IP Library Granted Patent US 10,415,105
Granted Patent B2
US 10,415,105 · App. 15/198,818 · Granted Sep 17, 2019

Method and system for diagnostic testing

Inventors: Zachary Apte (San Francisco, CA); Jessica Richman (San Francisco, CA); Daniel Almonacid (San Francisco, CA)
Assignee: uBiome, Inc.
C12Q1/708A61B10/0096C12Q1/689
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Quick Facts
Patent No.
US 10,415,105
App. No.
15/198,818
Granted
Sep 17, 2019
Kind
B2
Abstract

An embodiment of a method for diagnostic testing includes: providing a sampling kit to a subject, the sampling kit including a sample container for reception of a sample from a collection site of the subject; receiving the sample from the subject; generating a microbiome sequence dataset based upon sequencing nucleic acid content of a microorganism portion of the sample; detecting a presence of a set of microbiome targets; generating a diagnostic analysis based on the detected set of microbiome targets; generating a therapy recommendation based on the set of microbiome targets; and promoting the therapy recommendation in coordination with presenting information derived from the diagnostic analysis.

Claims (17)

1. A method for characterizing human papillomavirus contemporaneously with generating analysis of a microbiome of an individual, comprising:

from a sample handling network, providing a sampling kit to the individual at a location remote from the sample handling network, the sampling kit including a sample container configured to receive a sample from a collection site of the individual;

at the sample handling network, receiving the sample container with the sample collected from the collection site of the individual;

at a sample processing module within the sample handling network, generating a microbiome composition dataset based upon sequencing nucleic acid content of a microorganism portion of the sample;

detecting a presence of a set of microbiome targets at the microbiome composition dataset, the set of microbiome targets associated with both: (1) a plurality of human papillomavirus types and (2) the microbiome of the individual;

generating a microbiome functional diversity dataset based on the detected set of microbiome targets;

generating an analysis informative of both: (1) diagnostic results for human papillomavirus, and (2) microbiome insights for the individual, based on the detected set of microbiome targets and the microbiome functional diversity dataset;

determining a microbiome modification therapy for improving health of the individual with human papillomavirus, based on the detected set of targets, the diagnostic results for human papillomavirus, and the microbiome functional diversity dataset; and

providing, to the individual at a user device associated with the individual, the microbiome modification therapy in coordination with presenting information derived from the analysis.

2. The method of claim 1 , wherein the microbiome functional diversity dataset comprises indicators of microbiome functions associated with a panel of sexually transmitted diseases, and wherein the microbiome modification therapy prompts a therapy configured to modify the microbiome functions associated with the panel of sexually transmitted diseases.

3. The method of claim 2 , wherein the panel of sexually transmitted diseases comprises human papillomavirus, wherein the microbiome functional diversity dataset comprises indicators of microbiome functions associated with human papillomavirus, and wherein the therapy modifies the microbiome functions associated with human papillomavirus.

4. The method of claim 1 , wherein the microbiome insights comprise a sample distribution of taxonomic groups of microorganisms present in the sample, and wherein presenting information derived from the analysis comprises presenting a first graphic depicting the sample distribution of taxonomic groups of microorganisms present in the sample compared to a distribution for a group of other individuals.

5. The method of claim 4 , wherein the sample distribution comprises a proportion of the plurality of human papillomavirus types, and wherein the first graphic depicts the proportion of the plurality of human papillomavirus types compared to a proportion of the plurality of human papillomavirus types for a group of other individuals.

6. The method of claim 5 , wherein providing the microbiome modification therapy comprises presenting a second graphic depicting efficacy of the microbiome modification therapy for a group of other individuals, in coordination with presenting the first graphic.

7. The method of claim 1 , wherein the microorganism portion comprises human papillomavirus microorganisms and other microorganisms, and wherein generating the microbiome composition dataset comprises generating the microbiome composition dataset based upon sequencing nucleic acid content of the human papillomavirus microorganisms and other microorganisms.

8. The method of claim 7 , wherein generating the microbiome composition dataset comprises processing the nucleic acid content of the human papillomavirus microorganisms and the other microorganisms with a fragmentation operation and a multiplexed amplification operation using a set of primers selected for the multiplexed amplification operation.

9. The method of claim 8 , wherein the selected set of primers comprises primers compatible with genital microbiome targets indicative of genital microbiome health, wherein the set of microbiome targets comprises the genital microbiome targets, wherein the microbiome insights comprise a genital microbiome health assessment of the individual, wherein determining the microbiome modification therapy comprises determining the microbiome modification therapy for improving both: (1) health of the individual with human papillomavirus and (2) the genital microbiome health assessment, and wherein presenting the information derived from the analysis comprises presenting the genital microbiome health assessment in coordination with presenting the microbiome modification therapy.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 14, 2020
From: UBIOME, INC.
To: PSOMAGEN, INC.
Reel/Frame 051586/0274 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 27, 2016
From: APTE, ZACHARY; RICHMAN, JESSICA; ALMONACID, DANIEL
To: UBIOME, INC.
Reel/Frame 039272/0235 →
Continuity (2)
Provisional Application 62186793 · Jun 30, 2015
Related Publication 20170002432A1 · Jan 5, 2017
Cited By (1)
US 12,242,943