About OVA1

OVA1, Vermillion’s first-generation Multivariate Index Assay (MIA), minimizes the uncertainty of the pre-surgical adnexal mass work-up. Using five biomarkers and the patient’s menopausal status, the FDA-cleared OVA1 test helps detect more ovarian cancer than standard testing. This can initiate optimal surgery with a cancer specialist earlier in the care pathway. And with 96% of cancers stratified, you can confidently manage adnexal masses determined as low risk.

Watch Video

OVA1: Value of a Panel

Practice Bulletin 174

American Congress of Obstetricians and Gynecologists

Read the ACOG Practice Bulletin on “Evaluation and Management of Adnexal Masses”

Position Statement

Society of Gynecologic Oncology

See the SGO Position Statement on “Multiplex Serum Testing for Women with Pelvic Mass”

OVA1 Case Studies

Case Presentation

A 72-year-old patient presented with an asymptomatic left adnexal mass reflected on routine examination.

Clinical Impression

The patient was found on routine examination to have an 8cm left adnexal mass which was a new finding from an examination performed one year previously.

The sonogram showed that the mass did have cystic components and septae. There was no fluid in the cul-de-sac and otherwise the findings were benign. The patient wanted to be operated on locally, because of an infirmed husband. The treating physician consulted with Dr. Barter, who suggested an OVA1 be ordered to help give a probability of malignancy. The test was ordered and the result came back at 4.0 which is below the postmenopausal cutoff of 4.4, indicating a lower probability of malignancy.

Diagnosis

The patient underwent a local laparoscopic bilateral salpingo-oophorectomy (BSO) performed by her treating physician without problems and pathology revealed a benign mucinous cystadenoma.

Use of OVA1

In this case, the use of OVA1 was very important because the score indicated a benign lesion. This allowed the patient to be operated on locally by a non-gynecologic oncologist. Had the score been elevated, the patient had agreed to travel to a gynecologic oncologist. In a postmenopausal patient with this type of mass, there is a high likelihood of malignancy. The use of OVA1 revealed benign findings and the patient did not need to be referred.

James F. Barter, M.D. – Rockville, MD – Specialty: Gynecologic Oncology

Case Presentation

At the time of her annual exam, a 75-year-old female complained of vague pelvic pressure for two to three months but her bimanual exam was normal. She also had been experiencing fatigue and unexplained but undocumented weight loss. Her only medical problems included mild hypertension and a history of a lung nodule that was stable on serial CT scans of the chest. Additionally, she had a single port access vaginal hysterectomy for menorrhagia 30 years previously.

Clinical Impression

A pelvic ultrasound performed by the gynecologist revealed a 6.5cm cystic right ovarian mass with a few thin septations. A CA-125 was drawn and was mildly elevated at 83. The gynecologist consulted with Dr. Braly to address whether he could perform a laparoscopic BSO or whether she should be referred for gynecologic oncology evaluation and surgery. Dr. Braly recommended that an OVA1 test be ordered to help with that decision.

The OVA1 test was ordered and returned a score of 10.0, indicating a high likelihood of malignancy.

The patient was then referred to Dr. Braly for evaluation; however, her exam was also unremarkable. On the basis of the elevated OVA1, a CT scan was ordered and it showed multiple pulmonary nodules, mediastinal adenopathy, a small omental mass worrisome for metastatic disease and a complex solid and cysticright pelvic mass.

Diagnosis

Therapeutic options were discussed with the patient, including attempted biopsy to confirm malignancy with neoadjuvant chemotherapy, or surgery to confirm her diagnosis and tumor debulking followed by chemotherapy. She underwent a Robotic BSO, omentectomy and tumor debulking with her final diagnosis being a Stage IV, optimally debulked papillary serous ovarian cancer.

Use of OVA1

It is Dr. Braly’s belief that this case confirms the value of OVA1. The original plan was for the gynecologist to perform a laparoscopic BSO because of the benign appearing ovarian cyst and the minimally elevated CA-125. Instead, with the finding of the markedly elevated OVA1 value, she was appropriately referred to the gynecologic oncologist for evaluation and surgery.

