PR Newswire
AUSTIN, Texas, Sept. 9, 2016
AUSTIN, Texas, Sept. 9, 2016 /PRNewswire/ -- ASPiRA LABs, a Vermillion company (NASDAQ:VRML), today announced its support for the recent US Food and Drug Administration (FDA) safety communication which recommends against the use of any screening tests for ovarian cancer.
Earlier this week, the FDA announced that it is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency stated that it is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer.
As the medical community knows, ASPiRA LABs' FDA cleared technologies, OVA1® and Overa™, are NOT screening tests. OVA1/Overa are FDA cleared technologies to assess risk of ovarian cancer malignancy for women who present with a pelvic mass and are planned for surgery.
Vermillion is pleased that the FDA recognizes that there is no FDA cleared screening for ovarian cancer. The FDA communication also stated "Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer." There were other concerns, specifically to technology such as the ROCA Ca125 test, outlined in the FDA statement:
"Some women may receive test results that suggest ovarian cancer even though no cancer is present (a false-positive). These women may undergo additional medical tests and/or unnecessary surgery, and may experience complications related to both. Or, test results may not show ovarian cancer even though cancer is present (a false-negative), which may lead women to delay or not seek surgery or other treatments for ovarian cancer."
False-positive or false-negative test results can lead to incorrect treatment decisions by providers in their management of the risk of ovarian cancer.
"We believe this clarity around the use of non-FDA cleared tests for ovarian cancer screening, demonstrates the need to manage high risk pelvic mass patients at the onset with our FDA cleared technology," stated Valerie Palmieri, President and CEO of Vermillion/ASPiRA LABs. "No technology exists today to support screening, but we believe that our technology is the best available to assess risk, optimally manage patients, and lower overall healthcare costs. The mortality rate for ovarian cancer has not improved in 40 years and our goal is to change that statistic."
The power of OVA1 /Overa is the negative predictive value. The majority of pelvic masses are benign and Vermillion's data shows that 97% of the patients that have low risk OVA1/Overa results actually do have a benign mass. Thus, the results give doctors and their low risk patients "peace of mind" as they make their surgical decisions AND ensure that the elevated risk patients are referred to a gynecologic oncologist in the most efficient way. Unless an effective screening test becomes available, the OVA1 and Overa blood tests are the only FDA cleared diagnostic that can provide a cancer risk assessment for all stages, all ages and all types of ovarian cancer.
ASPiRA LABs welcomes comments on this position statement and other women's health issues. Please contact the company at [email protected].
About Vermillion
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®, 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 second generation OVA1 test with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.
About OVA1® and Overa™
Media Contact:
Katie Leighton
Leighton PR
610-513-6930
[email protected]
Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
[email protected]
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vermillion-and-aspira-labs-applaud-the-fdas-position-on-ovarian-cancer-screening-300325343.html
SOURCE Vermillion, Inc.
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