OVA1 is a Multivariate Index Assay (MIA) developed to evaluate pelvic masses for patients not yet referred to an oncologist.
OVA1/MIA combines the results of five immunoassays associated with ovarian cancer (CA 125 II, transferrin, transthyretin [prealbumin], apolipoprotein A-1, and β 2-microglobulin) into a numerical score of 0-10 using a proprietary algorithm. OVA1/MIA is intended for use in combination with a physician assessment and imaging results, and to ultimately increase the number of patients detected in an early stage and to more effectively manage the number of patients with a low risk of malignancy being referred to gynecologic oncologists.
Clinical Assessment and OVA1
The clinical performance of OVA1 (MIA) has been validated in combination with an independent clinical assessment. Once a pelvic mass is identified and planned for surgery, the assessment of the patient’s history, imaging, and OVA1 (MIA) score is triggered. If a modality indicates elevated risk, physicians can be confident in the sensitivity to detect ovarian cancer. If the modalities agree on a low risk, you can feel more assured that it is unlikely cancer. Based on the data from OVA1 (MIA) validation studies, we recommend the risk assessment protocol outlined below.
OVA1 (MIA) should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of OVA1 (MIA) carries the risk of unnecessary surgery and/or delayed diagnosis.
Identify patients with inconclusive imaging
Imaging may not detect cancer when present. Most ultrasound features are indeterminate and not definitive of cancer.
This uncertainty is often identified as the gray-zone. To be sensitive in detecting ovarian cancer, look for the following gray-zone red flags in your ultrasound reports (table on the right) and evaluate with OVA1 (MIA) pre-surgically.
Gray-zone red flags include:
- Cysts concerning for surgery
- Fixed or bilateral cysts
Complex or suspicious for:
- Think or thick, single or multiple septations
- Non-classic endometrioma, dermoid, hemorrhagic cyst findings
- Thickened walls
- Solid consistency
- Papillary projections
The OVA1 test helped detect malignancy in the earliest stage, which led to the referral of the patient to the specialist and improved her chance of survival.– Thomas Greenwell, M.D.