AUSTIN, Texas, Nov. 9, 2015 — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, today announced that the National Institute for Health Care and Excellence (NICE) of the National Health Service (NHS) for the United Kingdom (UK), has ended its temporary hold on offering a Medtech Innovation Briefing (MIB) for Vermillion’s OVA1 product. The move was aligned with Vermillion’s European marketing strategy of introducing the recently announced CE marked Overa product instead of OVA1. NICE posted on its website, “NICE will not now produce a MIB on the OVA1 test because the company plans to launch a successor test to the NHS.” NICE MIBs are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies.
“We are pleased with NICE’s change of the status of the MIB for OVA1,” said Valerie Palmieri, President and CEO of Vermillion. “Based on receiving the CE mark from the European Union, we feel the NICE decision will clear the way for us to engage in a dialogue on how Vermillion’s Overa test can play a vital role in improving ovarian cancer care for women, not only in the UK, but for the entire European Union. Ovarian cancer is of significant concern due to the very low survival rates and we hope to help change those statistics with Overa in the UK.”
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, has diagnostic programs in gynecologic disease. The company’s lead diagnostics in the United States, OVA1, and in the European Union, Overa, are blood tests for pre-surgical assessment of ovarian tumors for malignancy, each using an innovative algorithmic approach. Overa and OVA1, which was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, represent a new class of software-based diagnostics.
- Overa is a simple blood test to help physicians assess the likelihood of ovarian cancer in connection with a suspicious pelvic mass. It is not a screening test; rather, Overa (CE Mark) is designed to be used with a general practioner’s or gynecologist’s overall clinical assessment to guide risk assessment and decision-making
- Overa measures the levels of five proteins found in the blood and then uses a proprietary software called OvaCalc® to calculate a single score. A woman’s risk of cancer is measured by using a 0-10 scale versus a single cut-off point of ³5
- A benign or low risk Overa test result may help the physician determine if a patient may be treated by a generalist and eliminate unnecessary referrals
- An elevated or high risk Overa test result may help the physician determine if the woman should have a gynecologic oncologist on their surgical team. Studies have shown that women with ovarian malignancies may experience better outcomes when they are operated on by a gynecologic oncologist.
- Overa is currently under review by the United States Food and Drug Administration and has received CE marking from the European Union
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