Tag Archives: Quest Diagnostics

OVA1 Blood Test Detects Ovarian Cancer In Women With A Known Ovarian Mass More Accurately Than CA-125

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A study published online in Obstetrics & Gynecology reports that the OVA1 blood test detects ovarian cancer in women with a previously discovered ovarian mass more accurately than the CA-125 blood test. The study also considers OVA1’s place in future surgical referral guidelines.

A study published online ahead of print in the June 2011 edition of Obstetrics & Gynecology demonstrated that American College of Obstetrics and Gynecology (ACOG) guidelines for determining the likelihood that an ovarian mass is cancerous prior to surgery would accurately identify more women with ovarian cancer if the OVA1 blood test were used in place of the currently recommended CA-125 (cancer antigen 125) blood test. The study builds on prior research that shows accurate assessment of an ovarian mass for cancer prior to surgery can affect both treatment decisions and health outcomes for women with ovarian cancer.

… When OVA1 was used in place of CA 125 as recommend in the [ACOG] guidelines, 94% of malignancies in women of all ages in the study were accurately detected compared to 77% with CA-125. In addition, OVA1 improved sensitivity in premenopausal women, accurately detecting 91% of women with ovarian cancer in fewer than 58% with CA125. … The study also showed that the OVA1 test was about two times more likely to incorrectly identify women as high risk for ovarian cancer when they were not (a “false positive“) as compared to the CA-125 test overall. … 

OVA1 is the first test cleared by the U.S. Food and Drug Administration (FDA) for aiding in the pre-surgical evaluation of a woman’s ovarian mass for cancer. Vermillion, Inc., a molecular diagnostics company, developed OVA1, and Quest Diagnostics Incorporated, the world’s leading diagnostic testing company, offers OVA1 testing services in the United States and India. Quest Diagnostics and Vermillion both participated in the study and Vermillion also helped fund the study. Neither company had any involvement in the development of the manuscript.

Clinical practice guidelines recommend that women with ovarian cancer be under the care of a gynecologic oncologist, although only an estimated one-third of initial surgeries for ovarian cancer are performed by these specialists. ACOG guidelines for the management of ovarian masses recommend that physicians evaluate several factors, including menopausal status, imaging findings, family history, and CA 125 blood test levels, to divide women into low- and high-risk categories on which treatment plans, including surgical referral, are based.

The study evaluated the performance of the ACOG guidelines using the CA-125 test versus the OVA1 test in 516 women scheduled for surgery for an ovarian mass across a diverse group of primary and specialty care centers. When OVA1 was used in place of CA-125 as recommend in the guidelines, 94% of malignancies in women of all ages in the study were accurately detected compared to 77% with CA 125. In addition, OVA1 improved sensitivity in premenopausal women, accurately detecting 91% of women with ovarian cancer in fewer than 58% with CA-125.

Rachel Ware Miller, M.D., Assistant Professor, Gynecologic Oncology, Markey Cancer Center, University of Kentucky

“The high sensitivity in premenopausal women and early stage cancers is where CA-125 and the College guidelines have underperformed,” wrote investigator Rachel Ware Miller, M.D., assistant professor gynecologic oncology at the University of Kentucky’s Markey Cancer Center, in the study. ” Identifying these patients for referral is valuable because many are not receiving appropriate surgical staging and treatment. An effective preoperative test, particularly for younger women and early-stage cancers, can have a favorable effect on women’s health as survival is better in these populations.”

OVA1 when used with the College guidelines was also effective at detecting advanced disease, when surgery and chemotherapy can “improve overall survival,” wrote Dr. Miller.

The study also showed that the OVA1 test was about two times more likely to incorrectly identify women as high risk for ovarian cancer when they were not (a “false positive“), as compared to the CA-125 test overall. However, as OVA1 is only indicated for women for whom surgery is already planned, a higher rate of false positives would increase the possibility that a woman’s surgery is performed by a gynecologic oncologist rather than a gynecologist or other non-specialist.

