q 1/68 (2018.01); C12Q 1/48 (2006.01); C12Q 1/6886 (2018.01); G01N 33/574 (2006.01); G01N 33/74 (2006.01)

CPC C12Q 1/6886 (2013.01) [C12Q 1/485 (2013.01); G01N 33/574 (2013.01); G01N 33/74 (2013.01); C12Q 2600/106 (2013.01); C12Q 2600/118 (2013.01); C12Q 2600/136 (2013.01); C12Q 2600/156 (2013.01); C12Q 2600/158 (2013.01); C12Q 2600/16 (2013.01); G01N 2333/485 (2013.01); G01N 2800/52 (2013.01)]

16 Claims

1. An assay comprising:

(a) adding primers specific for at least one of the following nucleotide variances in an epidermal growth factor receptor (EGFR) gene, where the nucleotide variance is selected from:

i. a mutation in exon 18 that results in a substitution of cysteine for glycine at position 719 (G719C) or in a substitution of serine for glycine at position 719 (G719S) or in a substitution of an alanine for glycine at position 719 (G719A) of SEQ ID NO: 512;

ii. an in-frame deletion in exon 19 that results in a deletion of at least amino acids leucine, arginine, glutamic acid and alanine at codons 747, 748, 749, and 750 of SEQ ID NO: 512;

iii. a mutation in exon 20 that results in an insertion of amino acids asparagine, proline and glycine between position 770 and 771 (D770_N771insNPG), or in an insertion of amino acids serine, valine and aspartic acid between position 770 and 771 (D770_N771insSVD), or in an insertion of amino acid valine between position 772 and 773 (P772 H773insV), or in a substitution at position 790 of SEQ ID NO: 512; and

iv. a mutation in exon 21 that results in an amino acid substitution of arginine for leucine at position 858 (L858R) or of glutamine for leucine at position 861 (L861Q) of SEQ ID NO: 512;

to a biological sample obtained from the blood of a human patient afflicted with non-small cell lung cancer;

(b) performing an amplification step by polymerase chain reaction (PCR) wherein the PCR is allele-specific amplification for at least one of the nucleotide variances; and