US 12,331,360 B2
Risk determination for neoplasia and cancer
Matthias Durst, Jena (DE); Ingo B. Runnebaum, Jena (DE); Martina Schmitz, Jena (DE); and Alfred Hansel, Jena (DE)
Assigned to Oncgnostics GmbH, Jena (DE)
Appl. No. 16/650,849
Filed by oncgnostics GmbH, Jena (DE)
PCT Filed Sep. 29, 2017, PCT No. PCT/EP2017/074829
§ 371(c)(1), (2) Date Mar. 25, 2020,
PCT Pub. No. WO2019/063097, PCT Pub. Date Apr. 4, 2019.
Prior Publication US 2020/0216911 A1, Jul. 9, 2020
Int. Cl. C12Q 1/6886 (2018.01)
CPC C12Q 1/6886 (2013.01) [C12Q 2600/154 (2013.01)] 33 Claims
 
1. A method for determining the risk for developing neoplasia in cervical, vaginal, urethral, or anogenital tissue of a human patient which cervical, vaginal, urethral, or anogenital tissue, respectively, shows no histopathological indication of neoplasia, the method comprising:
(a) determining the methylation status of one or more regions of genomic DNA associated with the gene ZNF671 in a biological sample containing cells of the cervical, vaginal, urethral, or anogenital tissue, respectively, obtained from the patient, wherein the one or more regions of genomic DNA associated with the gene ZNF671 can be detected with an oligonucleotide probe having the nucleic acid sequence of SEQ ID NO: 3 and wherein the one or more regions of genomic DNA associated with the gene ZNF671 comprises a region of genomic DNA that can be amplified by a primer pair comprising a first primer having the nucleic acid sequence of SEQ ID NO: 1 and a second primer having the nucleic acid sequence of SEQ ID NO: 2, and wherein when the one or more regions is methylated in the biological sample, the patient has an increased risk for developing neoplasia in the tissue compared to a human patient in which the regions are not methylated; and
(b) administering to the patient having an increased risk for developing neoplasia in the cervical, vaginal, urethral, or anogenital tissue, respectively, a medicament to reduce risk of neoplasia in the tissue.