The study follows the March 2011 publication in Obstetrics & Gynecology, the official publication of ACOG, of an updated committee opinion, The Role Of The Obstetrician-Gynecologist In The Early Detection Of Epithelial Ovarian Cancer, by ACOG and Society of Gynecologic Oncologists (SGO) that cited the FDA clearance of OVA1 (in 2009) and indicated that OVA1 “appears to improve the predictability of ovarian cancer in women with pelvic masses” and “may be useful for evaluating women with a pelvic mass.”

“Prior to OVA1’s clearance by the FDA, the only lab test physicians could use to assess the likelihood that an ovarian mass was malignant prior to surgery was CA-125, even though CA-125 is not indicated for this use and its performance is variable,” said Dr. Eric T. Fung, chief science officer, Vermillion, Inc. “These data should give physicians more confidence to refer women whose OVA1 test result indicates a high likelihood of cancer to a gynecologic oncologist for surgery.”

Ovarian cancer is the leading cause of death from gynecologic cancers in the United States and the fifth-leading cause of cancer deaths in women. Ovarian masses affect an estimated one million women and lead to as many 300,000 ovarian mass surgeries in the United States each year, according to an analysis by third parties on behalf of Quest Diagnostics.

About OVA1®

OVA1 is the first test cleared by FDA for aiding in the pre-surgical evaluation of a woman’s ovarian mass for cancer, and also is the first protein-based In Vitro Diagnostic Multi-Variate Index Assays (IVDMIA), a new class of state of the art software-based diagnostics. The test utilizes five well-established biomarkers — transthyretin (TT or prealbumin), apoolipoprotein A-1 (Apo A-1), beta 2-microglobulin (beta 2M), transferrin (Tfr) and cancer antigen 125 (CA-125 II) — and proprietary software to determine the likelihood of malignancy in women with ovarian mass for whom surgery is planned.

OVA1 is indicated for women who meet the following criteria: (i) over age 18, (ii) ovarian adnexal mass present for which surgery is planned, and (iii) not yet referred to an oncologist. It is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

About Quest Diagnostics

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at http://www.questdiagnostics.com/.

About Vermillion, Inc.

Vermillion, Inc. is dedicated to the 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 oncology, cardiology and women’s health. Additional information about Vermillion can be found on the Web at http://www.vermillion.com/.

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FDA Clears Vermillion’s “OVA1” Test To Determine Likelihood of Ovarian Cancer In Women With Pelvic Mass

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The U.S. Food and Drug Administration cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

First Lab Test That Can Indicate Ovarian Cancer Prior To Biopsy Or Exploratory Surgery

U.S. Food & Drug Administration

The U.S. Food and Drug Administration (FDA) cleared the OVA1™ Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy.

The U.S. Food and Drug Administration (FDA) cleared the OVA1™ Test [formerly, the Ovarian Tumor Triage Test], the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy. The test was developed by Vermillion, Inc. (formerly, Ciphergen Biosystems, Inc. ), a molecular diagnostics company, in cooperation with Quest Diagnostics, the world’s leading provider of cancer diagnostics. Quest Diagnostics, which is a long-time investor in research and development of the OVA1 technology, has exclusive rights to offer the test to the clinical reference laboratory market in the U.S. for three years.

“When combined with other clinical information, the OVA1 biomarker panel can help assess the likelihood of malignancy of an ovarian tumor before surgery and facilitate decisions about referral to a gynecologic oncologist,” said Frederick R. Ueland, M.D., principal investigator of the prospective, multi-center OVA1 clinical trial. Dr. Ueland is an associate professor gynecologic oncology at the University of Kentucky‘s Markey Cancer Center.

