Lab to Specialize in Biomarker Diagnostics for Gynecologic Cancers

These labs will also serve as an education and resource hub for health care professionals and women facing surgery for ovarian masses that are potentially cancer and related gynecologic conditions. Initially, the lab will process diagnostic tests and clinical decision aids for women's health in ovarian cancer, and then will expand to other gynecologic conditions.

ASPiRA specializes in OVA1, a highly sensitive, US Food and Drug Administration (FDA; Silver Spring, MD, USA)-cleared clinical decision support diagnostic tool used by obstetricians/gynecologists in the management of patients with suspicious adnexal masses prior to first surgery. OVA1 measures the levels of five protein biomarkers found in the blood––B2 Microglobulin; CA 125II; Apoliprotein; Prealbumin; and Transferrin––and then uses proprietary software called OvaCalc to calculate a single risk score for malignancy. Across two studies, OVA1 showed 96% sensitivity and 95-98% negative predictive value (NPV) for adnexal malignancy, when combined with routine clinical assessment.

OVA1 validation has been published in five clinical research articles from more than 1,000 surgeries and more than 250 malignancies, in two prospective pivotal trials. Across the two studies, OVA1 showed 96% sensitivity and 95-98% negative predictive value (NPV) for adnexal malignancy, when combined with routine clinical assessment. Detection of ovarian cancer included epithelial, non-epithelial, and early-stage malignancies. This evidence suggests that OVA1 may promote more sensitive identification of ovarian cancers among women undergoing surgery for an adnexal mass. Once identified, patients are referred or consulted with a gynecologic oncologist, supporting best practices in ovarian cancer care.

The key motivation for creation of ASPiRA LABS was the current diagnostic and treatment picture for gynecological cancers in the United States. More than 90,000 women in the United States are diagnosed with a gynecological cancer each year, and 28,000 women die from these cancers every year. Ovarian cancer, in particular, has not seen notable improvements in mortality rate reduction despite advancements in many other cancers. Almost 22,000 women are diagnosed with ovarian cancer in the United States annually, and more than 14,000 die each year, making it the deadliest of all gynecologic cancers.

Medical associations recommend that women with suspected ovarian cancer be referred to a gynecologic oncologist for surgery for the best potential outcomes. Not receiving care adherent to these guidelines is a predictor of inferior survival rates. Yet, only an estimated one-third of women who have a malignant tumor are operated on by a gynecologic oncologist for the initial removal of cancer. African-American women, women on Medicare, and those who have lower socioeconomic status are even more likely to receive suboptimal care.

James LaFrance, chairman, president, and chief executive officer (CEO) of Vermillion, commented, "We know that disparities exist—particularly around accessing what has been recognized in the health care industry as the best treatment pathway when ovarian cancer is suspected. We felt it was important to build our own lab to create a dedicated diagnostic and education resource for this area of critical need." He added, "Through ASPiRA LABS, we are focused on shifting health care delivery to a model that values the most informed decisions to improve outcomes for women. Working together with our partners we will expand access to proven diagnostics to address health disparities and get more women to the right care sooner."

Related Links:
ASPiRA LABS
Vermillion
US Food and Drug Administration