CAMLAW: Complementary and Alternative Medicine Law Blog

Diabetes tests by Exocell/Glycadia indicate kidney damage

Exocell (Glycadia Pharmaceuticals), a biotechnology company located in Philadelphia, has developed a number of tests for early markers of diabetes and diabetic complications, as well as tools for clinical testing of diabetes drugs.

According to the Exocell website, diabetes means having a high blood sugar, which can damage the kidneys, eyes, and other organs:

+ More than 30% of people with diabetes develop kidney failure
+ About 12% of people with diabetes suffer serious loss of vision

The first indication of kidney damage is an elevated urinary albumin content. A subtle increase in the amount of albumin in the urine, known as microalbuminuria, is the earliest sign of diabetic kidney disease. This should be measured at least annually (more often if microalbuminuria is present). It is a good idea to test 2 or 3 different urine specimens over several months. Normalization against urinary creatinine is recommended.

Albuwell and Dialbumin are Exocell's products for specific and reliable measurement of microalbuminuria in patients with diabetes. Creatinine Companion may be used to measure urinary creatinine. These products are available through the Exocell/Glycadia website.

Higher than normal blood sugar accelerates non-enzymatic glycation of proteins, and increases the risk for complications of diabetes. Exocell has a number of products and test kits designed to measure these modified proteins.

Glycated hemoglobin reflects the average blood sugar during the preceding 2-3 month period. Exocell provides purified glycated hemoglobin fractions as reference standards including hemoglobin A1c and others (HbA1c, gly Hb, glyHbA0, HbA1a, b). Exocell offers other hemoglobin fractions as well, notably deglycated hemoglobin (deHb, deHbA0) and hemoglobin A0 (HbA0).

Glycated albumin reflects the average blood sugar during the preceding 2-3 week period. It has been shown to have direct adverse effects on kidney cell function. Periodic measurement of glycated albumin may be especially helpful in identifying risk for kidney disease. Glycated LDL reflects the average blood glucose level during the preceding 4-7 days, and has import for cardiac risk. Glycaben and Glycacor are diagnostic kits for the mesurement of glycated albumin and glycated LDL, respectively.

Animal models are very useful for studying diabetes and diabetic complications. Nephrat and Albuwell M are designed to measure albumin in rodent urine. They are the gold standards for measuring this analyte in rodent models to assess kidney dysfunction and to evaluate response to experimental drugs. Collagen IV M has been used successfully to measure urinary type IV collagen in both mouse and rat models, and is useful in determining the development of kidney damage in diabetic animals. Again, the Creatinine Companion serves to measure urinary creatinine, and to normalize urinary albumin and collagen IV against a secondary analyte. Glyco-Albumin M and Glyco-Albumin R are new products designed to measure glycated albumin in mouse and rat serum samples, respectively.

Exocell is now working on tests for in-office and in-home measurement of glycated hemoglobin and glycated albumin.

Glycadia now has a new website, www.glycadia.com.

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Michael H. Cohen, Esq.; 468 North Camden Dr. | Beverly Hills, California 90210 | 310-844-3173