Epinex Diagnostics
Epinex Diagnostics specializes in developing innovative rapid diagnostic tests to address major deficiencies in healthcare, particularly in diabetes monitoring, kidney function, and coagulation. Founded in 2002 and located in Tustin, California, the company aims to improve patient outcomes by providing easy access to critical diagnostic information through proprietary technology and patented products, including the G1A test for glycated albumin, the ACR test for kidney health, and the SimplySure PT-INR test. Their mission is to enhance healthcare decision-making, reduce costs, and enable earlier intervention with point-of-care, OTC, and professional diagnostic solutions.
Industries
Nr. of Employees
small (1-50)
Epinex Diagnostics
Products
Monthly glycated albumin monitoring system (prototype)
A point-of-care/OTC test system composed of a dual-channel test cassette that measures a glycated serum protein and total serum protein from a drop of whole blood, plus a handheld reader that computes a ratio-based glycation index and stores/transmits results.
Point-of-care urine albumin/creatinine ratio test with reader (prototype)
A urine test kit including reagents and a disposable sample collection device; uses inhibition-based lateral-flow immunoassays and a fluorescence reader to quantify albumin and creatinine and compute the albumin/creatinine ratio for kidney disease screening.
Non-electronic microfluidic PT/INR test (prototype)
A microfluidic test for prothrombin time/INR designed to operate without an external electronic reader, intended as an alternative to PT/INR tests that require external digital devices.
Mobile diabetes screening application
A mobile phone application for diabetes-related screening and user information, intended to complement diagnostic offerings and provide user-facing digital health functionality.
Monthly glycated albumin monitoring system (prototype)
A point-of-care/OTC test system composed of a dual-channel test cassette that measures a glycated serum protein and total serum protein from a drop of whole blood, plus a handheld reader that computes a ratio-based glycation index and stores/transmits results.
Point-of-care urine albumin/creatinine ratio test with reader (prototype)
A urine test kit including reagents and a disposable sample collection device; uses inhibition-based lateral-flow immunoassays and a fluorescence reader to quantify albumin and creatinine and compute the albumin/creatinine ratio for kidney disease screening.
Non-electronic microfluidic PT/INR test (prototype)
A microfluidic test for prothrombin time/INR designed to operate without an external electronic reader, intended as an alternative to PT/INR tests that require external digital devices.
Mobile diabetes screening application
A mobile phone application for diabetes-related screening and user information, intended to complement diagnostic offerings and provide user-facing digital health functionality.
Services
Assay development and prototyping
Development of rapid immunoassay strips and cassette prototypes for point-of-care and over-the-counter diagnostic applications, including prototype reader integration.
Regulatory submission support
Assistance in preparing regulatory submission documents and strategies for device clearance and approvals, informed by management experience with 510(k), IDE and PMA filings.
Intellectual property and patent strategy support
Preparation and management of patent filings and international intellectual property strategy for diagnostic assays and devices.
Market research and commercialization advisory
Market segmentation, target-customer identification and go-to-market strategy for POC, physician office laboratory and OTC diagnostic channels.
Assay development and prototyping
Development of rapid immunoassay strips and cassette prototypes for point-of-care and over-the-counter diagnostic applications, including prototype reader integration.
Regulatory submission support
Assistance in preparing regulatory submission documents and strategies for device clearance and approvals, informed by management experience with 510(k), IDE and PMA filings.
Intellectual property and patent strategy support
Preparation and management of patent filings and international intellectual property strategy for diagnostic assays and devices.
Market research and commercialization advisory
Market segmentation, target-customer identification and go-to-market strategy for POC, physician office laboratory and OTC diagnostic channels.
Expertise Areas
- Point-of-care diagnostics
- Immunoassay and lateral-flow assay development
- Biomarker assay development and validation (glycated albumin)
- Handheld reader and embedded device software
Key Technologies
- Lateral-flow immunoassays
- Fluorescent label detection and optical readers
- Dual-channel / multiplex assay cassettes
- Handheld reader devices with embedded data storage