	US 11,952,632 B2
	Kits and methods for detecting cancer-related mutations
Danny Frumkin, Rehovot (IL); Adam Wasserstrom, Ness Ziona (IL); and Revital Knirsh, Rosh HaAyin (IL)
Assigned to NUCLEIX LTD., Rehovot (IL)
Appl. No. 16/959,557
Filed by NUCLEIX LTD., Rehovot (IL)
PCT Filed Jan. 6, 2019, PCT No. PCT/IL2019/050027 § 371(c)(1), (2) Date Jul. 1, 2020, PCT Pub. No. WO2019/135241, PCT Pub. Date Jul. 11, 2019.
Claims priority of provisional application 62/614,421, filed on Jan. 7, 2018.
Prior Publication US 2020/0392586 A1, Dec. 17, 2020
Int. Cl. C12P 19/34 (2006.01); C12N 5/09 (2010.01); C12N 15/10 (2006.01); C12N 15/66 (2006.01); C12Q 1/6827 (2018.01); C12Q 1/6886 (2018.01); G01N 33/574 (2006.01)

CPC C12Q 1/6886 (2013.01) [C12N 5/0693 (2013.01); C12N 15/1089 (2013.01); C12N 15/66 (2013.01); C12Q 1/6827 (2013.01); G01N 33/574 (2013.01); C12Q 2537/165 (2013.01); C12Q 2565/40 (2013.01)]

20 Claims

1. A method for detecting a cancer-related mutation in a DNA sample, the method comprising:

(a) subjecting the DNA sample to digestion with a restriction endonuclease to obtain restriction endonuclease-treated DNA;

(b) co-amplifying from the restriction endonuclease-treated DNA a restriction locus comprising a cancer mutation site and a control locus, thereby generating an amplification product for each locus,

(c) calculating a ratio between signal intensities of the amplification products of the restriction locus and the control locus; and

(d) detecting the cancer-related mutation in the DNA sample by comparing the ratio calculated in step (c) to a predefined threshold ratio.