Venient Fx Pancreatic Endocrine Function Comprehensive
Test Description
Venient Cx Pancreatic Endocrine Function Comprehensive is a groundbreaking blood and urine based screening test that provides extensive information about pancreatic endocrine function.
This is an Evidence-Based Laboratory Medicine (EBLM) test developed not only in compliance with the American Association of Clinical Endocrinology (AACE) and the American Diabetes Association (ADA) guidelines, but also incorporating the latest scientific findings. Thanks to our proprietary machine learning (ML) algorithms, this test is able to accurately detect insulin resistance (IR), prediabetes, and diabetes mellitus (DM), and delivers comprehensive information. It also calculates the 7.5-year risk (%) of developing diabetes mellitus (DM).
United States Preventative Services Task Force (USPSTF) screening recommendations
The USPSTF recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who have overweight or obesity. However, Kience Inc. recommends our laboratory-developed test (LDT) Venient Cx Pancreatic Endocrine Function Comprehensive to address patients with clinical suspicion of: type 1 diabetes mellitus, type 2 diabetes mellitus, overweight, obesity, sedentary lifestyle, abdominal obesity, metabolic syndrome, Cushing's syndrome, long-term systemic corticosteroid exposure, or gestational diabetes.
Intended Use
The intended population for Venient Cx Pancreatic Endocrine Function Comprehensive test are patients with clinical suspicion of: type 1 diabetes mellitus, type 2 diabetes mellitus, autoimmune diabetes, obesity, sedentary lifestyle, abdominal obesity, metabolic syndrome, Cushing's syndrome, long-term systemic corticosteroid exposure or gestational diabetes.
Sample Clinical Vignette
A 50-year-old female with sedentary lifestyle and dyslipidemia presented for medical evaluation after a 3-month history of polyuria, polydipsia and polyphagia. She explained progressive blurred vision, numbness in feet and urinary tract infections. Physical exam revealed abdominal obesity, high blood pressure (165/95 mmHg) and altered vibrotactile sensitivity of lower limbs. Serum and urine are submitted to determine the risk of glucose-related diseases, such as diabetes and insulin resistance.
Required Laboratory Determinations
Serum Sterols & Fatty Acids —Total Cholesterol, HDL-Cholesterol, Cholesterol non-HDL, LDL-Cholesterol, VLDL-Cholesterol, Triglycerides—; Serum Hormones —Insulin—; Other Serum Analytes —Serum Creatinine, Glucose, Glycated Hemoglobin (HbA1c)—; Other Urine Analytes —Urine Albumin, Urine Creatinine—; Urinalysis –Density, pH, White Blood Cells, Nitrites, Protein, Glucose, Ketones, Urobilinogen, Urobilin, Red Blood Cells, Urine Sediment—.