Vermillion, a multivariate diagnostics company focused on gynecologic cancers and women’s health, has launched a new business unit called Aspira Labs, which will specialize in applying the latest biomarker-based technologies to address critical needs in the management of gynecologic cancers.

A national lab based in Austin, Tex, Aspira will provide expert diagnostic processing and results using a state-of-the-art biomarker-based diagnostic algorithm to inform clinical decision-making and advance personalized treatment plans. Aspira will also serve as an education and resource hub for healthcare professionals and women facing surgery for ovarian masses that are potentially cancerous, and for 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 with high unmet need.

A key motivating factor for the creation of the lab is the current diagnostic and treatment landscape for gynecologic cancers. Each year, more than 90,000 women in the United States are diagnosed with a gynecological cancer, and 28,000 women die from such cancers.1 Despite advances against many other cancers, ovarian cancer has not seen notable improvements in mortality rate reduction.2 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.3

Leading 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.4 African-American women, women on Medicare, and those who have lower socioeconomic status are even more likely to receive sub-optimal care.5

LaFrance

Jim LaFrance

“We know that disparities exist—particularly around accessing what has been recognized in the healthcare 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,” said James LaFrance, Vermillion chairman, president, and CEO. “Through Aspira Labs, we are focused on shifting healthcare 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 right care sooner.”

Integral to this effort is Aspira’s specialization in OVA1, a highly sensitive, FDA-cleared clinical decision support diagnostic tool used by obstetricians and 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.

OVA1 validation has been published in five clinical research articles involving 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.6–10 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 for consultation with a gynecologic oncologist, supporting best practices in ovarian cancer care.

In addition to OVA1, which is also available through Quest Diagnostics, Aspira Labs will offer physicians longitudinal CA 125II testing. The CA 125II baseline level is obtained from OVA1 testing prior to initial surgery and diagnosis of ovarian cancer. When the CA125II test is ordered by the gynecologic oncologist as part of post-surgical monitoring, Aspira provides a two-point graph comparing the baseline to a newly measured CA 125II result. This test report, in accordance with FDA cleared use of CA 125II, may help healthcare professionals detect residual disease or ovarian cancer recurrence.

Aspira will also support education regarding evidence-based health decisions–including website-based continuing education activities for healthcare professionals and educational resources for patients. In addition, Aspira will offer expert test result consultation for physicians, nurse practitioners, and physician assistants. Facilitating ease of access to the lab and its offerings is a large customer service field team, who together provide coverage throughout the United States.

Fritsche

Herbert A. Fritsche Jr, MD

Aspira Labs is led by medical director Herbert A. Fritsche Jr., PhD. Prior to his tenure at Aspira, Fritsche was a professor of biochemistry and clinical chemistry section chief in the department of pathology and laboratory medicine at the University of Texas MD Anderson Cancer Center in Houston. Fritsche has been recognized by the American Association for Clinical Chemistry with its presidential citation and the Morton K. Schwartz award for research and accomplishments in cancer diagnostics.

For further information, visit Aspira Labs.

References

1. American Cancer Society. Cancer Facts and Figures. Atlanta: ACS, 2013; www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf.

2. Ovarian Cancer National Alliance. Ovarian Cancer. www.ovariancancer.org/about-ovarian-cancer/statistics.

3. National Cancer Institute. Seer Stat Fact Sheets: Ovarian Cancer. http://seer.cancer.gov/statfacts/html/ovary.html.

4. Earle CC, Schrag D, Neville BA, et al. Effect of Surgeon Specialty on Process of Cancer Care and Outcomes for Ovarian Cancer Patients. J Natl Cancer Inst (2006); doi: 10.1093/jnci/djj019.

5. Bristow RE, Powell MA, Al-Hammadi N, et al. Disparities in Ovarian Cancer Care Quality and Survival according to Race and Socioeconomic Status. J Natl Cancer Inst (5June 2013); 105(11): 823–32; doi: 10.1093/jnci/djt065.

6. Ueland FR, DeSimone CP, Seamon LG, et al. Effectiveness of a Multivariate Index Assay in the Preoperative Assessment of Ovarian Tumors. Obstet Gynecol (2011); 117:1289–1297.

7. Ware MR, Smith A, DeSimone CP, et al. Performance of the American College of Obstetricians and Gynecologists’ Ovarian Tumor Referral Guidelines with a Multivariate Index Assay. Obstet Gynecol (2011); 117:1298–1306.

8. Bristow RE, Smith A, Zhang Z, et al. Ovarian Malignancy Risk Stratification of the Adnexal Mass Using a Multivariate Index Assay. Gynecol Oncol (2013); 128:252–259.

9. Bristow RE, Hodeib M, Smith A, et al. Impact of a Multivariate Index Assay on Referral Patterns for Surgical Management of an Adnexal Mass. Am J Obstet Gynecol (2013); 209:581.e1–581.e8.

10. Longoria TC, Ueland FR, Zhang Z, et al. 2014. Clinical Performance of a Multivariate Index Assay for Detecting Early-Stage Ovarian Cancer. Am J Obstet Gynecol (2014); 201:78.e1–78.e9.