Aspira Women's Health Inc. announced its manuscript, entitled: Validation of deep neural network-based algorithm supporting clinical management of adnexal mass, has been published in the prestigious peer reviewed journal, Frontiers in Medicine. The paper presents findings from the multi-site clinical study of the company's new assay, OvaWatch, describing real-world evidence supporting the use of OvaWatch for the clinical management of adnexal masses. Conservative management of adnexal masses is warranted when masses are clinically characterized as benign or indeterminate.

Due to the mortality risk associated with malignancy stemming from a lack of noninvasive diagnostic tools, patients and healthcare providers have often opted for a more aggressive surgical plan resulting in potentially unnecessary surgery, pain for the patient, and cost to an overburdened healthcare system. In this multi-site clinical study, OvaWatch assay, was used to examine malignancy risk in prospective and retrospective samples of patients with an adnexal mass. In retrospective, low prevalence (N=1453, 1.5% malignancy rate) data from patients that received an independent physician assessment of benign, OvaWatch has a sensitivity of 81.8% and specificity of 87.4% for identifying a histologically confirmed malignancy, and a negative predictive value (NPV) of 99.7%.

OvaWatch identified 18/22 malignancies missed by physician assessment. In the prospective real-world data set of 501 patients (2% malignancy rate), the NPV remained at 99%. Additionally, in an independent analysis set with an intentionally high malignancy rate (4%) the NPV was 88%.

The consistently high NPV indicates that OvaWatch can aid clinicians in the management of women with an adnexal mass helping to add assurance that a mass has low probability of malignancy.