Ovarian Cancer Risk Assessment for Patients Planned for Surgery

Ova1Plus® is a combination of two FDA- cleared blood tests to detect the risk of ovarian malignancy in women with adnexal masses planned for surgery.*

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Proven Performance with FDA-Clearance

Ova1Plus is a proprietary reflex process combining two FDA-cleared tests, Ova1®, leveraging high sensitivity, and Overa®, leveraging high specificity, for patients with adnexal masses.

High Sensitivity

96% sensitivity when combined with clinical assessment2

Higher Detection

Detects 59% more ovarian cancer risks missed by CA-125 alone4

Early-Stage Detection

Detects 63% of early-stage malignancy risk (Stage I and II) missed by CA-1254

A peer-reviewed study shows Ova1 offers superior performance over CA-125 in identifying early-stage ovarian malignancies2:

sensitivity for early-stage ovarian cancer vs CA-125's 62.8%

sensitivity across all cancer stages vs CA-125’s
70.6%

reduction in missed early-stage cancers vs clinical impression
(5% vs. 31%)

DOWNLOAD THE CLINICAL SUMMARY

Supported By Professional Guidelines

ACOG: LEVEL B – Practice Bulletin 174

Consultation with or referral to a gynecologic oncologist is recommended for women with an adnexal mass who meet one or more of the following criteria:

Premenopausal or postmenopausal women with an elevated score on a formal risk assessment test such as the multivariate index assay (MIA = OVA 1) 5

SGO Position Statement

Tests monitoring blood levels of five proteins may be useful in identifying women with a pelvic mass who should be referred to a gynecologic oncologist.6

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Optimize Surgical Management with Data-Driven Decisions

Utilizing Ova1Plus in practice could:

Enhance confidence in the chosen surgical management plan

Effectively triage higher-risk patients for appropriate referrals

Help improve patient confidence in the chosen surgical plan

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Clinical Advantages for Ease & Convenience

MULTIPLE BIOMARKERS

Our products use an advanced, evidence-based algorithm incorporating multiple biomarkers

OPTIMIZED REPORTS

Based off provider feedback, our reports are even easier-to-read with clear risk scores

SIMPLE & OBJECTIVE

One simple blood draw provides an objective risk score within 48 hours

The Ova1Plus Report

The Ova1Plus report calculates a personalized risk score by combining biomarker measurements (including CA-125), menopausal status, and ultrasound results.

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Refine Your Approach to Adnexal Masses

Unlike single biomarker tests of the past, Ova1Plus offers data-driven insights to complement provider judgment, imaging, and patient history. Our proprietary algorithm includes:

Menopausal status

Ultrasound results

Additional biomarkers (including CA-125)

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Ova1Plus equips healthcare providers with the comprehensive ovarian cancer risk intelligence needed to optimize surgical management plans.

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Not immediately planning for surgery?

Learn about OvaWatch

References

Reilly, G., Bullock, R. G., Greenwood, J., Ure, D. R., Stewart, E., Davidoff, P., ... & Northrop, L. E. (2022). Analytical validation of a deep neural network algorithm for the detection of ovarian cancer. JCO Clinical Cancer Informatics, 6, e2100192.
Bristow, R. E., Smith, A., Zhang, Z., Chan, D. W., Crutcher, G., Fung, E. T., & Munroe, D. G. (2013). Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecologic oncology, 128(2), 252-259.
Choudhury, M. Roy, Pappas, T. C., Twiggs, L. B., Caoili, E., Fritsche, H., & Phan, R. T. (2024). Ovarian Cancer surgical consideration is markedly improved by the neural network powered-MIA3G multivariate index assay. Frontiers in Medicine, 11, 1374836.
Dunton, C. J., Hutchcraft, M. L., Bullock, R. G., Northrop, L. E., & Ueland, F. R. (2021). Salvaging detection of early-stage ovarian malignancies when CA125 is not informative. Diagnostics, 11(8), 1440.
ACOG Practice Bulletin Number 174, November 2016
SGO Position Statement Issued 2011, Updated 2013
American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 174: Evaluation and Management of Adnexal Masses. Obstet Gynecol. 2016 Nov;128(5):e210-e226. doi: 10.1097/AOG.0000000000001768. PMID: 27776072.
Castillo G, Alcázar JL, Jurado M. Natural history of sonographically detected simple unilocular adnexal cysts in asymptomatic postmenopausal women. Gynecol Oncol 2004; 92:965.
Pavlik EJ, Ueland FR, Miller RW, et al. Frequency and disposition of ovarian abnormalities followed with serial transvaginal ultrasonography. Obstet Gynecol 2013; 122:210.
Ueland, F. R., & Fredericks, N. I. (2018). Ovarian masses: Surgery or surveillance. OBG Manag, 30(6), 17-26.
Cleveland Clinic. (n.d.). Adnexal mass (tumor): Symptoms, causes & treatment. Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/22015-adnexal-mass-tumors
Eskander, R., Berman, M., & Keder, L. (2016). Evaluation and management of adnexal masses. Obstetrics and Gynecology, 128(5), e210-e226.
Alcázar, J. L., Pascual, M. A., Graupera, B., Aubá, M., Errasti, T., Olartecoechea, B., ... & Guerriero, S. (2016). External validation of IOTA simple descriptors and simple rules for classifying adnexal masses. Ultrasound in Obstetrics & Gynecology, 48(3), 397-402.
Kingsberg, S. A., Larkin, L. C., & Liu, J. H. (2020). Clinical effects of early or surgical menopause. Obstetrics & Gynecology, 135(4), 853-868.

* In cases of an intermediate Ova1 result, the FDA-cleared Overa reflex is performed to increase specificity

PRECAUTION: Ova1 and Overa should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

PRECAUTION: OvaWatch is intended for use as a non-invasive test to assess the risk of ovarian cancer for women with adnexal masses, evaluated by initial clinical assessment (ICA) as indeterminate or benign. In conjunction with imaging (ultrasound and/or CT) and clinical assessment, this test will support physicians in making informed clinical decisions in the management of women with adnexal masses. The test is not intended as a screening test or a stand-alone diagnostic assay.

Understanding pelvic masses

Treatment plan options

What to expect

Ongoing support

Assessing a pelvic mass

Testing an indeterminate or likely benign pelvic mass

Testing a pelvic mass with planned surgery

How does the test work?

Ovarian Cancer Risk Assessment for Patients Planned for Surgery

Proven Performance with FDA-Clearance