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

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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

References:

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