Analysis of Proteomic Patterns in Serum to Identify Ovarian Cancer
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Medical Policy: 02.04.18
Original Effective Date: July 2008
Reviewed:
Revised:
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
Description:
The American Cancer Society (ACS) reports in their Cancer Facts and Figures: An estimated 21,650 new cases of ovarian cancer are expected in the US in 2008. Ovarian cancer accounts for about 3% of all cancers among women and ranks second among gynecologic cancers, following cancer of the uterine corpus. During 1987-2004, ovarian cancer incidence declined at a rate of 0.9% per year. An estimated 15,520 deaths are expected in 2008. Ovarian cancer causes more deaths than any other cancer of the female reproductive system. Only 19 % of ovarian cancers are diagnosed at a localized stage.
Currently there is no accurate screening test available, so routine screening for women at average risk is not recommended. When the disease is advanced, pelvic examination only occasionally detects ovarian cancer. Women who are at high risk of ovarian cancer and women who have persistent, unexplained symptoms may be offered the combination of a thorough pelvic exam, transvaginal ultrasound, and a blood test for the tumor marker CA125. The techniques of CA125 and transvaginal ultrasound have not resulted in a decrease in morbidity, primarily due to the disease stage at presentation and the lack of curative therapies. Transvaginal ultrasound and testing for the tumor marker CA125 may help in diagnosis for women at average risk, but are not used for routine screening.
While research into the genetic basis of cancer has been an intense research focus, genetic mutations do not reflect the complicated interactions between individual cells, tissue, and organs. Proteins are the functional units of cells and represent the end product of the interactions among the underlying genes. Proteomics (to distinguish it from genomics), defined as the study of all protein forms expressed within an organism as a function of time, age, state, and external factors. Essentially, the identification of patterns of proteins in the serum could function as serum tumor marker, similar in concept to the more familiar CA125, which is used in the detection and monitoring of ovarian cancer. This type of proteomic profiling has also been referred to as a “protein fingerprint.”
The OvaCheckTM (Correlogic Systems) is based on proteomic patterns detected in the serum, which are further analyzed with the use of a mass spectrometer to profile a population of proteins based on their size and electrical charge. This type of analysis contains thousands of data points, which undergo further sophisticated computer analysis using artificial intelligence-based algorithms to identify a pattern that is consistent with ovarian cancer. The OvaCheck will be offered exclusively at reference laboratories. The U.S. Food and Drug Administration (FDA) had not planned to regulate the manufacturer (Correlogic) or its laboratory partners, LabCorp and Quest in their ongoing provision of the OvaCheck test. The software is subject to the FDA premarket review. The manufacturer took the software in-house in response to the premarket review requirement. The FDA is considering its responsibilities regarding “home brew” (materials don’t cross state lines) tests.
Policy:
Analysis of proteomic patterns in serum for screening and detection of ovarian cancer is considered investigational.
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Procedure Codes and Billing
Guidelines:
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To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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There is no specific code for the OvaCheck test. CPT code 83789 describes quantitative mass spectrometry, which might apply to the initial step of the OvaCheck test, or other variants of proteomics.
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Selected References:
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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