COVID-19: Information on ASPIRA LABS Operations

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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


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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”