Austin-based Vermillion, recently announced that the company has launched a new laboratory called ASPiRA LABS, which will work towards creating biomarker-based technologies in order to help doctors manage gynecologic cancers in their patients.
The lab’s service offerings are built around a new biomarker-based diagnostic algorithm, which will serve as the engine for powering the lab’s diagnostic processing and results, as well as serving the healthcare community by offering valuable resources for doctors, nurses, and patients who are either facing surgery for potential gynecologic cancers, or who will be participating in surgery or ongoing treatment for gynecologic cancer patients. The initial goal of the new lab, however, will be to offer diagnostic processing services in order to aid doctors in making accurate diagnoses for ovarian cancer, with diagnostic services for other gynecologic conditions to soon follow.
The decision to launch ASPiRA LABS, according to the company, was based on the realization that there are major unmet needs in the diagnosis and treatment of gynecologic cancers among the U.S. patient population. In spite of the fact that over 90,000 women throughout the U.S. receive a gynecological cancer diagnosis annually, 28,000 women die yearly from the disease, and that the mortality rate among ovarian cancer has note declined commensurately with other cancers, Vermillion feels that the healthcare industry has not reacted swiftly enough to address the situation. With ovarial cancer alone, close to 22,000 ovarian cancer diagnoses each year in the United States alone, 14,000 of which die — by far the most deadly gynecologic cancer.
Where the healthcare industry appears to be lacking in addressing the diagnosis and early treatment of ovarian cancer — particularly in referring patients early to gynecologic oncologists for exploratory surgeries among diagnosed patients — James LaFrance, the chairman, president, and CEO at Vermillion, believes that ASPiRA LABS is well positioned to improve early diagnoses and treatment paths in ovarian cancer through the use of the company’s proven OVA1 diagnostic. “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,” he said, adding, “Working together with our partners we will expand access to proven diagnostics to address health disparities and get more women to right care sooner.
As an FDA-approved diagnostic tool for obstetricians and gynecologists to make the best treatment decisions for management of patients’ who are scheduled for surgery on suspicious adnexal masses, OVA1 will be used by the lab as a front-line diagnostic tool for measuring 5 protein biomarkers levels in the bloodstream that are key to determining malignancy rates – B2 Microglobulin; CA 125II; Apoliprotein; Prealbumin; and Transferrin. Together with OvaCalc — a proprietary software solution that works in tandem with OVA1 — the lab will be capable of calculating a reliable risk score for tumor malignancy as it relates to ovarian cancer.
OVA1, however, will not be the only diagnostic tool utilized by ASPiRA LABS. Physicians will also have access to the lab’s longitudinal CA 125II testing. After establishing a CA 125II baseline level from the results of OVA1 testing, this test will be able to be administers before ovarian cancer surgery and diagnosis. This baseline will be particularly helpful to gynecologic oncologists for monitoring patients after surgery, as the test will provide physicians with a two-point CA 125II graph that will allow them to compare the baseline established in the test to post-surgery CA 125II measurements. Also an FDA-cleared test, CA 125II can asset doctors in detecting any residual disease as well as the recurrence of the disease.
In addition to providing these valuable tests for ovarian cancer, ASPiRA LABS also plans to offer educational resources to help train healthcare professionals in properly using these tools to render the most accurate evidence-based diagnoses and health decisions, including a web-based portal for offering continuing education for both patients and health professionals. There will also be a service offering provided through the portal, making test result consultations available for physicians, nurses, and other assistants will be offered as well.