Devices and methods for biomarker detection process and assay of liver injury
AssigneeBanyan Biomarkers, Inc.
InventorsStanislav I. Svetlov, Ronald L. Hayes
Life of this patent
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Abstract
An in vitro diagnostic (IVD) device is used to detect the presence of and/or severity of liver injury in a subject. The IVD device relies on an immunoassay which identifies biomarkers that are diagnostic of liver injury in a biological sample, such as whole blood, plasma, serum. The inventive IVD device may measure one or more of several specific markers in a biological sample and output the results to a machine readable format wither to a display device or to a storage device internal or external to the IVD.
Claims25
An in vitro diagnostic device for detecting liver damage in a subject, the device comprising:
- a sample chamber for holding a first biological sample collected from the subject;
- an assay module in fluid communication with said sample chamber, said assay module containing an agent for detecting one or more biomarkers of a neural injury or neuronal disorder selected from the group consisting of:
- Argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), sulfuration (estrogen sulfotransferase (EST), squalene synthase (SQS), liver glycogen phosphorylase (GP), carbamoyl-phosphate synthetase (CPS-1), α-enolase 1, SULT2A1, glucose-regulated protein (GRP), wherein said assay module analyzes the first biological sample to detect the amount of the one or more biomarker present in said sample;
- a data processing module determines the measured amount of the respective biomarker present in the sample, an indication of the presence or absence of liver injuries, and/or an indication of the severity of liver injuries
- a user interface, wherein said user interface relates the amount of the one or more biomarker measured in the assay module to detecting liver damage in the subject or the severity of lover damage in the subject.
A method for using an in vitro diagnostic device for detecting liver damage in a subject, the method comprising:
- calibrating an in vitro diagnostic device incorporating an assay for measuring one or more biomarkers of liver damage in a biological sample, the one or more biomarkers selected from the group consisting of:
- Argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), sulfuration (estrogen sulfotransferase (EST), squalene synthase (SQS), liver glycogen phosphorylase (GP), carbamoyl-phosphate synthetase (CPS-1), α-enolase 1, SULT2A1, glucose-regulated protein (GRP);
- obtaining a biological sample from a subject;
- applying said sample to said in vitro diagnostic device wherein said assay includes reagents to determine the amount of the one or more biomarker present in said sample, wherein said device provides an output which relates the amount of the one or more biomarker detected to liver damage, or lack thereof, in the subject.
A method of treating liver damage in a subject:
- calibrating an in vitro diagnostic device incorporating an assay for measuring for one or more biomarkers in a biological sample, the one or more biomarkers selected from the group consisting of:
- (Argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), sulfuration (estrogen sulfotransferase (EST), squalene synthase (SQS), liver glycogen phosphorylase (GP), carbamoyl-phosphate synthetase (CPS-1), α-enolase 1, SULT2A1, glucose-regulated protein (GRP);
- obtaining a biological sample from a subject;
- applying said sample to said in vitro diagnostic device wherein said assay includes reagents to determine the amount of the one or more biomarker present in said sample, wherein said device provides an output which relates the amount of the one or more biomarker detected to liver damage, or lack thereof, in the subject, wherein if said output of said in vitro diagnostic device relates the amount of the one or more biomarker to liver damage, a therapeutic intervention is employed to treat injury and/or inhibit injury progression.
A process for electronically diagnosing liver injury or liver damage in a subject, the process comprising:
- an input signal from an assay module that has measured an amount of a liver biomarker in a biological sample;
- a software package providing instructions to a central processing unit for receiving and processing the input signal, comparing the input signal to a database of liver injury biomarker levels to determine if the amount if the input is greater than or less than the database amount stored on a memory unit of a data processing module, and translating the input data into usable indication of the presence or absence of the neurological condition;
- and
- communicating the usable indication to a graphical user interface to display the indication.
Dependencies are inferred from the claim text.