Venient CDx Ovarian Cancer Basic

Test description

Venient CDx Ovarian Cancer Basic is a disruptive, non-invasive confirmatory diagnostic test for ovarian cancer diagnosis.

It is based on a routine blood and urine analysis and is powered by both public and proprietary machine learning (ML) algorithms, and provides highly accurate broad diagnostic information, including the confirmation of ovarian cancer from previous suspicious findings. 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 includes the determinations of the hepatic enzymes and other analytes that can detect and discard false positives.

Diagnostic confirmation recommendations 

The United States Preventative Services Task Force (USPSTF) has no recommendations for diagnostic confirmation of ovarian cancer.

However, Kience Inc. recommends the Venient CDx Ovarian Cancer Basic to target patients with symptoms, signs or suspicion of disease: women with inconclusive results in IOTA’s Simple Rules test and women with adnexal masses suspicious of ovarian cancer that must undergo a laparotomy or a laparoscopy surgery to confirm or discard malignancy. 

Intended Use

The target population for the Venient CDx Ovarian Cancer Basic test is patients who present with clinical findings of: women with inconclusive results in IOTA’s Simple Rules test and women with adnexal masses suspicious of Ovarian Cancer that must undergo a laparotomy or a laparoscopy surgery to confirm or discard malignancy.

Sample Clinical Vignette

A 60-year-old female, with sedentary lifestyle and overweight, current smoker with a cumulative dose of 20 pack/year, and actually on hormone replacement therapy, visits her gynecologist because of a suspicious adnexal mass found in a previous ovarian image testing. The patient presents 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—.