US 12,444,478 B2
Noninvasive molecular clock for fetal development predicts gestational age and preterm delivery
Mira N. Moufarrej, Stanford, CA (US); Thuy T. M. Ngo, Stanford, CA (US); Joan Camunas-Soler, Stanford, CA (US); Mads Melbye, Copenhagen (DK); and Stephen R. Quake, San Francisco, CA (US)
Assigned to CZ Biohub SF, LLC, San Francisco, CA (US); The Board of Trustees of the Leland Stanford Junior University, Stanford, CA (US); and Statens Serum Institut, Copenhage (DK)
Appl. No. 16/758,844
Filed by CZ Biohub SF, LLC, San Francisco, CA (US); The Board of Trustees of the Leland Stanford Junior University, Stanford, CA (US); and Statens Serum Institut, Copenhagen (DK)
PCT Filed Oct. 23, 2018, PCT No. PCT/US2018/057142
§ 371(c)(1), (2) Date Apr. 23, 2020,
PCT Pub. No. WO2019/084033, PCT Pub. Date May 2, 2019.
Claims priority of provisional application 62/578,360, filed on Oct. 27, 2017.
Claims priority of provisional application 62/576,033, filed on Oct. 23, 2017.
Prior Publication US 2023/0140653 A1, May 4, 2023
Int. Cl. G16B 20/00 (2019.01); C12Q 1/6876 (2018.01); C12Q 1/6883 (2018.01); G16B 40/20 (2019.01); G16H 50/20 (2018.01)
CPC G16B 20/00 (2019.02) [C12Q 1/6883 (2013.01); G16B 40/20 (2019.02); G16H 50/20 (2018.01); C12Q 1/6876 (2013.01); C12Q 2600/158 (2013.01)] 11 Claims
 
1. A method for treating a pregnant subject for elevated risk of having preterm delivery, comprising:
(a) assaying a maternal sample obtained or derived from the pregnant subject to determine an expression profile of a panel of genes, wherein the panel of genes comprises three or more genes selected from the group consisting of CLCN3, DAPP1, POLE2, PPBP, LYPLAL1, MAP3K7CL, MOB1B, RAB27B, RGS18, and TBC1D15;
(b) computer processing the expression profile determined in (a) (i) against reference expression levels of the panel of genes or (ii) with a trained machine learning model;
(c) determining, based at least in part on the computer processing in (b), that the pregnant subject has an elevated risk of having the preterm delivery; and
(d) administering to the pregnant subject a therapeutic intervention for the elevated risk of having the preterm delivery, wherein the therapeutic intervention is selected from the group consisting of a progesterone, an antibiotic, a cervical cerclage, a cervical pessary, a folate supplement, and an omega-3 fatty acid supplement.