AUSTIN, Texas, Jan. 4, 2017 /PRNewswire/ -- Vermillion (NASDAQ: VRML) and ASPiRA LABS, a Vermillion company, today announced the receipt of an FDA Clarification Letter regarding OVA1 (MIA) and Overa (MIA2G). This letter (see attached) is in reference to the September 7, 2016 FDA Safety Communication advising women and their physicians against the use of ovarian cancer screening tests for asymptomatic women.
In order to avoid any confusion as well as to document the FDA position on OVA1 (MIA) and Overa (MIA2G), Jeffrey Shuren, M.D, J.D, Director: Center for Devices and Radiological Health at the FDA, sent a letter to Vermillion, dated December 21, 2016. In the letter, Dr. Shuren stated: "We agree that this safety communication does not apply to Vermillion's FDA-cleared tests, OVA1 (MIA) and Overa (MIA2G), which are not screening tests for ovarian cancer."
"FDA cleared OVA1 (MIA) and Overa (MIA2G) as aids to further assess the likelihood that malignancy is present when the physician's independent clinical and radiological evaluation does not indicate malignancy. The intended uses of the two assays are the same-to help physicians more reliably identify which patients would benefit from consultation with or referral to a gynecologic oncologist. OVA1 (MIA) and Overa (MIA2G) are indicated for women who present with an adnexal mass."
Valerie Palmieri, President and CEO of Vermillion stated, "Based on the FDA Clarification, along with our 'new' Level B status in the latest ACOG Guidelines on the Adnexal Mass4 as well as NCCN support, we believe we have the strongest clinical solution for women and their physicians to assess a patient's risk of ovarian cancer when they present with a pelvic mass."
Vermillion is dedicated to the fight to improve outcomes for women diagnosed with ovarian cancer by identifying the disease at earlier stages and facilitating their transfer of care to a specialist sooner, which is well known to improve patient outcomes and survival1-3. The Company markets the only FDA cleared technology available today to identify risk of ovarian malignancy for all ages, all stages and all ovarian cancer types.
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® (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 Overatm, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.
About OVA1® and Overatm
1. Chan JK, Kapp DS, Shin JY, et al. Influence of the gynecologic oncologist on the survival of ovarian cancer patients. Obstet Gynecol. 2007;109:1342Y1350.
2. Engelen MJ ,Kos HE,Willemse PH,etal. Surgery by consultant gynecologic oncologists improves survival in patients with ovarian carcinoma. Cancer. 2006;106:589Y598.
3. Vernooij F,Heintz P,Witteveen E,etal.The outcomes of ovarian cancer treatment are better when provided by gynecologic oncologists and in specialized hospitals: a systematic review. Gynecol Oncol. 2007;105:801Y812
4. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin. Management of adnexal masses. Obstet Gynecol. 2016; 128: e210-26.
Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
[email protected]
SOURCE Vermillion, Inc.
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