US 2026/0242856 A1 · Diagnostic Platform

Abstract

A diagnostic platform comprises a fluid-accessible sampling assembly configured to capture, concentrate, and detect biomarkers from saliva, gingival crevicular fluid, or other oral fluids for disease screening, diagnosis, and monitoring. The platform includes a porous or composite sampling matrix retained within a fluid-permeable enclosure and is organized around four core module families: a capture-configuration module with heterogeneous material architecture providing spatially distinct capture regions that selectively bind distinct biomarkers; a transport or recruitment module biasing fluid and biomarker movement through capillary, electrostatic, and pore-structure effects; an integrated signal-generation module enabling colorimetric, fluorescent, electrochemical, or optical detection at the sampling assembly; and a fractionated recovery-flow module for staged, enriched analyte extraction. The platform achieves concentration factors of 102 to 105, enabling multiplex detection of low-abundance biomarkers including proteins, nucleic acids, extracellular vesicles, and metabolites relevant to infectious disease, cancer, diabetes, cardiovascular disease, and inflammatory disorders.

Claims20

Dependent claims

A diagnostic system configured to generate a detectable signal corresponding to one or more biomarkers in a biological fluid, the system comprising:

a sampling subsystem comprising a fluid-accessible sampling matrix positioned within a fluid-permeable enclosure;
and
a detection subsystem comprising at least one signal-generating element configured to generate the detectable signal corresponding to the one or more biomarkers;
wherein the sampling subsystem is configured to preferentially increase a quantity of the one or more biomarkers bound to one or more immobilized capture domains in the sampling matrix relative to at least one other biological compound present in the biological fluid by at least one of:
(a) a migration-biasing structure configured to generate a transport-driving gradient that produces differential migration of the one or more biomarkers relative to other biological compounds prior to binding by the one or more immobilized capture domains;
or
(b) the fluid-accessible sampling matrix being heterogeneous and including a plurality of capture regions each presenting one or more immobilized capture domains, the heterogeneous fluid-accessible sampling matrix arranged such that biological fluid is differentially exposed to the plurality of capture regions, the plurality of capture regions selectively capturing at least one of the one or more biomarkers relative to other biological compounds;
and wherein a volume of biological fluid contacted by the sampling subsystem during operation exceeds a volume of fluid delivered to the detection subsystem by at least one order of magnitude.

5 more elements

A diagnostic platform configured to generate one or a plurality of diagnostic signals corresponding to one or more biomarkers in a biological fluid, the platform comprising:

a sampling system comprising:
a sampling matrix including at least one capture region presenting at least one immobilized capture domain capable of binding the one or more biomarkers;
and
a fluid-permeable enclosure positioned relative to the sampling matrix so as to retain the sampling matrix during sampling, the enclosure comprising at least one fluid-permeable region configured to permit exchange of biological fluid between an external environment and the sampling matrix;
and
one or more signal-generating elements integrated into or onto the sampling system and configured to generate the one or plurality of diagnostic signals based on the one or more biomarkers associated with the sampling matrix, wherein the one or more signal-generating elements comprise at least one of:
(i) sensing elements integrated into or onto the sampling matrix;
(ii) sensing elements integrated into or onto the fluid-permeable enclosure;
or
(iii) signal-generating elements introduced into contact with the sampling matrix after biomarker binding.

7 more elements

A method of generating a detectable signal corresponding to at least one biomarker in a biological fluid, comprising:

a) contacting the biological fluid with a sampling subsystem comprising a fluid-accessible sampling matrix including one or more capture regions presenting at least one immobilized capture domain capable of binding the at least one biomarker;
b) binding at least a portion of the at least one biomarker within the sampling matrix;
c) placing the sampling subsystem in fluid communication with a detection subsystem through a fluidic transport network;
d) obtaining, by selective extraction from the sampling matrix through the fluidic transport network, a first fluid fraction that contains a different amount of the at least one biomarker relative to a second fluid fraction remaining within or subsequently extracted from the sampling matrix;
and
e) generating, in the detection subsystem, the detectable signal corresponding to the at least one biomarker based on the fluid fractions.

3 more elements

Dependencies are inferred from the claim text.

Diagnostic Platform

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Diagnostic Platform

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Abstract

Claims20