On December 17, 2019 Vermillion, Inc. (Nasdaq: VRML), a bioanalytical-based women’s health company focused on gynecologic disease and Einstein Medical Center, the largest independent academic medical center in Philadelphia, reported the first patient enrolled in a study that compares OVA1 to CA125 assay for detection of ovarian cancer risk in African American women (Press release, Vermillion, DEC 17, 2019, View Source [SID1234552442]).

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The study will enroll over 200 prospective African American women with adnexal masses. Ovarian cancer risk will be assessed by both CA125 and OVA1 Plus. The primary objective is to determine the differences in sensitivity and accuracy of cancer risk detection between the testing methodologies. The study is to be expanded to women of varying ethnic backgrounds as well.

"African American women have lower incidence of ovarian cancer than Caucasian women, yet a higher all-cause mortality rate," said Lead Investigator Kate Stampler, D.O., Department of Obstetrics and Gynecology at Einstein Medical Center Philadelphia. "Recent evidence demonstrates that they also have lower levels of CA125 that could lead to underdiagnosis."

Recently published studies demonstrate that OVA1 has greater sensitivity in detecting ovarian cancer across multiple ethnicities and technologies including CA125 and ROMA:

OVA1 in African American women is 2.38-times more sensitive than CA125: 79.2% v 33.3%1
OVA1 in African American women is 1.45-times more sensitive than ROMA: 79.1% v 54.5%2
OVA1 in Caucasian women is more sensitive than CA125: 93.2% v 74.4%1
OVA1 in Caucasian women is more sensitive than ROMA: 93.2% v 82.9%2
"This study should confirm that OVA1 provides more sensitive risk detection in African American women. It may also define differences in sensitivity amongst various ethnicities and races," said Charles Dunton, MD, Global Medical Director, Vermillion. "This study can help address the disparities in diagnosis and outcomes of ovarian cancer in African American women."

OVA1 is an FDA-cleared and ACOG-endorsed blood test offered via ASPiRA Labs. OVA1 proactively assesses the risk of ovarian malignancy from a simple blood test, as a pre-operative biopsy is not medically appropriate. Clinically, OVA1 objectively guides the patient treatment care plan for low-risk and high-risk pelvic mass patients.