2014

American Journal of Obstetrics & Gynecology Publishes New Clinical Study on the Relationship Between Imaging and OVA1® in Assessing Risk of Ovarian Cancer New Analysis Explores Interactions Between Clinical Risk Factors Used in Pre-surgical Assessment

 

 

 

 

 

AUSTIN, Texas, March 20, 2014 /PRNewswire/ -- (Nasdaq:  VRML) -- A new study of OVA1® clinical performance, titled "The Effect of Ovarian Imaging on the Clinical Interpretation of a Multivariate Index Assay," has been released as an online advance publication of The American Journal of Obstetrics & Gynecology.[1] The study examines the relationship between two commonly used imaging methods – ultrasound (US) and computed tomography (CT) – and the OVA1 test result, in assessing the risk of ovarian cancer among patients planning surgery for an ovarian mass. OVA1 is an FDA-cleared blood test that measures the levels of five proteins and then uses a proprietary algorithm and software called OvaCalc® to calculate a single risk score.

"This new study advances our understanding of how OVA1 and imaging work together in the pre-surgical assessment of ovarian cancer risk," said study co-author Fred Ueland, M.D., associate professor of gynecologic oncology at the University of Kentucky's Markey Cancer Center. "This is important for two reasons. First, adding OVA1 reduced the number of ovarian cancers missed with imaging alone, by 85 to 90 percent. Recent publications have reinforced that the first surgery is an important opportunity to improve ovarian cancer survival by ensuring that cancers are detected earlier and that they are operated on by the most experienced specialists. Second, this study provides new evidence of how menopausal status, imaging and OVA1 score may interrelate."

Dr. Scott Goodrich of the University of Kentucky led the study in collaboration with colleagues Drs. Fred Ueland and Rachel Ware Miller. The findings are the third in a series of subset analyses of data obtained from 1,100 ovarian mass surgery patients in two previous pivotal trials of OVA1 clinical performance, conducted in 2007 and 2012. The authors compared the performance of each imaging method alone, to the performance of OVA1 alone (for risk stratification), as well as in combination with OVA1. In addition, the authors presented logistic regression models showing how menopausal status, high- or low-risk imaging and OVA1 score interact in the assessment of ovarian cancer risk. The researchers concluded that "serum biomarkers and imaging are a complementary set of clinical tools and that when the [OVA1] score is further stratified by imaging risk and menopausal status, there is a better understanding of the clinical risk of ovarian malignancy."

This latest study brings the number of full research articles on OVA1 clinical performance to a total of five peer-reviewed publications. Together, these data provide strong, prospective clinical evidence that OVA1 improves the pre-surgical detection of ovarian cancer, regardless of stage or subtype, in patients undergoing surgery for a suspicious ovarian mass.

"The sensitivity of OVA1 is critical to the detection of ovarian malignancy, pre-surgical risk assessment and determining whether a woman may benefit from consultation with a gynecologic oncologist prior to surgery," said Donald Munroe, chief scientific officer and SVP of business development at Vermillion. "Vermillion is committed to fully developing this clinical evidence, together with future studies on how OVA1 may impact the efficiency and quality of care for women facing ovarian cancer, the deadliest of all gynecologic malignancies."

More than 22,000 women are diagnosed with ovarian cancer in the United States annually, and more than 14,000 die each year.[2] Leading medical associations, including the American College of Obstetrics and Gynecology (ACOG), recommend that women with suspected ovarian cancer be referred to a gynecologic oncologist for surgery for the best potential outcomes. However, only an estimated one-third of women who have a malignant tumor are operated on by a gynecologic oncologist for the initial removal of cancer.[3]

This publication, "The Effect of Ovarian Imaging on the Clinical Interpretation of a Multivariate Index Assay," is also co-authored by Dr. Robert Bristow (UC Irvine, Calif.), Dr. Joseph Santoso (The West Clinic, Tenn.), Dr. Zhen Zhang (Johns Hopkins Medical Institute) and Alan Smith (Applied Clinical Intelligence). It will be published in print in the 2nd quarter of 2014 in the American Journal of Obstetrics & Gynecology.

