Apparatus and methods using tethered enzymes for the detection of the enzymatic activity of biomarkers
Inventors
Fischell, David R. • Cohen, Roy • Travis, Alexander J. • MUKHTAROV, FURKAT • JAICKS, JOHN MCGUIRE
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Assignees
Member
TETmedical, Inc.TETmedical, Inc. is a clinical-stage nanomedicine company specializing in advanced in vitro diagnostic platforms for acute and high-consequence diseases. Originating from research at Cornell University, the company leverages tethered enzyme technologies on nanoparticles to create rapid, sensitive, and robust molecular machines for detection of biomarkers. Their lead product is a rapid functional assay for stroke diagnosis, and their pipeline includes technologies for infectious disease detection and at-home liver function testing.
TETmedical, Inc. is a clinical-stage nanomedicine company specializing in advanced in vitro diagnostic platforms for acute and high-consequence diseases. Originating from research at Cornell University, the company leverages tethered enzyme technologies on nanoparticles to create rapid, sensitive, and robust molecular machines for detection of biomarkers. Their lead product is a rapid functional assay for stroke diagnosis, and their pipeline includes technologies for infectious disease detection and at-home liver function testing.
Publication Number
US-12306187-B2
Publication Date
2025-05-20
Expiration Date
Abstract
A coupled enzyme reaction point of care assay system detects and measures an active enzyme biomarker from a patient's blood sample. The assay system has a point of care blood collector for collecting blood into a blood collection vial. A biomarker detection mechanism has at least three fluid flow entities. Each fluid flow entity has a fluid input zone and a corresponding reaction zone. The fluid flow entities include a test strip, a negative control strip and a positive control strip. The reaction zones include components from a multiplicity of substrates, co-factors, buffers and cryoprotectants, and a multiplicity of tethered enzymes. At least one of the tethered enzymes is an enzyme that produces luminescence. The tethered enzymes are adapted to react to a constituent which may be a biomarker. A photonic luminescence reader measures light emitted from an active enzyme biomarker present in the patient's blood.
Core Innovation
A coupled enzyme reaction point of care assay system is described for detection and measurement of an active enzyme biomarker present in a sample of the blood of a patient. The system includes blood collection adapted to remove anti-oxidants from a collected blood sample, selected from uric acid and uricase, ascorbate oxidase and ascorbic acid, or glucose oxidase and glucose, together with a point of care blood collector that collects the patient’s blood into a blood collection vial for subsequent assay processing.
The biomarker detection mechanism includes at least three fluid flow entities, each having a fluid input zone and a corresponding reaction zone. Blood insertion places a preset amount of blood onto each fluid input zone, with at least one entity being a test strip, at least one being a negative control strip, and at least one being a positive control strip. The test strip and positive control strip each include a band between the fluid input zone and the reaction zone, where the band comprises a multiplicity of substrates that react with the active enzyme biomarker.
Each reaction zone comprises components including substrates, co-factors, buffers, and cryoprotectants, and at least two types of tethered enzymes. Each type includes at least 100 enzyme molecules tethered to a nanoparticle, and the reaction product formed from a reaction between the biomarker and one or more substrates in the band drives the tethered enzyme reactions in the corresponding reaction zone. The positive control strip includes a pre-set quantity of the enzyme biomarker, and a photonic luminescence reader measures the amplitude of light emitted from each reaction zone to calculate a measurement of the active enzyme biomarker from the light amplitude measurements.
Claims Coverage
Independent claim clm-00001 provides 5 main inventive feature areas: blood pretreatment for anti-oxidant removal, a three-entity fluid-flow test/control strip structure, substrate bands and reaction-zone component sets, nanoparticle-tethered multi-type enzymes with quantitative molecule tethering, and luminescence reading with calculated biomarker measurement using light amplitude and control strips.
Coupled enzyme reaction point of care assay system for active enzyme biomarker in patient blood
A coupled enzyme reaction point of care assay system for detection and measurement of an active enzyme biomarker present in a sample of the blood of a patient, including a blood collection vial adapted to remove anti-oxidants, a point of care blood collector, a biomarker detection mechanism with multiple fluid flow entities, and a photonic luminescence reader that calculates biomarker measurement from light amplitude.
Blood pretreatment to remove anti-oxidants in a blood collection vial
The blood collection vial includes pre-treatment materials adapted to remove anti-oxidants from a collected blood sample, selected from at least one of uric acid and uricase, ascorbate oxidase and ascorbic acid, or glucose oxidase and glucose.
Multi-entity fluid-flow test, negative control, and positive control strips with substrate band
The biomarker detection mechanism comprises at least three fluid flow entities with fluid input zones and corresponding reaction zones, including a test strip, a negative control strip, and a positive control strip. The test strip and positive control strip include a band between the fluid input zone and the reaction zone, the band comprising a multiplicity of substrates that react with the active enzyme biomarker.
Reaction zones with tethered enzymes on nanoparticles and multi-component reagent sets
Each reaction zone comprises substrates, co-factors, buffers and cryoprotectants, and at least two types of tethered enzymes. Each tethered enzyme type includes at least 100 enzyme molecules tethered to a nanoparticle, with enzyme molecules of a first tethered enzyme type adapted to react to a reaction product formed from a reaction between the biomarker and one or more other substrates in the band where present.
Positive control with pre-set biomarker quantity and photonic luminescence reader calculation from light amplitude
The positive control strip includes a pre-set quantity of the enzyme biomarker, and a photonic luminescence reader measures an amplitude of light emitted from each reaction zone. The photonic luminescence reader includes electronics adapted to calculate a measurement of an active enzyme biomarker present in the sample from the measurements of light amplitude from the reaction zones.
The independent claim centers on a point of care coupled enzyme reaction assay system that combines blood pretreatment to remove anti-oxidants, multiple fluid-flow test/control entities with substrate bands, reaction zones with defined component sets and nanoparticle-tethered enzymes, and luminescence measurement with electronics calculating biomarker measurement from light amplitude using a positive control strip with a pre-set biomarker quantity.
Stated Advantages
Documented Applications
No documented applications found
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