Vermillion, Inc., a multivariate diagnostics company dedicated to studying gynecologic cancers and women’s health, will present its new CLIA-certified reference laboratory, the Texas-based ASPiRA LABS, at the American Association for Clinical Chemistry’s annual (AACC) meeting, to be held on July 31st. ASPiRA LABS provides expert diagnostic services, including OVA1® as well as Longitudinal CA 125 testing, supporting clinical decisions, and advancing personalized treatment plans.
Herbert Fritsche, Jr., Ph.D., Laboratory Director of ASPiRA LABS, and Michael Randell, M.D., FACOG, of Northside Hospital in Atlanta, one of the largest comprehensive women’s healthcare facilities in the country, will lead the presentation. They will be sharing relevant information on ASPiRA LABS’ services, and on the clinical relevance of incorporating OVA1 into the management of patients with ovarian adnexal masses with surgery indication. The recent launch of ASPiRA LABS seeks to deliver clear, intuitive, and timely results focusing on providing a personalized reference laboratory experience, including readily accessible expert consultations to physicians and laboratories.
“Our lab delivers superior service and clear results that help gynecologists select the optimum care path by identifying patients with a high risk of ovarian malignancy,” said Dr. Fritsche, former Chief of Clinical Chemistry at M.D. Anderson Cancer Center. “ASPiRA LABS strengthens our ability to improve OVA1 by managing all aspects of service from sample collection to a single patient identifier to facilitate future testing in the continuum of care.”
Aside from OVA1, ASPiRA LABS offers Longitudinal CA 125 testing. The CA 125 baseline level is obtained from OVA1 before initial surgery and ovarian cancer diagnosis. If ordered as part of post-surgical monitoring by the gynecologic oncologist, ASPiRA LABS provides a multi-point CA 125 graph in which the baseline is compared to a newly measured CA 125 result. According to FDA-cleared use of CA 125, this report may help health care professionals uncover residual disease or ovarian cancer recurrence.
“I’m pleased to be speaking on behalf of OVA1, a test I believe to be the best tool for detecting ovarian malignancies and aiding in the selection of the proper surgery by the proper specialist and as a result will help provide patients with the best possible care,” said Dr. Randell.
The current diagnostic and treatment panorama for ovarian cancer was a major motivating factor for creating ASPiRA LABS. Despite advancements in many other cancers, mortality rate reduction has not improved considerably in ovarian cancer. In the United States, nearly 22,000 women are diagnosed with ovarian cancer each year, of which more than 14,000 die, making ovarian cancer the deadliest of gynecologic cancers. ASPiRA LABS sponsors the Ovarian Cancer National Alliance (OCNA) and constitutes an educational resource axis not only for health care professionals but also for women facing surgery for potentially malignant ovarian masses.
ASPiRA LABS grounds its specialized services in evidence-based medicine, while providing access to novel biomarker diagnostic tools designed to help healthcare professionals offer the most precise diagnoses and treatment guidance for their patients.
Vermillion Inc. focuses on discovering, developing, and commercializing novel high-value diagnostic tests to help physicians diagnose, treat, and improve outcomes for patients. Along with its prestigious scientific collaborators, Vermillion has developed diagnostic programs in gynecologic oncology and women’s health.
OVA1®, the company’s lead diagnostic, is a pre-surgical blood test that assesses ovarian tumors for malignancy using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics.