	US 11,932,907 B2
	Fetal sex determination using capillary blood from upper arm
Christopher Jacob, La Jolla, CA (US)
Assigned to Gateway Genomics, LLC, La Jolla, CA (US)
Filed by GATEWAY GENOMICS, LLC, La Jolla, CA (US)
Filed on Apr. 26, 2023, as Appl. No. 18/307,666.
Application 18/307,666 is a continuation of application No. 17/762,680, abandoned, previously published as PCT/US2020/052187, filed on Sep. 23, 2020.
Claims priority of provisional application 62/936,329, filed on Nov. 15, 2019.
Claims priority of provisional application 62/903,945, filed on Sep. 23, 2019.
Prior Publication US 2023/0257811 A1, Aug. 17, 2023
Int. Cl. C12P 19/34 (2006.01); C12Q 1/6806 (2018.01); C12Q 1/6879 (2018.01)

CPC C12Q 1/6879 (2013.01) [C12Q 1/6806 (2013.01)]

14 Claims

1. A method of improving the accuracy of fetal sex determination by reducing a level of contaminating DNA in a blood sample from a pregnant human subject, the method comprising:

a.) obtaining a 100-750 μl capillary blood sample that was collected from the upper arm of the human subject into a tube using a push-button blood collection device, thereby reducing a level of contaminating DNA from a non-maternal and non-fetal source in the capillary blood sample as compared to a blood sample from the subject collected from a site on the finger or hand of the subject;

b.) separating plasma from the capillary blood sample;

c.) isolating cell-free nucleic acids from the plasma; and

d.) performing PCR on the cell-free nucleic acid to detect the presence or absence of fetal Y-chromosome nucleic acids in the capillary blood sample, thereby determining the sex of the fetus.