Invention Details

There are currently 529 million people living with diabetes mellitus. 12% of global health expenditure is spent on diabetes. Approximately 46% of people living with diabetes are doing so without a full and proper diagnosis.  This low to no maintenance approach to disease management is not only dangerous but also significantly contributes to health care costs both in the short and long term.

INVENTOR

Inventor Dr. Mehmet Ali SOYLEMEZ discovered for the first time, the utility of the biomarker ‘’PROCALCITONIN’’ in DIABETES MELLITUS and DIABETIC FOOT SYNDROME. More than 40 peer reviewed publications have followed, substantiating PROCALCITONIN as one of the most promising biomarker tools for DIABETES MELLITUS of healthcare. This Invention also receives WORLD’s Prestigious Best Prognostic Diabetic Biomarker Development Company 2023 – ‘ AwardGHP– GLOBAL The HEALTHCARE and PHARMACEUTICAL Award Winner in 2023STAFFORDSHIRE, UNITED KINGDOM.   https://www.ghp-news.com/winners/soylemez-investment/

PATENT RIGHTS OF THE INVENTION

Dr. Mehmet Ali SÖYLEMEZ is the patent right owner of the invention; “Diagnosis of Pancreatic Diabetes in Patients with Normal Blood Leucocyte Counts Using Procalcitonin”. My patent right is registered with the European Patent Office with the registration number EP2626704 B1. My patent is also under protection within 3 national registry including United Kingdom (Patent No: EP 2626704), and Turkey (Patent No: 2016/01937).

CLAIM OF THE INVENTION

This invention relates to a method for diagnosis and/or diabetic complications and/or risk assessment of pancreatic diabetes.

EP 2626704 Claim 1: Procalcitonin immunoassay for in vitro diagnosis of a patient having pancreatic Diabetes Mellitus and/or diabetic foot syndrome, comprising: determining the level of procalcitonin in a sample selected from the group consisting of a blood sample, a serum sample and a plasma sample obtained from the patient with blood leucocyte counts within normal value ranges and comparing the level of procalcitonin to a threshold level, whereby, when the level of procalcitonin exceeds said threshold level, the patient is diagnosed with pancreatic Diabetes mellitus and/or Diabetic Foot Syndrome.

DETAILS OF THE INVENTION

I have invented a novel diabetic biomarker which is more effective screening of Diabetes Mellitus and its complications compared to its rival HgbA1c. This invention (‘’procalcitonin’’) is more useful than HgbA1c. Because the HgbA1c shows a period of 3-months diabetic complications damage while my invention procalcitonin shows 24-hour diabetic complications damage. So, Diabetes Mellitus and diabetic complications can be treated faster and more successfully.

HgbA1c is a glycated protein. It does not work in anemia, pregnancy, hyperthyroidism, and other states. The diabetic complications are not correlated to the HgbA1c status, and differs for each person. My invention procalcitonin is not a glycated protein. It is an inflammatory biomarker which shows chronic low-grade inflammation of the Diabetes Mellitus and its complications. This invention works as a prognostic biomarker for all of the diabetic patients.

THE VALUE-PROPOSITION OF THIS BIOMARKER

The value-proposition of my biomarker: For initial assessment in the early phase of diabetes to identify patients with particular risks that require more specific management of complications.

These patients would not be detected with current diagnostics. This invention procalcitonin shows not only the late phase of diabetic complications, but also the early phase (Pre-diabetic phase) of Diabetes Mellitus.

In this respect, using ‘’procalcitonin’’ for diagnosis of Diabetes Mellitus and diabetic foot syndrome is subject to this patent’s rights. Furthermore, diagnosis of infection levels in Diabetic Foot Syndrome with using procalcitonin is under the protection of this patent’s rights.

This patent can use for daily complication risk assessment of all diabetic patients and save lifes, suffering from the diabetic complications at all around the world. it is more important method than Hemoglobin A1c. Because all diabetic complications can monitorizing using one marker (procalcitonin) in 24 hours period. New technology of insulin pump system or traditional diabetes mellitus therapy need this invention for proper diabetic complication (retinopathy, nephropathy,neuropathy) treatment. 

Follow up Tool to Monitor Progression

As a potential tool for patients to enable them to understand how their lifestyle and drug adherence translate to impact on future complications.