TECHNOLOGY-THE Epinex G1A Test

Monthly measurement of glycation is the answer to improved diabetes control.

Glycated Albumin Testing
Glycation, the alteration of proteins in the body through exposure to excess sugar in the bloodstream caused by diabetes, is a principal underlying cause of the complications of diabetes. Albumin is a serum protein in the blood that can be measured with precision and has a turnover or replacement time of 2-3 weeks. Like many proteins in the body, albumin can become altered or glycated. High levels of glycated albumin have been directly linked to major complications of diabetes such as retinopathy (blindness) and nephropathy (kidney failure) through the damage caused to small blood vessels by the altered protein. It is also a marker for other types of diabetes complications. More than 25 years of clinical research has proven that monthly measurement of glycated albumin is a superior technology to monitor and control glycation.

 

The Epinex G1A™ Rapid Diabetes Monitoring Index Test is a monthly test for the control of glycation. The test is composed of the G1A™ reader and our proprietary dual-channel test cassette, which is able to simultaneously test for glycated albumin and total albumin. A drop of whole blood is placed on the sample well of the cassette and the cassette is inserted into the reader device. Based on our platform technology, the G1A™ reader automatically quantifies the analyte concentrations on the cassette and gives the G1A™ Index, the ratio of glycated albumin to total albumin in serum. The G1A™ Index shows how well the patients have controlled their level of glycation over the previous month. Simple to operate, the G1A™ test system can be performed at the point of care without the need for highly trained laboratory technicians. It allows for immediate feedback between healthcare provider and patients, thus facilitating timely therapeutic interventions. The results are stored on the device, providing trend analysis as well as displaying immediate results. The results can be transmitted by means of a computer or wireless connection to a doctor’s office or other central data location.

 

Advantages in relation to currently available diabetes monitoring techniques:

 

Type of Measurement

Period of Measurement

Testing Frequency

Function

Glucose

At a point in time

Once to several times daily

Tests fluctuations in blood glucose levels

HbA1c

4 to 6 month average

2 to 3 times a year

A measure of long-term glycation

Glycated Albumin (Epinex G1A™ Test)

1 month average

Once monthly

A specific index for monitoring glycation

* This product is under development, and is intended for information and evaluation process only. It is NOT APPROVED by the FDA.