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ROMA™ (Risk of Ovarian Malignancy Algorithm) 

Nov 16, 2019


CA125, HE4 Ovarian CA Monitoring, and Risk of Ovarian Malignancy calculation

Reference Range(s)

ROMA Premenopausal 1.31
ROMA Postmenopausal <2.77
CA125 <35 U/mL
HE4, Ovarian CA Monitoring
Female Premenopausal ≤70 pmol/L
Female Postmenopausal 1.31

  • Ovarian cancer is one of the most common malignant tumors in the female reproductive system, it has a very high fatality rate because it is too insidious to be identified early.
  • In approximately, 70% of all cases of ovarian cancer, the disease is not diagnosed before reaching an advanced stage.
  • The 5-year survival rate associated with ovarian cancer is <30%
  • Over 90% of all cases of ovarian masses detected in premenopausal and ≤60% in postmenopausal women, are benign.
  • The early diagnosis of ovarian malignant tumor becomes a key factor in improving the survival rate of patients.
  • Carbohydrate antigen 125 (CA125) is a traditional marker for ovarian cancer screening.
  • Serum human epididymis (HE4) is also a common indicator for detecting ovarian cancer.
  • Over the past few decades, with the rapid development of statistical technology, the use of mathematical models makes it possible to combine multiple markers to detect the disease.
  • The combination of multiple tumor markers can improve the diagnostic sensitivity and not reduce the diagnostic specificity.
  • Therefore, the emergence of the risk of ovarian malignancy algorithm (ROMA) model caused a lot of attention.
  • The Risk of Ovarian Malignancy Algorithm (ROMA™) test is intended to aid in assessing the risk of ovarian cancer in women with a pelvic mass based on the patient's HE4 and CA125 levels and their menopausal status.
  • Women with ROMA™ levels above the cutoff have an increased risk of ovarian cancer.
  • The early clinical symptoms of ovarian cancer are not obvious so as to make it easy to transfer and spread, leading to a high death rate. Therefore, it is diagnosed in the middle and late stages thus missing the best treatment opportunity and showing poor treatment effect.
  • There may be many cases of elevated CA125 and its diagnostic sensitivity is relatively low, especially when it comes to the early diagnosis of ovarian cancer which is not ideal, just vulnerable to the impact of benign diseases.

The CA125 and HE4 tests are performed at Modern Wellness labs using the Abbott ARCHITECT unit. The values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity.