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What is an adnexal mass and does it mean I have cancer?

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Assessing a pelvic mass
What are the testing options available for pelvic masses?

Testing an indeterminate or likely benign pelvic mass
Which test should I use if an unknown mass has been identified?

Testing a pelvic mass with planned surgery
Which test should I use to assess my risk of malignancy before surgery?

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Transforming Gynecologic Care
Through AI-powered Diagnostics

We are revolutionizing women’s health through innovative testing options, leveraging a data-driven approach to empower patients and healthcare providers in achieving optimal gynecologic care.

Advancing Women’s Health Starts
with Groundbreaking Research

We combine cutting-edge technology with clinical expertise to develop innovative testing solutions. Our research efforts are dedicated to improving women's lives through earlier risk assessment, more accurate diagnoses, and personalized care strategies through rigorous scientific investigation.

peer-reviewed publications

Years of experience leveraging AI to develop Aspira's products, offering personalized risk assessment scores

tests ordered by healthcare providers

OvaSuiteSM: A Comprehensive Portfolio
of Non-invasive Ovarian Care Solutions

Planned for Clinical Management

For adnexal masses initially evaluated as indeterminate or benign
Negative Predictive Value of over 99%1
Longitudinal monitoring feature to help providers track risk over time

Learn More

Planned for Surgical Management

For adnexal masses that are planned for surgery
Ova1® has a sensitivity of over 96% with clinical assessment2
Biomarkers (including CA-125), menopausal status, and ultrasound for a personalized risk score

Ova1Plus is a reflex process: Ova1® is performed3 first. If an intermediate risk is detected, Overa® is automatically performed.

Learn More

A recent study indicates that using OvaWatch could have led to a potential3:

overall reduction in avoidable adnexal mass surgeries

reduction of surgical referrals among asymptomatic patients

reduction of surgical referrals among premenopausal patients

Ova1 Showed Superior Malignancy Risk Detection in Cases Where CA-125 was Uninformative4

Across All Stages

According to a peer-reviewed study, Ova1 showed most cases ovarian cancer risk that were missed by CA-125

Stage I and II

Ova1 detected

of early-stage malignancy risk missed by CA-125

Premenopausal

Ova1 identified

(20/39) of premenopausal cancers for which CA-125 failed to detect malignancy

Postmenopausal

Ova1 identified

(22/37) of postmenopausal cancers for which CA-125 failed to detect malignancy

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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.

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.

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.

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