Vermillion publishes ovarian cancer symptoms index study
March 29, 2017 – AUSTIN. Vermillion announced the acceptance for publication of the original research titled, “Evaluation of a Validated Biomarker Test in Combination With a Symptom Index to Predict Ovarian Malignancy,” by Renata R. Urban, MD, et al, in the International Journal of Gynecological Cancer.
Ovarian cancer is expected to affect over 22,000 U.S. women in 2017 (1), greater than 200,000 women globally (2), and has the worst survival rate of all gynecological cancers, with a 5 year survival of less than 50% (1). Earlier detection and proper care pathways increase the chance of survival and patient outcomes (3-5), which has been the primary mission of Vermillion/ ASPiRA Labs since OVA1 (MIA) was first launched in 2010. In a seminal study published in 2009, (6) Dr. Barbara Goff and colleagues defined a set of symptoms that were useful in identifying women with ovarian cancer, and developed a symptom index (SI) relating these symptoms to the likelihood and severity of the disease and suggested that symptoms may facilitate earlier detection. In a 2016 study performed with 218 patients who presented with pelvic masses, the combination of SI and OVA1 (MIA) showed a sensitivity to detect primary ovarian malignancy of 100%, detecting both early and late stage cancers better than either SI or OVA1 (MIA) alone. Additionally, the negative predictive value of SI and OVA1 combined was also 100%, indicating that all women that tested negative for both tests were certain not to have a primary ovarian malignancy (7).
The appropriate referral of patients who are high risk for ovarian cancer is necessary for optimal outcomes; however, referral of benign cases can increase wait times for a specialist visit and often, if unnecessary, can increase anxiety and other burdens for the patient. Using all preoperative information available to the clinician, which includes symptoms, physical exam, ultrasound findings, and OVA1 (MIA) results can facilitate the appropriate triage of patients with a pelvic mass either to the Gynecologic Oncologist or to remain with their OB/Gyn provider for care and surgery.
“Vermillion is dedicated to working towards improving the lives and outcomes of women with ovarian cancer, and we are very encouraged by the results of this latest study,” stated Marra Francis, MD, FACOG, CMO of Vermillion.
OVA1 (MIA) is now considered a Level B Recommendation by ACOG (8). Based on its support by ACOG, NCCN update and SGO positive position statement, OVA1 (MIA) can be the physician’s first choice in biomarker panels to best triage their pelvic masses to the most appropriate care pathway. There is no other comparable technology on the market today.
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases. The company’s initial in vitro diagnostic test, OVA1® (MIA), was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016 Vermillion received FDA clearance for Overa™, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use.
SOURCE Vermillion, Inc.