Venient Sx Ovarian Cancer Basic

Test Description
Venient Sx Ovarian Basic is a disruptive and non-invasive screening test for ovarian cancer screening and early detection. It is based on a routine blood and urine analysis and powered by both public and proprietary machine learning (ML) algorithms. Our diagnostic tool is able to accurately detect ovarian cancer ―distinguishing between serous and mucinous epithelial― even in early stages, before symptoms appear and when treatment is most likely to be successful.

United States Preventative Services Task Force (USPSTF) screening recommendations
The USPSTF (United States Preventative Services Task Force) recommends against screening for ovarian cancer in asymptomatic women, with current available screening methods, due to potential harms, including many false-positive results, which can lead to unnecessary surgical interventions in women who do not have cancer. However, Kience Inc. recommends our laboratory-developed test (LDT) Venient Sx Ovarian Basic to target: women at average risk of ovarian cancer, aged 40 onwards, annually; women at high risk of ovarian cancer, aged 30 onwards, annually. This recommendation is based on the following facts: extensive scientific data supports that early cancer detection saves lives, the non-invasiveness and the wide affordability of Venient Sx Ovarian Basic.

Intended Use
The intended use population for Venient Sx Ovarian Basic is females at average risk of ovarian cancer, aged 40 onwards, annually and females at high risk of ovarian cancer, aged 30 onwards, on an annually basis.

Sample Clinical Vignette
A 60-year-old nulliparous female, with sedentary lifestyle and overweight, current smoker with a cumulative dose of 20 pack/year, and actually on hormone replacement therapy, complains with her healthcare provider about a new monthly vaginal bleeding and bloating. On physical exam, there is some ascites and pain in her lower quadrant. Serum and urine are submitted to detect a possible ovarian cancer.

Required Laboratory Determinations
Serum Hepatic Enzymes —Amylase Total, Amylase Pancreatic, Creatine Kinase, Lipase, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH)—; Serum Tumor Markers —Carbohydrate Antigen 19.9 (CA 19.9), Carbohydrate Antigen 125 (CA 125), Carcinoembryonic Antigen (CEA), Human Epididymis Protein 4 (HE4)—; Other Serum Analytes —Bilirubin Total, Bilirubin Direct, Bilirubin Indirect, Serum Creatinine—; and Other Urine Analytes —Urine Albumin, Urine Creatinine—.