US 12,433,573 B2
Sample collection and preservation devices, systems and methods
Ridhi Tariyal, Oakland, CA (US); and Stephen K. Gire, Oakland, CA (US)
Assigned to NEXTGEN JANE, INC., Oakland, CA (US)
Filed by NextGen Jane, Inc., Oakland, CA (US)
Filed on Nov. 13, 2023, as Appl. No. 18/507,494.
Application 18/507,494 is a continuation of application No. 17/888,136, filed on Aug. 15, 2022, granted, now 11,864,740.
Application 17/888,136 is a continuation of application No. 16/153,389, filed on Oct. 5, 2018, granted, now 11,446,011, issued on Sep. 20, 2022.
Application 16/153,389 is a continuation of application No. PCT/US2017/027482, filed on Apr. 13, 2017.
Claims priority of provisional application 62/460,329, filed on Feb. 17, 2017.
Claims priority of provisional application 62/321,987, filed on Apr. 13, 2016.
Prior Publication US 2024/0268797 A1, Aug. 15, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61B 5/107 (2006.01); A61B 5/00 (2006.01); A61B 10/00 (2006.01); B01L 3/00 (2006.01); C12Q 1/6806 (2018.01); A01N 1/122 (2025.01); A61B 10/02 (2006.01); C12M 1/30 (2006.01); C12Q 1/04 (2006.01); C12Q 1/6883 (2018.01); G01N 1/02 (2006.01)
CPC A61B 10/0045 (2013.01) [A61B 10/0096 (2013.01); B01L 3/00 (2013.01); B01L 3/5029 (2013.01); B01L 3/523 (2013.01); C12Q 1/6806 (2013.01); A01N 1/122 (2025.01); A61B 2010/0006 (2013.01); A61B 2010/0074 (2013.01); A61B 2010/0216 (2013.01); B01L 2200/0621 (2013.01); B01L 2200/16 (2013.01); B01L 2300/069 (2013.01); B01L 2300/0832 (2013.01); B01L 2300/0851 (2013.01); B01L 2400/0683 (2013.01); C12M 33/02 (2013.01); C12Q 1/04 (2013.01); C12Q 1/6883 (2013.01); C12Q 2600/158 (2013.01); G01N 2001/028 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A method for assaying for a presence or absence of a vaginal or menstrual microbiome, comprising:
obtaining a sample collector enclosed in an extractor, wherein the sample collector comprises an absorbent-diffuse material and is configured to collect a biological sample from a vaginal canal of a female subject wherein the biological sample comprises vaginal or menstrual fluid,
and wherein the vaginal or menstrual fluid is retained on the sample collector;
releasing or extracting nucleic acid from the sample collector with a solution comprised in the extractor, wherein a moveable compression element closes onto a breakable reagent compartment of the extractor to release the solution, wherein the solution contacts the sample collector when the sample collector is fully enclosed in the extractor, wherein the solution is free to flow between the sample collector and the extractor; and
subjecting the released or extracted nucleic acid to a sequencing analysis, whereby the sequencing analysis detects a presence or absence, or change of expression level of at least one biomarker indicative of a vaginal or menstrual microbiome.