News Article

Vermillion Completes Validation of New Pre-Surgical Test Offerings with OVA1®plus, including COVID-19 Antibody Testing and Additional Pelvic Mass Risk Assessment Biomarkers

Press Release

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AUSTIN, Texas — June 10, 2020 — Vermillion, Inc. (Nasdaq: VRML), a bioanalytical-based women’s health company focused on gynecologic disease, is excited to announce that its wholly-owned subsidiary ASPIRA Labs has completed laboratory validation of the Roche Elecsys Anti-SARS-CoV-2 antibody test for detecting the presence of COVID-19 antibodies. Our Laboratory has also completed the validation of several additional oncology biomarkers.  Both the COVID-19 antibody test and additional biomarkers will be used in an ASPIRA pelvic mass risk assessment pre-surgery workup. 

ASPIRA Labs selected to validate the Roche Elecsys Anti-SARS-CoV-2 antibody test because it detects both IgG and IgM antibodies.  Testing for IgG and IgM antibodies yields a specificity of 99.81% and a sensitivity of 100% (100% sensitivity when greater than or equal to14 days post PCR confirmation)1.  The completed validation of COVID-19 antibody and additional pelvic mass risk assessment biomarkers will be offered commercially by the end of June in conjunction with our proprietary OVA1®plus test.  The additional oncology biomarkers are CEA, CA19.9, LDH, Beta HCG, and AFP.  These laboratory tests are essential in helping physicians identify less frequent ovarian tumor types as part of the pre-surgical workup.

“These additional offerings further establish ASPIRA Labs as a leader in pelvic mass assessment by providing physicians the ability to order tests for additional biomarkers.  These offerings also help ensure physicians get access to all the testing they need to assess pelvic mass ovarian cancer risk especially in the current healthcare environment with COVID-19” said Valerie Palmieri, President and Chief Executive Officer of Vermillion, Inc.

1 Roche Diagnostics Product Release Bulletin “Elecsys® Anti-SARS-CoV-2 Immunoassay”

About Vermillion Inc.

Vermillion, Inc. is transforming women’s health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management and improve gynecologic health outcomes for women. OVA1®plus combines our FDA-cleared products OVA1® and OVERA® to detect the risk of ovarian malignancy in women with adnexal masses. Recently launched, ASPiRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus.  With over 10 years of expertise in ovarian cancer risk assessment, Vermillion has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection, and optimize treatment plans. Visit our website for more information about our products at www.vermillion.com.

Contact:

  • Investor Relations Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    Tel 617-430-7577

Forward-Looking Statements

This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995 including statements regarding the anticipated addition of Vermillion common stock to the Russell 3000 Index and effects thereof. These statements involve a number of risks and uncertainties.  All statements other than statements of historical facts contained in this press release are forward-looking statements. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties inherent in Vermillion’s business, including those described in the section entitled “Risk Factors” in Vermillion’s Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by the section entitled “Risk Factors” in Vermillion’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020. The events and circumstances reflected in Vermillion’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.  Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.