Analysis of Proteomic Patterns in Serum to Identify Ovarian Cancer
Medical Policy: 02.04.18
Original Effective Date: July 2008
Reviewed: August 2011
Revised:
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This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
The American Cancer Society (ACS) reports in their Cancer Facts and Figures: An estimated 21,900 new cases of ovarian cancer are expected in the US in 2011. Ovarian cancer is the ninth most common cancer in women (not counting skin cancer) and ranks fifth as the cause of cancer death in women. About half of women diagnosed with ovarian cancer are age 60 and older. A woman’s risk of getting invasive ovarian cancer in her lifetime is about 1 in 71. Her lifetime chance of dying from ovarian cancer is about 1 in 95. Only 20% of ovarian cancers are diagnosed at an early stage. Finding the cancer early improves the chances it can be treated with success. About 9 out of 10 women treated for early ovarian cancer will live longer than 5 years after the cancer is found. Several large studies are underway to determine how best to find ovarian cancer in its earliest stages.
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 CA-125. The techniques of CA-125 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 CA-125 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 CA-125, 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.
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Prior Approval:
Not applicable
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Policy:
Analysis of proteomic patterns in serum for screening and detection of ovarian cancer is considered investigational.
The use of proteomic pattern analysis for the detection of cancer is currently in clinical trials and testing is not commercially available.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, 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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Policy History:
Date Reason Action
August 2011 Annual review Policy renewed
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*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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