Venient Fx Venient Fx Hormonal Balance and Reproductive Function Comprehensive - Female

Test Description

Venient Fx Hormonal Balance and Reproductive Function Comprehensive (Female) is a disruptive, non-invasive test that provides comprehensive information on female hormonal balance and reproductive function. 

It is based on a routine blood analysis and is powered by both proprietary machine learning and public algorithms, and provides highly accurate primary diagnostic information, including the likelihood of suffering from different types of gynecological diseases —e.g. polycystic ovary syndrome (PCOS), endometriosis—.

It is based on the determination of the FSH/LH ratio and the free androgen index (FAI). In addition, it also includes the determination of other important reproductive hormones and other analytes.

It is an Evidence Based Laboratory Medicine (EBML) test developed not only in accordance with the guidelines of the American College of Obstetricians and Gynecologists (ACOG), but also incorporating the latest scientific findings. 

Screening recommendations

The United States Preventative Services Task Force (USPSTF) recommends screening women aged 21 to 65 years with cytology (Pap smear) every 3 years or, for women aged 30 to 65 years who wish to extend the screening interval, screening with a combination cytology and human papillomavirus test every 5 years.

However, Kience Inc. recommends the Venient Fx Hormonal Balance and Reproductive Function Comprehensive (Female) test to treat patients with the following symptoms, signs or suspicions of disease: irregular or no periods, severe pain during periods, difficulty becoming pregnant, weight gain, hair loss, extra body hair, polycystic ovary syndrome (PCOS) and endometriosis.

Intended Use

The target population for Venient Fx Hormonal Balance and Reproductive Function Comprehensive (Female) is patients with clinically suspected: irregular or no periods at all, severe pain during periods, difficulty becoming pregnant, weight gain, hair loss, extra body hair (male pattern baldness or thinning hair), excessive bleeding, polycystic ovary syndrome (PCOS) and endometriosis.

Sample Clinical Vignette

A 30-year-old female visits her gynecologist, complaining about irregular period cycles, severe pain during periods, and a constant heaviness in her lower abdomen for 1 year. She also complains about dysmenorrhea (severe menstrual cramps during periods), that are the cause of the severe pain. Serum is submitted to assess her hormonal balance and reproductive health, to see whether she is suffering of endometriosis.

Required Laboratory Determinations

Hemogram —Red Blood Cell Count, Hemoglobin, Hematocrit—; Red Blood Cell Indices —Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red Cell Blood Distribution Width (RDW)—; Leukocyte Count —Total Leukocytes Absolute, Total Neutrophil Absolute, Total Lymphocyte Absolute, Total Monocyte Absolute, Total Eosinophil Absolute, Total Basophil Absolute—; Platelets —Total Platelet Count, Mean Platelet Volume (MPV), Platelet Distribution Width (PDW)—; Serum Proteins —High Sensitivity C-Reactive Protein (hs-CRP)—; Serum Hormones —Anti Müllerian Hormone (AMH), Androstenedione, Cortisol, Dehydroepiandrosterone Sulfate (DHEA-S), Estradiol, Follicle Stimulating Hormone (FSH), Insulin, Luteinizing Hormone (LH), Procalcitonin, Progesterone, Prolactin, Sex Hormone-Binding Globulin (SHBG), Testosterone—; Other Serum Analytes —Glucose—.