Daily, at-home blood glucose testing gives diabetics a way to monitor their glycemic control over the short term, and HbA1c testing gives a better picture long-term. Epinex Diagnostics Inc., a company developing a device to give doctors and patients an indication of their glycemic control over an intermediate term, revealed in a regulatory filing last week that it’s secured $318,000 from several investors and could continue raising up to $1.7 million in a private equity offering.
The test is based on glycated albumin. Albumin is a protein in the blood that becomes altered from exposure to excess sugar in the bloodstream. Research has found glycated albumin to be associated with a variety of diabetes complications (PDF) including kidney disease.
Because it has a replacement time of two to three weeks, albumin has been studied as a way to diagnose and monitor diabetes over an intermediate term to fill the gap between daily blood glucose monitoring and once- or twice-per-year hemoglobin A1c testing. Epinex proposes that monthly monitoring gives physicians better insight to modify treatments or identify potential complications earlier.
Glycated albumin testing is available now, but is done through a laboratory. Epinex proposes packaging its technology as a hand-held device. Here’s how it describes the device on its website:
“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.”
According to the website, one version is being created for use in a doctor’s office at the point of care, and another is being developed for over-the-counter use by patients.
Epinex isn’t exactly a startup. It was founded in 2002, but the Tustin, California, company still has yet to release its first product. A media representative did not respond to a request for an update on the company’s progress.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The American Diabetes Association estimates that 25.8 million Americans have diabetes, and they spend more than $15 billion a year managing the disease.
