Second-Generation Assay More Sensitive, Less Specific in Ovarian-Cancer Detection

By Reuters Staff

July 30, 2019

NEW YORK (Reuters Health) - The MIA2G multivariate index assay (Overa, Vermillion) with subsequent risk stratification is a more sensitive method of predicting ovarian cancer than is ROMA, a currently used triage algorithm, according to a company-funded study.

But it is also less specific, researchers report in Advanced Therapeutics, online June 24.

"These findings advance our ability to detect ovarian malignancy and provide clinicians with reliable tools to screen adnexal masses," Dr. Lee Shulman of the Feinberg School of Medicine, in Chicago, said in a statement.

The Risk of Ovarian Malignancy Assay (ROMA) combines the tumor markers cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) using two formulae, allowing for the menopausal status of each patient.

The Overa (MIA2G) measures the levels of five blood biomarkers, including CA125 and HE4, and then uses a second-generation OvaCalc algorithm to stratify risk.

From data drawn from participants in previous clinical trials, the researchers identified 245 who were diagnosed with a malignancy, most commonly ovarian cancer (67.8%).

Evaluation of these subjects' serum samples showed a sensitivity of 71.0% for CA125, 79.2% for ROMA and 91.0% for MIA2G. Corresponding specificities were 89.7%, 78.9% and 65.5%.

MIA2G had the lowest rate of false negatives, 2.2% overall, and the highest false-positive rate, at 26.0%. ROMA was significantly more likely to misclassify early cases than was MIA2G, the researchers report.

Dr. Shulman stated, "The ability to better detect disease while reducing the number of missed cancer cases, is critical for improving outcomes for women with adnexal masses."

Dr. Shulman did not respond to request for comments.

The study was funded by Aspira Labs/Vermillion with whom Dr. Shulman has relationships. The other authors have been or currently are employed by these companies.


Adv Ther 2019.