The OVA1 Test is an in vitro diagnostic multivariate index [assay] (IVDMIA) test that combines the results of five immunoassays using a proprietary unique algorithm to produce a single numerical score indicating a women’s likelihood of malignancy. The OVA1 Test provides a new option in the pre-operative evaluation to help physicians assess if a pelvic mass is benign or malignant in order to help determine whether to refer a woman to a gynecologic oncologist for surgery. Numerous clinical practice guidelines recommend that women with ovarian cancer be under the care of a gynecologic oncologist. However, only an estimated one third of women who undergo surgery for possible ovarian cancer are referred to these specialist surgeons for their surgery.(1)

Vermillion received the Society for Gynecologic Oncologists (SGO) Basic Science Poster Award for an abstract on the performance of its OVA1 Test presented at SGO’s 38th Annual Meeting on Women’s Cancer in 2007. In reviewing the test application, the FDA evaluated results of a prospective, double-blind clinical trial which included 27 demographically mixed sites representative of institutions where ovarian tumor subjects may undergo a gynecological examination.

“Surgery in the hands of a gynecologic oncologist is usually associated with more favorable patient outcomes,” said Jon R. Cohen, M.D., chief medical officer and senior vice president, Quest Diagnostics. “Physicians often do not know if a woman’s pelvic mass is malignant or benign until she undergoes surgery. The OVA1 Test is the first FDA-cleared blood test to help clinicians determine whether to refer a woman to a gynecologic oncologist or have a gynecologic oncologist present at the time of surgery. We believe this test will help drive more favorable patient outcomes.”

“Unfortunately, advances in ovarian cancer diagnosis and treatment are few and far between. It is fitting that September, Ovarian Cancer Awareness Month, marks FDA’s clearance of OVA1, a test that represents an important step forward toward improved outcomes,” said Gail S. Page, executive chairperson of the board of directors of Vermillion. “Quest Diagnostics had the foresight to recognize the potential value of this novel multivariate assay and supported its development. We look forward to collaborating to bring this new diagnostic option to the many women who will benefit from specialist care.”

Ueland

"When combined with other clinical information, the OVA1 biomarker panel can help assess the likelihood of malignancy of an ovarian tumor before surgery and facilitate decisions about referral to a gynecologic oncologist," said Frederick R. Ueland, M.D., principal investigator of the prospective, multi-center OVA1 clinical trial. Dr. Ueland is an associate professor gynecologic oncology at the University of Kentucky's Markey Cancer Center.

The FDA clearance of OVA1 makes Quest Diagnostics the only diagnostic testing company to offer FDA cleared tests for ovarian cancer in the pre- and post-surgical settings. In addition to offering the OVA1 Test, Quest Diagnostics was the first laboratory company to provide a new lab test that the FDA cleared in the third quarter of 2008 as an aid for monitoring for recurrence of epithelial ovarian cancer.

The OVA1 Test will be available for physician use in the fourth quarter of this year.

Ovarian cancer is the leading cause of death from gynecologic cancers in the United States and the fifth-leading cause of cancer deaths in women.(2) Approximately 21,600 new cases of ovarian cancer will be diagnosed in the U.S. in 2009, and approximately 14,600 women will die of the disease.(3)

About the OVA1 Test

The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The test utilizes five well-established biomarkers — Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) — and a proprietary algorithm to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned.

The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

About Vermillion

Vermillion, Inc. 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 oncology, hematology, cardiology and women’s health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at www.vermillion.com.

About Quest Diagnostics

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at www.QuestDiagnostics.com.