Patricia Braly, M.D. – Covington, LA – Specialty: Gynecologic Oncology

Case Presentation

A 57-year-old female complained of postmenopausal bleeding at her annual visit. Her bimanual exam was limited by her narrowed vagina and the presence of ascites due to her known primary biliary cirrhosis, for which she was on the liver transplant list.

Clinical Impression

Pelvic ultrasound was performed to evaluate the thickness of her endometrial stripe. It showed a 5cm complex septated left adnexal mass. Ascites was noted. Her endometrium was mildly thickened at 8.7mm. In addition to her primary biliary cirrhosis, the patient had previously been treated with lumpectomy, chemotherapy, and radiation for breast cancer 11 years prior to this exam.

A CA-125 was drawn, returning a score of 70; however this elevation was expected due to her known ascites.

To help ascertain her risk for cancer given this confounding medical condition, an OVA1 was ordered. It was 6.4, which indicated a higher probability for cancer based on a 4.4 cutoff for postmenopausal women. Thus, the patient was referred to a gynecologic oncologist.

Diagnosis

The oncologist started with a laparoscopy due to lowered suspicion of ovarian cancer, but converted to a full ovarian cancer staging surgery upon receiving a cancer diagnosis on frozen section. The patient ended up having a Grade 2 serous adenocarcinoma of the ovary which was intact. Pelvic washings were negative for malignant cells. There was no evidence of metastatic spread and so this was considered a Stage IA Grade 2 disease. The options of expectant management versus adjuvant chemotherapy were offered to her. Her prognosis is guarded and she will have frequent follow-up exams.

Use of OVA1

The OVA1 test results indicated a high likelihood of ovarian cancer based on the predetermined cutoffs. Had the OVA1 score came back below the 4.4 cutoff, the patient likely would not have been referred to the gynecologic oncologist for her surgery. Yet, the elevated OVA1 score helped refer her to the most appropriate surgical setting where she received a complete ovarian cancer staging surgery.

Deborah S. Bredestege, M.D. – Summerville, SC – Specialty: OB/Gyn

Case Presentation

A Caucasian 39-year-old, premenopausal woman went to the emergency room after experiencing pain in her lower left abdomen for three months. She reported no family history of cancer.

Clinical Impression

While at the emergency room a CT scan was run, as well as a transvaginal ultrasound. A complex ovarian cyst was discovered measuring 4.2cm x 2.3cm. The patient was then referred to Dr. Cohen. Since it had been approximately three weeks since her trip to the ER, Dr. Cohen ordered a repeat ultrasound confirming the presence of the mass. Thinking this could be a dermoid, endometriosis or a hemorrhagic cyst, a CA-125 was ordered and it returned at 177, which is under the 200mL cutoff.

Upon receiving her prior records it was learned the patient had an oophorectomy on her right ovary at age 31 for a borderline serous tumor. Taking into account her previous history, and that she was still experiencing pain, Dr. Cohen determined surgery was appropriate and ordered an OVA1 test. The test score came back elevated at 6.0. Based upon the OVA1 score and the overall assessment, the patient was referred to a gynecologic oncologist for surgery. Without the availability of OVA1, Dr. Cohen would have performed an exploratory laparotomy.

Diagnosis

The gynecologic oncologist performed a left ovarian cystectomy which revealed another borderline serous tumor. The patient also wanted to preserve her fertility and therefore her ovary was left intact. The prognosis for her ability to have children is promising.

Use of OVA1

By incorporating OVA1 into the clinical impression the patient was correctly referred to the specialist for her surgery.

Jay Cohen, M.D. – Plantation, FL – Specialty: OB/Gyn

Education for Providers

Review OVA1 Validation Data

OVA1 was rigorously validated to determine its effectiveness for evaluating the risk of ovarian cancer prior to surgery. Review data that reinforces the OVA1 performance.