METHODS AND FINDINGS

The study evaluated a combined population from the OVA1 FDA registration and OVA500 confirmatory trials, for a total of 1,024 evaluable patients 18 years or older, and planning surgery for ovarian masses. To assess the value of OVA1 added to routine assessment, enrolling physicians were allowed to use their preferred method of imaging. Since OVA1 is not indicated for women with clinical evidence of advanced ovarian cancer, ascites and metastatic implants, the small number of patients with these indicators was excluded from the analysis, leaving a total of 721 evaluable subjects who were imaged with ultrasound (US), and 313 with CT scanning. Patients imaged with MRI were also excluded from the analysis due to low numbers (N=43) confounding statistical interpretation. Overall clinical performance of US, CT and OVA1 is presented in the Data Summary table below, along with the performance when OVA1 is combined with imaging as a logical "OR" function (along with the performance of OVA1 in combination with imaging as a logical "OR" function), per the product's risk stratification protocol. In addition, this combination of ultrasound and OVA1 detected 95 percent of early-stage ovarian cancers, consistent with previous reports of the combined study population.

Data Summary:

Results

All Imaging (N=1,024)

Ultrasound (N=721)

CT Imaging (N=313)

Alone

+OVA1*

US Alone

+OVA1*

CT Alone

+OVA1*

Sensitivity

78.5%

(153/195)

97.4%

(190/195)

76.9%

(70/91)

97.8%

(89/91)

79.8%

(83/104)

97.1%

(101/104)

Specificity

53.8%

(451/839)

28.5%

(239/839)

55.4%

(349/630)

30.8%

(194/630)

48.8%

(102/209)

21.5%

(45/209)

Positive Predictive Value

28.3%

(153/541)

24.1%

(190/790)

19.9%

(70/351)

17.0%

(89/525)

43.7%

(83/190)

38.1%

(101/265)

Negative Predictive Value

91.5%

(451/493)

98.0%

(239/244)

94.3%

(349/370)

99.0

(194/196)

82.9%

(102/123)

93.8%

(45/48)

Cancers Missed

21.5%

(42/195)

2.6%

(5/195)

23.3%

(21/90)

2.2%

(2/91)

20.2%

(21/104)

2.9%

(3/104)

*Patient was classified as a high-risk result if imaging OR OVA1 risk score were high risk, per OVA1 risk protocol.

About the American Journal of Obstetrics & Gynecology
The American Journal of Obstetrics & Gynecology (www.AJOG.org), known as "The Gray Journal," presents comprehensive coverage of the obstetrics and gynecology specialty, including maternal-fetal medicine, reproductive endocrinology/infertility and gynecologic oncology.

 

About Vermillion
Vermillion, Inc. (NASDAQ: VRML) is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic oncology and women's health.

The company's lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.

Forward-Looking Statements
Certain matters discussed in this press release contain forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion's plans, objectives, expectations and intentions. These forward-looking statements are based on Vermillion's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty as to Vermillion's ability to protect and promote its proprietary technology; (2) Vermillion's lack of a lengthy track record successfully developing and commercializing diagnostic products; (3) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its future diagnostic products; (4) uncertainty of the size of market for its existing diagnostic tests or future diagnostic products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third-party payers such as private insurance companies and government insurance plans; (5) uncertainty that Vermillion has sufficient cash resources to fully commercialize its tests and continue as a going concern; (6) uncertainty whether the trading in Vermillion's stock will become significantly less liquid; and (7) other factors that might be described from time to time in Vermillion's filings with the Securities and Exchange Commission. All information in this press release is as of the date of this report, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion's expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.

This release should be read in conjunction with the consolidated financial statements and notes thereto included in our most recent reports on Form 10-K and Form 10-Q. Copies are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov.

Media Relations Contacts:
Feinstein Kean Healthcare

Lynn Blenkhorn
lynn.blenkhorn@fkhealth.com
Tel 508-851-0930

Monique LaRocque
monique.larocque@fkhealth.com
Tel 202-903-4268

 

Investor Relations Contact:
Liolios Group, Inc.
Ron Both
vrml@liolios.com
Tel 949-574-3860

 

 

References:

[1] Goodrich ST, Bristow RE, Santoso JT, et al. The effect of ovarian imaging on the clinical interpretation of a multivariate index assay. Am J Obstet Gynecol (2014) doi: 10.1016/j.ajog.2014.02.010. [Epub ahead of print]

[2] National Cancer Institute. Seer Stat Fact Sheets – Ovarian Cancer. http://seer.cancer.gov/statfacts/html/ovary.html.

[3] Earle CC, Schrag D, Neville BA, et al. Effect of Surgeon Specialty on Process of Cancer Care and Outcomes for Ovarian Cancer Patients. J Natl Cancer Inst (2006) doi: 10.1093/jnci/djj019.

SOURCE Vermillion, Inc.



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