Diagnostic test for diabetic kidney disease receives EU approval

02/11/2020 03:51 PM
Bio Preventive Medicine Chairperson Tseng Tzu-ling. Photo courtesy of Bio Preventive Medicine.
Bio Preventive Medicine Chairperson Tseng Tzu-ling. Photo courtesy of Bio Preventive Medicine.

Taipei, Feb. 11 (CNA) A clinical test designed by a Taiwanese biotech company that predicts a patient's risk of diabetic kidney disease has been approved for sale in the European Union, the company said Tuesday.

The test, called DNlite-IVD103, has obtained a CE Marking, indicating that it complied with EU safety requirements and can be sold on the EU market, according to its developer Bio Preventive Medicine Corp.

The company said it is now applying for permission for the product to be sold in Malaysia and Singapore as well.

The DNlite-IVD103 is the first in-vitro diagnostic product (IVD) that can accurately detect the risk of diabetic kidney disease, according to the company.

Screenshot of Bio Preventive Medicine Corp.
Screenshot of Bio Preventive Medicine Corp.'s website

Diabetic kidney disease, also known as diabetic nephropathy (DN), is the chronic loss of kidney function in people with diabetes and a leading cause of end-stage kidney disease.

In the United States, it affects around a quarter of adults with diabetes, studies have shown.

The disease is currently diagnosed by measuring whether there are abnormal amounts of the protein albumin in a patient's urine.

That test, however, can only diagnose patients after their kidney functions have deteriorated to a certain degree, which means patients often miss opportunities for early treatment, according to Bio Preventive Medicine.

The DNlite-IVD103, which measures biomarkers instead of albumin in a patient's urine, overcomes this problem and can accurately predict a patient's kidney function in the following two years, the company said.

By informing patients that they are at risk of the disease before their kidney functions begin to worsen, they can receive suitable treatment in a timely way, according to the company.

(By Han Ting-ting and Chiang Yi-ching)

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