Developing a New
Standard for Adnexal
Mass Evaluation

OvaPrint is still in clinical validation. Early studies show that OvaPrint delivers significantly superior specificity compared to current options. While CA-125 has approximately 50% specificity and multivariate protein assays like Ova1Plus achieve 72% specificity, OvaPrint targets much higher specificity with a stronger negative predictive value. This dramatic improvement in specificity means far fewer false positives, reducing unnecessary referrals and surgeries while maintaining high sensitivity for high-grade serous ovarian cancer detection.

OvaPrint requires a standard blood draw using 3 PAXgene collection tubes, which we provide in our test kit. The collection process is straightforward—no special fasting or preparation is required.

Our customer service team provides full support for sample collection, handling, and shipping logistics to ensure proper specimen integrity.

Our target turnaround time is about 2 weeks from sample receipt. However, actual turnaround times may be faster as we optimize our laboratory processes. We track turnaround time as a key quality metric and are committed to providing timely results to support clinical decision-making.

OvaPrint is intended for women aged 18 and older who have an adnexal mass, prior to any treatment or surgery. It is designed to help distinguish between malignant and benign disease so patients and physicians can make more informed decisions.

It is particularly valuable for:
1) Patients with indeterminate imaging findings where it is unclear whether a mass is malignant or benign.
2) Situations where physicians are deciding if surgery is needed and, if so, whether a laparoscopy or laparotomy is most appropriate.
3) Helping to determine the appropriate referral pathway (e.g., gynecologist vs. gynecologic oncologist).
4) Premenopausal women for whom fertility preservation is an important consideration.

OvaPrint will initially launch without established insurance coverage, with plans to submit for CMS Local Coverage Determination in 2026. During the pre-coverage period, the test will be available on a self-pay basis.

We're developing patient assistance programs and institutional pricing arrangements to support access during this transition period. We provide resources to help practices discuss the value proposition with patients and explore payment options.

The OvaPrint test will provides a clear, binary result: "High Risk" or "Low Risk" for ovarian malignancy.

A Low Risk result will provide strong confidence that the mass is benign, supporting non-surgical management or routine surveillance. A High Risk result will indicate likely malignancy and support referral to a gynecologic oncologist for surgical planning.

Our detailed test reports will include clinical interpretation guidance, and our medical affairs team will be available for consultative support to help integrate results into your clinical decision-making process.