Vermillion, Inc. Announces the Launch of OVA1®+

Vermillion, Inc. Announces the Launch of OVA1®+

The new best-in-class reflex offering combines strengths from OVA1Òand OVERAÒ

Access the full press release, here.

AUSTIN, Texas — October 9, 2018 — Vermillion, Inc. (NASDAQ: VRML), a bioanalytical-based women’s health company focused on gynecologic disease, today announced the launch of its enhanced reflex offering OVA1®+, through its wholly owned subsidiary, ASPiRA Labs, Inc. The new best-in-class offering combines the strengths from both of its FDA-cleared proprietary technologies: OVA1® and OVERA® (MIA, MIA2G, Multivariate Index Assay 1stand 2ndgeneration), which evaluate ovarian cancer risk in women with a pelvic mass prior to surgical treatment. OVA1®+ is a reflex process which performs OVA1® and, if indicated due to elevated OVA1® results, also performs OVERA®.

“We are continuing to innovate on behalf of healthcare providers, patients and their families. Creating the OVA1®+ reflex process enhances the information already provided by OVA1® alone, and allows us to put even more information in the hands of clinicians,” said Valerie Palmieri, CEO of Vermillion.  “The feedback from the initial pilot has been very positive, and we are excited to now be able to offer OVA1®+.”

The OVA1®+ reflex process was created based on provider feedback. OVA1®+ allows customers to access the benefits of OVA1®, while providing the benefits of OVERA® when needed. When a reflex is indicated, the results for both OVA1® and OVERA® are reported on one clinical informatic report. Combining these two proprietary tests as a reflex process leverages the strengths of each and provides enhanced information to healthcare providers.

Benefits of the OVA1®+ reflex process include:

  • Maintaining the high early stage detection rate for risk of malignancy
  • Improved intermediary risk test performance by 40%
  • Continuing to provide up to a 98% negative predictive value, a low risk OVA1® result indicates a low malignancy risk

Currently, OVA1® is the only FDA cleared, American College of Obstetrics and Gynecologist (ACOG) endorsed, Medicare-covered, ovarian cancer risk assessment for all ages, all stages, all ethnicities and all cancer types. Plus, 40% of the lives in the US are under positive medical coverage for OVA1®.

About Vermillion, Inc.

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. Vermillion’s tests are intended to characterize and stage disease, and to help guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, to perform additional testing, or to assist in monitoring response to therapy.

Visit our website for more information about our products at www.vermillion.com

Investor Relations Contact:

Ashley R. Robinson

LifeSci Advisors, LLC

Tel: 617-535-7742

arr@lifesciadvisors.com