Venient CDx Ovarian Cancer Basic

Test description
Venient CDx Ovarian Basic is a disruptive and non-invasive confirmatory diagnostic test for ovarian cancer diagnosis. It is based on a routine blood and urine analysis and powered by both public and proprietary machine learning (ML) algorithms. Our confirmatory diagnostic tool is able to accurately confirm or rule out previous suspicious imaging findings in order to reduce turnaround time (TAT) for diagnosis confirmation as well as the number of unnecessary tissue biopsies. Additionally, the Venient CDx Ovarian Basic is also able to discriminate between serous and mucinous epithelial ovarian cancer, even in early stages when treatment is most likely to be successful.

United States Preventative Services Task Force (USPSTF) diagnostic confirmation recommendations 
Currently, there are no USPSTF (United States Preventative Services Task Force) diagnostic confirmation recommendations for ovarian cancer. However, Kience Inc. recommends our Laboratory Developed Test (LDT) to target: 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. 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 CDx Ovarian Basic.

Intended Use
The intended use population for Venient CDx Ovarian Basic is: 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 —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—.