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DESCRIPTIONThe genetic basis of cancer has been an intense research focus; however, 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. Research interest has been increasing in the field of proteomics (referring to the protein product of the genome), in an effort to improve upon screening and detection efforts for malignancies.
Serum protein biomarkers
Current diagnostic and follow-up serum biomarkers in clinical oncology (e.g., prostate specific antigen [PSA, prostate cancer], CA-125 [ovarian cancer]), involve identifying and quantifying specific proteins, but limitations may include non-specificity and elevation in benign conditions.
Ovarian cancer is the leading cause of death from gynecologic malignancy in the U.S., as most patients present with advanced disease with a 5-year survival rate between 15–45%. However, if the disease is caught in Stage I, survival rates are 95%. Therefore, there is great interest in a biomarker to detect ovarian cancer in its earliest stages, as current screening methods are inadequate.
Serum measurements of PSA are used as a screening method for detecting prostate cancer. Very low or very high serum PSA results are most reliable in determining cancer risk. However, values often fall within a range that is nonspecific, and thus many patients end up undergoing biopsy for benign disease. Proteomics has been proposed as a technique to further evaluate cancer risk in this diagnostic "gray" zone.
Proteomics involves the use of mass spectometry to study differences in patterns of protein expression. While patterns of protein expression have been proposed to yield more biologically relevant and clinically useful information than assays of single proteins, many limitations in the use of proteomics exist. In contrast to genomics, where amplification techniques like polymerase chain reaction (PCR) allow for the investigation of single cells, no technology is available at the protein level. Other issues between studies have been lack of uniform patient inclusion and exclusion criteria, small patient numbers, absence of standardized sample preparations and limited analytical reproducibility.
Correlogic Systems, Inc. has developed a serum-based test using proteomics for the early detection of epithelial ovarian cancer called OvaCheck®. The test 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.
Originally, the manufacturer had assumed that the test would not be subject to approval by the U.S. Food and Drug Administration (FDA), since the test would be performed exclusively at one reference laboratory and testing materials do not cross state lines (i.e., a "home brew" test). However, in 2004, the FDA determined that the software used to perform the analysis was considered a medical device and under the FDA premarket review jurisdiction. At this time, Correlogics is conducting clinical trials on OvaCheck® at sites in the U.S. and abroad, and it is not commercially available.
Correlogics is also in the process of developing proteomic blood tests for the detection of colorectal, breast (MammoCheck®) and prostate cancer (ProstaCheck®).
Proteomic testing is not commercially available at this time.
POLICYAnalysis of proteomic patterns in serum for screening and detection of cancer is considered investigational.
There is no specific code for the OvaCheck test.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY10/3/2006: Policy added
9/18/2007: Policy reviewed, no changes
6/26/2009: Policy Description section changed
09/25/2012: Policy title changed from "Analysis of Proteomic Patterns in Serum to Identify Cancer" to "Analysis of Proteomic Patterns for Early Detection of Cancer." Policy statement unchanged.
07/02/2015: Code Reference section updated for ICD-10.
06/07/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.04.34
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.