Venient Sx Ovarian Cancer Basic

Test Description

Venient Sx Ovarian Cancer Basic is a disruptive, non-invasive screening test for ovarian cancer screening and early detection.

It is based on a routine blood and urine analysis and is powered by both proprietary machine learning and public algorithms, and provides highly accurate broad diagnostic information, including the likelihood of ovarian cancer. It is also able to distinguish between serous and mucinous epithelial― even in early stages, before symptoms appear and when treatment is most likely to be successful.

Its is based on the risk of ovarian malignancy algorithm (ROMA) and other calculations. It also include the determinations of the hepatic enzymes and other analytes that can detect and discard false positives.

Screening recommendations

The United States Preventative Services Task Force (USPSTF) 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 the Venient Sx Ovarian Cancer 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. 

Intended Use

The target population for Venient Sx Ovarian Cancer 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 —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—.