Development-stage company Epinex Diagnostics (Irvine, California) said it has completed the development of a proof-of-concept prototype for a monthly rapid test to monitor Type 2 diabetes.

The company said such a test might provide information sooner to diabetics about whether or not they are doing a good job of managing their blood glucose levels by providing a measurement of glycated albumin, compared to total albumin in a person's bloodstream. It says that albumin is the most abundant protein in the bloodstream and is subject to damage by excess levels of sugar in the blood.

"[Our test] measures serum protein glycation, specifically glycated albumin, and compares it to total serum albumin; that's how it gives an index as a percentage," David Trasoff, PhD, director of communications at Epinex, told Diagnostics & Imaging Week. "There are a number of things that are important about that. One is it isn't just a value; its actually a normalized index. It gives you a reading that is normalized to the individual."

Trasoff explained that different people have different levels of serum protein, so rather than providing an absolute number "that would then need to be interpreted," the index provides a picture, or value, "relative to their system," he said.

The two primary ways of diabetes monitoring involve multiple daily blood glucose testing and the HbA1c test for long-term hemoglobin glycation. Daily testing may have to be done multiple times during the day, particularly for those on insulin, and it is often avoided by diabetics because of the pain of fingersticks and the expense of monitoring systems and test strips.

Trasoff said that research has shown that "there are a lot of factors that can affect how much of, and what sorts of, hemoglobin are present in the bloodstream at a given time," making the so-called "A1c" test highly variable.

"That's why there's a big push right now and a lot of work going on to find a way to standardize A1c, because it really isn't at the moment – never has been," he said.

While glycated albumin "has been available as a test for a long time in the clinical laboratory," there has never been a rapid albumin test, which is what makes the Epinex Diagnostic test unique.

Results from its test can be had in a matter of minutes. While there are "fairly well-established values" – or ranges — for the measurement of such tests, he said Epinex does not want to disclose any ranges for its test at this point.

"We're obviously going to refine that as we develop the test," he said.

The test will consist of a disposable test cassette and a handheld reader devices. Results will be displayed in five minutes.

Although the company submitted its preliminary patent application in 2003, the device is still patent-pending.

It was developed by the founders of Epinex, president/CEO Asad Zaidi and Dr. Henry Smith, chief technology officer. Epinex was founded in late 2002.

One of the problems with the A1c test, Trasoff said, is that hemoglobin in red blood cells are replaced about every 120 days.

Because of that, those with diabetes must wait a minimum of three months and a maximum of six months, to repeat the A1c test.

"Many people feel that that's quite a long time to measure," Trasoff said, adding that diabetics may find that damage may have been done based on their readings with A1c values, and they are faced with their healthcare provider as to how to treat that.

Epinex's objective is to have people complete its test at home, although it is expected to be available from physicians in addition to over-the-counter, to help them better manage their disease.

The company expects to go before the FDA in about 18 months, Trasoff said. And while the company cannot make any claims about its prototype test at this point, such a test on a monthly basis could potentially reduce daily blood glucose testing, as well as offer the potential to reduce long-term effects of diabetes.

Epinex said it has been financed through a Series A private placement memorandum, having raised about $3.2 million of $5 million it hopes to raise. It expects to continue fund-raising to "complete the shortfall of $1.8 million."

The company said it will use the funding to continue development of its prototype, pursuit of FDA approval and market introduction.

All importantly, the company said that it "anticipates that the test will be reimbursed, as it falls under the existing CPT code for Glycated Protein," under the Center for Medicare & Medicaid Services.