HE4 With ROMA Index

HE4 With ROMA Index is a diagnostic test to assess the risk of epithelial ovarian cancer in women. It measures the level of Human Epididymis Protein 4 (HE4) and CA 125 in combination with the Risk of Ovarian Malignancy Algorithm (ROMA) index, providing valuable information for the early detection and management of ovarian cancer. 

Ovarian cancer is one of the most common gynecological cancers in women. In 2024, the National Cancer Institute estimates that there will be approximately 19,680 new cases of ovarian cancer diagnosed*. Detecting ovarian cancer early can be challenging due to the absence of routine screening, non-specific symptoms (even in advanced stages), and the limited specificity of imaging tests. This often leads to delays in diagnosis until the cancer has progressed significantly. This highlights the ongoing importance of early detection and advanced diagnostic tests like the HE4 With ROMA Index. 

HE4 With ROMA Index test combines the measurement of HE4 (Human epididymis protein 4), CA 125 (cancer antigen 125), and menopausal status to estimate the risk of ovarian cancer. HE4 is a protein that is produced by cells in the ovaries and the lining of the respiratory tract. It is often elevated in women with epithelial ovarian cancer and can be used as a biomarker for the disease. CA 125 is another protein that is often elevated in women with ovarian cancer, but it can also be elevated in physiological or pathological conditions in women, such as menstruation, pregnancy, endometriosis, uterine fibroids, and pelvic inflammatory disease. The ROMA index is a mathematical formula that combines the levels of HE4 and CA 125 in the blood to estimate the risk of ovarian cancer. This mathematical calculator incorporates menopausal status to assign women presenting with an adnexal mass into a high-risk or low-risk group for finding ovarian cancer. 

The ROMA index takes into account a woman’s age and menopausal status, determined by the lack of menstruation or clinical signs of menopause for at least six months. The combination of these tests enhances the accuracy in predicting the presence of ovarian cancer, particularly in the early stages. Also, it offers a more nuanced assessment of ovarian cancer risk, particularly distinguishing between malignant (cancerous) and benign (non-cancerous)  ovarian masses. 

HE4 With ROMA Index test is recommended for women who are above 18 years of age, have an adnexal mass for which surgery is planned, and who have not yet been referred to a doctor who specializes in diagnosing and treating cancer (oncologist). 

The HE4 With ROMA Index test is crucial but it is not intended as a screening or standalone diagnostic test. Other conditions can also affect HE4 and CA 125 levels. This test should be used in combination with other diagnostic tools like imaging, biopsies, etc., and clinical evaluation for confirmatory diagnosis. 

No special preparation is required for this test. You can eat and drink as per your routine. However, it is important to provide a brief clinical history or doctor's prescription at the time of sample collection. Additionally, provide the date of your last menstrual period (LMP) or indicate the menopausal status of the patient. Inform your doctor about any medications or supplements you may be taking as these could impact the test results. 

HE4 With ROMA Index test holds immense significance for doctors. It helps them classify patients based on their risk for ovarian cancer and decide on the next steps for testing and treatment. 

Don't self-medicate at home solely based on the test results and always consult a doctor for proper understanding of your health needs. Your doctor can interpret the results in the context of your overall health and medical history, ensuring that any recommendations or treatments are safe and appropriate for you. 

Important considerations regarding the use of ROMA in ovarian cancer: 

• The ROMA calculator tool is not a definite indicator of cancer presence or absence.
• It is not meant for general cancer screening.
• ROMA helps assess the risk of ovarian cancer in those women who have adnexal mass and will undergo surgery.
• It is not recommended for monitoring mucinous or germ-cell ovarian cancer.
• The test results should be considered alongside symptoms and medical history, and a low-risk ROMA result should not rule out an oncologist referral if the initial cancer risk is high.
• ROMA has not been validated for patients previously treated for cancer, those undergoing chemotherapy, or those under 18 years old.