US 12,205,676 B2
Methods for treating Barrett's metaplasia and esophageal adenocarcinoma
Eric Matthew Gayle Ellsworth, Parsippany, NJ (US); Sydney David Finkelstein, Parsippany, NJ (US); Sara Ann Jackson, Parsippany, NJ (US); Brendan Corcoran, Parsippany, NJ (US); and Dennis Morgan Smith, Parsippany, NJ (US)
Assigned to Interpace Diagnostics Corporation, Parsippany, NJ (US)
Filed by Interpace Diagnostics Corporation, Parsippany, NJ (US)
Filed on Feb. 26, 2019, as Appl. No. 16/285,604.
Application 16/285,604 is a continuation of application No. 13/692,727, filed on Dec. 3, 2012, granted, now 10,255,410.
Claims priority of provisional application 61/661,256, filed on Jun. 18, 2012.
Claims priority of provisional application 61/640,527, filed on Apr. 30, 2012.
Claims priority of provisional application 61/565,879, filed on Dec. 1, 2011.
Prior Publication US 2020/0035324 A1, Jan. 30, 2020
This patent is subject to a terminal disclaimer.
Int. Cl. G16B 40/00 (2019.01); A61B 17/3205 (2006.01); A61B 17/3209 (2006.01); A61B 18/02 (2006.01); A61B 18/12 (2006.01); A61B 18/18 (2006.01); A61N 5/06 (2006.01); G16B 30/00 (2019.01)
CPC G16B 40/00 (2019.02) [A61B 17/3205 (2013.01); A61B 17/3209 (2013.01); A61B 18/18 (2013.01); A61N 5/0613 (2013.01); A61N 5/062 (2013.01); G16B 30/00 (2019.02); A61B 18/02 (2013.01); A61B 18/12 (2013.01)] 21 Claims
 
1. A method of treating Barrett's metaplasia, the method comprising:
amplifying DNA complementary to the microsatellite regions of 1q22, 1p34.2, 1p22.3, 1p36.21, 1p36.21, B Catenin E3, 3p25, 3p12.3, 3p22.3, 3p24.3, 3p26.3, 3p11.2, 3p24.2, C-KIT Ell, C-KIT E17, 5q23.1, 5q23.2, BRAF E15, EGFR E 19, EGFR E 21, 7p12.3, 7p12.1, 9p21.1, 9p23, 10q23.32, 10q23.33, HRAS1 E1, Kras2.E1, Kras2.E2, 17q22, 17q21.2, 17q11.2, 17p13.1 17p13, 17p13.1, 18q21.33, 19q13.2, 19q13.32, 21q21.2, 22q13.2, and Xp22.2 from a subject;
detecting the presence or absence of a mutation in the microsatellite regions;
categorizing clonality of each mutation;
calculating a mutational load based on the sum of low and high clonality mutations;
comparing the mutational load with a series of pre-determined mutational load cut-offs defining risk categories;
assigning the subject to a risk category corresponding to the subject's mutational load, wherein each risk category is indicative of the risk of disease progression;
determining if the subject is in a high risk category for disease progression from Barrett's metaplasia to esophageal adenocarcinoma; and
administering to the subject identified in the high risk category at least one treatment modality selected from endoscopic mucosal resection, endoscopic submucosal dissection, a therapeutically effective amount of radiofrequency ablation, a therapeutically effective amount of cryoablation, a therapeutically effective amount of photodynamic therapy and combinations thereof.