US 12,313,634 B2
Methods for prediction and early detection of diabetes
Kevin Huynh, Footscray (AU); Dianna Magliano, St Kilda West (AU); Jonathan Shaw, North Caulfield (AU); Mika Hilvo, Helsinki (FI); Reijo Laaksonen, Lempäälä (FI); and Peter Meikle, Lower Plenty (AU)
Assigned to ZORA BIOSCIENCES OY, Espoo (FI); and BAKER HEART AND DIABETES INSTITUTE, Melbourne (AU)
Appl. No. 16/762,612
Filed by Zora Biosciences Oy, Espoo (FI); and BAKER HEART AND DIABETES INSTITUTE, Melbourne (AU)
PCT Filed Nov. 20, 2018, PCT No. PCT/EP2018/081959
§ 371(c)(1), (2) Date May 8, 2020,
PCT Pub. No. WO2019/097089, PCT Pub. Date May 23, 2019.
Claims priority of provisional application 62/588,779, filed on Nov. 20, 2017.
Prior Publication US 2020/0348316 A1, Nov. 5, 2020
Int. Cl. G01N 33/68 (2006.01); G01N 33/92 (2006.01); G16H 10/60 (2018.01); G16H 20/10 (2018.01); G16H 50/20 (2018.01); G16H 50/30 (2018.01)
CPC G01N 33/6893 (2013.01) [G01N 33/92 (2013.01); G16H 10/60 (2018.01); G16H 20/10 (2018.01); G16H 50/20 (2018.01); G16H 50/30 (2018.01); G01N 2405/00 (2013.01); G01N 2800/042 (2013.01); G01N 2800/085 (2013.01)] 17 Claims
 
1. An in vitro method for assessing whether a subject is at risk to develop or is suffering from fatty liver disease and treating the subject indicated as being at risk to develop or suffering from fatty liver disease comprising:
(a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
(b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
(c) determining that the subject is suffering from or is at an increased risk of developing fatty liver disease, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control,
wherein the at least one fatty liver biomarker from Group E is not DAG(18:1/18:2), Cer(d18:1/24:0), Cer(d18:1/24:1), LPC(16:0) [sn1], LPC(16:0) [sn2], PC(34:2), PC(38:4), PC(38:6), PC(40:6), PE(38:2), PE(36:2), SM(42:1), SM(36:0), TG(16:0/16:0/18:1), TG(16:0/18:0/18:1), TG(16:0/18:1/18:1), and/or TG(16:0/16:0/16:0),
wherein the at least one fatty liver biomarker from Group F is LPC(MHDA) [sn1] and/or LPC(MHDA) [sn2], and
(d) treating the subject indicated as suffering from or at an increased risk of developing fatty liver disease,
wherein the treating comprises a lifestyle intervention to effect a change in diet, weight management and/or physical activity.