(1) Journal of the National Cancer Institute, Vol. 98, No. 3, February 1, 2006

(2) Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000;50(1):7-33

(3) 2009 American Cancer Society [Leading Sites of New Cancer Cases and Deaths—2009 Estimates]

Contacts:
Quest Diagnostics:
Media: Wendy Bost 973-520-2800
Investors: Kathleen Valentine 973-520-2900

Vermillion:
Jill Totenberg, he Totenberg Group Tel: 212 994 7363
jtotenberg@totenberggroup.com

Select FDA Comments:

The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

Sources:

Vermillion Files FDA Pre-Market Application for OVA1 Ovarian Tumor Triage Test

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” …The OVA1 [Ovarian Tumor Triage Test] test will help assess the risk of malignancy in the hundreds of thousands of women who require surgery for ovarian tumors each year. ‘This information can be used to identify those who might benefit from referral to a gynecologic oncologist,’ said Fred Ueland, M.D., principal investigator of the study and Associate Professor of Gynecologic Oncology at the University of Kentucky. While most tumors are benign, numerous studies have shown that women with ovarian cancer have better overall outcomes when their surgery is performed by a gynecologic oncologist.”

“ FREMONT, Calif., June 25 /PRNewswire-FirstCall/ — Vermillion, Inc. (Nasdaq: VRML), a molecular diagnostics company, today announced that it has submitted a 510(k) pre-market notification application to the U.S. Food & Drug Administration (FDA) requesting regulatory clearance of its Ovarian Tumor Triage Test known as OVA1™.

As announced previously, the OVA1 prospective clinical trial met its primary endpoints, indicating that the test is capable of stratifying women with pelvic masses into high- and low-risk categories to help determine whether the patient should be referred to a specialist prior to surgery. The clinical trial was one of the largest ovarian cancer studies ever conducted and assessed more than 550 women with a confirmed adnexal mass at 27 clinical sites in the United States. Additionally, the trial was the culmination of more than eight independent studies in more than 2,500 women.

The OVA1 test will help assess the risk of malignancy in the hundreds of thousands of women who require surgery for ovarian tumors each year. ‘This information can be used to identify those who might benefit from referral to a gynecologic oncologist,’ said Fred Ueland, M.D., principal investigator of the study and Associate Professor of Gynecologic Oncology at the University of Kentucky. While most tumors are benign, numerous studies have shown that women with ovarian cancer have better overall outcomes when their surgery is performed by a gynecologic oncologist.

This is an important milestone for Vermillion and a significant step toward the commercialization of OVA1™. ‘We are pleased with the results of the trial and look forward to discussing the significance of our data and our commercialization strategy in an upcoming investor roundtable, planned for July,’ said Gail Page, President and CEO of Vermillion. ‘We also look forward to receiving regulatory clearance from the FDA and making OVA1 available to the hundreds of thousands of women who could benefit considerably from the test.’

Vermillion will host a roundtable teleconference to address the need for OVA1 on Tuesday, July 15. Fred Ueland, M.D., principal investigator of the OVA1 clinical study, will serve as the keynote speaker. Conference call details, including dial-in information and timing, are forthcoming.

About Vermillion’s Ovarian Cancer Diagnostic Program

In addition to developing a diagnostic test designed to distinguish between benign and malignant pelvic masses, Vermillion has a broad program of ovarian cancer diagnostic tests in development. Studies are underway to validate diagnostic tests developed to detect early-stage ovarian cancer, predict prognosis and recurrence, and identify women considered at high-risk for the disease.

Vermillion’s comprehensive diagnostic development program is being conducted with several leading collaborators at The Johns Hopkins School of Medicine, The University of Texas M.D. Anderson Cancer Center, Rigshospitalet (Copenhagen), and the University of Kentucky.

The Company’s OVA1 test is part of a strategic alliance with Quest Diagnostics to jointly develop and commercialize diagnostic tests.

About Vermillion

Vermillion, Inc. 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 oncology, hematology, cardiology and women’s health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at http://www.vermillion.com.”

[Quoted Source: Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test – Significant Milestone Achieved Based on Compelling Clinical Studies, Vermillion, Inc. Press Release, June 25, 2008.]

Additional Information:  To learn more about molecular diagnostics and proteomics, see Understanding Cancer Series: Molecular Diagnostics, National Cancer Institute, September 1, 2006.