Test Id : OVAWA
Ovarian Mass Risk Monitoring, OvaWatch, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Serial monitoring and risk assessment for ovarian malignancy in women who present with an adnexal mass clinically assessed as indeterminate or benign
Highlights
OvaWatch is a non-invasive lab blood test to determine the risk of ovarian cancer in conjunction with clinical assessment for patients with an adnexal mass. OvaWatch utilizes a neural network-based algorithm combining serum biomarkers and clinical covariates (CA-125 II, prealbumin, apolipoprotein A1, beta2-microglobulin, transferrin, follicle-stimulating hormone, human epididymis protein 4, age and menopausal status) to examine malignancy risk with individuals with an adnexal mass.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For information see Clinical Triage for Adnexal Masses
Method Name
A short description of the method used to perform the test
Immunoassay/Multivariate Index Assay/Electrochemiluminescence Immunoassay (ECLIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Multivariate Index Assay
Immunoassay
CA-125 II
Prealbumin
Apolipoprotein A-1
Beta2-microglobulin
Transferrin
Follicle Stimulating Hormone
Human Epididymis Protein 4
Aspira
Aspira Women's Health
OvaWatch
Adnexal Mass
Menopause
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For information see Clinical Triage for Adnexal Masses
Specimen Type
Describes the specimen type validated for testing
Serum
Ordering Guidance
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 as indeterminate or benign.
Shipping Instructions
1. Specimens sent refrigerated must reach Mayo Clinic Laboratories within 4 days of collection.
2. Specimens sent frozen must be shipped on dry ice.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| OVAW1 | Menopausal Status |
Pre Post |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Collection Container/Tube: Sarstedt Aliquot Tube, 5 mL (T914)
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL Serum
Collection Information:
1. Allow the specimen to clot for at least 30 minutes.
2. Within 2 hours of collection, centrifuge the specimen.
3. For serum gel tubes, aliquot serum into a plastic vial or send centrifuged serum gel tube.
4. For red top tubes, aliquot serum into a plastic vial within 10 minutes of centrifugation.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Serum 1.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 8 days | |
| Frozen | 90 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Serial monitoring and risk assessment for ovarian malignancy in women who present with an adnexal mass clinically assessed as indeterminate or benign
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
For information see Clinical Triage for Adnexal Masses
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
OvaWatch employs a combination of age, menopausal status, and serum protein biomarkers with a proprietary algorithm to provide a personalized risk assessment. OvaWatch performance characteristics were established in a study of 2000 women with adnexal mass, in which the ovarian cancer prevalence was 4.9%. OvaWatch specificity was validated at 84% with negative predictive value of 99.4%, whereas its sensitivity was validated at 90% (98.0% for Stage 3 and 4 and 76.9% for Stage 1 and 2 cancers) with positive predictive value of 22.5%.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
An interpretive report will be provided
Interpretation
Provides information to assist in interpretation of the test results
A low-risk score is highly suggestive of a benign mass (less than 5.0% probability of cancer).
An indeterminate score suggests that presence of cancer cannot be ruled out.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
OvaWatch results should always be interpreted in combination with clinical assessment, personal history, and imaging studies.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Reilly G, Bullock RG, Greenwood J, et al. Analytical validation of a deep neural network algorithm for the detection of ovarian cancer. JCO Clin Cancer Inform. 2022;6:e2100192. doi:10.1200/CCI.21.00192
2. Dearking AC, Aletti GD, McGree ME, Weaver AL, Sommerfield MK, Cliby WA. How relevant are ACOG and SGO guidelines for referral of adnexal mass?. Obstet Gynecol. 2007;110(4):841-848. doi:10.1097/01.AOG.0000267198.25223.b
3. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Gynecology. Practice Bulletin No. 174: Evaluation and Management of Adnexal Masses. Obstet Gynecol. 2016;128(5):e210-e226. doi:10.1097/AOG.0000000000001768
4. Reilly GP, Dunton CJ, Bullock RG, et al. Validation of a deep neural network-based algorithm supporting clinical management of adnexal mass. Front Med (Lausanne). 2023;10:1102437. Published 2023 Jan 23. doi:10.3389/fmed.2023.1102437
5. Roy Choudhury M, Pappas TC, Twiggs LB, Caoili E, Fritsche H, Phan RT. Ovarian cancer surgical consideration is markedly improved by the neural network powered-MIA3G multivariate index assay. Front Med (Lausanne). 2024;11:1374836. Published 2024 May 2. doi:10.3389/fmed.2024.1374836
6. Pappas TC, Roy Choudhury M, Chacko BK, et al. Neural network-derived multivariate index assay demonstrates effective clinical performance in longitudinal monitoring of ovarian cancer risk. Gynecol Oncol. 2024;187:21-29. doi:10.1016/j.ygyno.2024.04.020
Method Description
Describes how the test is performed and provides a method-specific reference
OvaWatch is a laboratory developed qualitative serum test that generates a single numerical score by applying a machine learning algorithm to seven immunoassay results combined with patient age and menopausal status. The biomarkers measured are CA-125 II, prealbumin, apolipoprotein A1, beta-2 microglobulin, transferrin, follicle-stimulating hormone (FSH), and human epididymis protein 4 (HE4). All biomarker values are determined using assays on the Roche cobas, an automated analyzer which uses electrochemiluminescence detection. The biomarker assays are conducted according to the manufacturer's directions as detailed in the Instructions for Use for each product.(Reilly G, Bullock RG, Greenwood J, et al. Analytical validation of a deep neural network algorithm for the detection of ovarian cancer. JCO Clin Cancer Inform. 2022;6:e2100192. doi:10.1200/CCI.21.00192)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday, Wednesday, Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed and its performance characteristics were determined by Aspira Laboratory. The test has not been cleared or approved by the FDA, nor is it required to be. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. The results represent individual analyses for the patient and were obtained from this multivariate index assay should always be interpreted in the context of clinical examination, patient medical history, and other findings.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
0375U
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| OVAWA | OvaWatch, S | Not Provided |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| OVAWR | OvaWatch | Not Provided |