2012;5(1):35-41. Data were analyzed from December 10, 2018, through June 23, 2019. Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Fort Washington, PA: NCCN; 2018. 2003;88(7):1091-1094. Annual Meeting of the American Urological Association. Future benefits and cost-effectiveness of prostate carcinoma screening. Eur J Cancer. Finally, intrinsic subtype and ROR-P provided independent prognostic information beyond clinicopathological variables and type of pathological response. J Clin Oncol. Erickson BK, Kinde I, Dobbin ZC, et al. Prabhakar K, Rodrίguez CI, Jayanthy AS, et al. Littrup PJ. Conversely, nearly all variants or fusions detected by XA were confirmed by an alternative method. Gynecol Oncol Rep. 2018;23:41-44. Canfield S, Kemeter MJ, Hornberger J, Febbo PG. 2019;14(2):255-264. The authors stated that 1 drawback of this review was the lack of standardization of ctDNA detection methods between studies. Endoscopic ultrasound fine needle aspirate DNA analysis to differentiate malignant and benign pancreatic masses. 2011;96(11):3390-3397. Novel candidate genes may be possible predisposing factors revealed by whole exome sequencing in familial esophageal squamous cell carcinoma. Basal-like, Luminal A, Luminal B, and HER2-enriched subtypes represented 32.7 %, 30.6 %, 18.2 %, and 10.3 % of cases, respectively. A subset of patients had concurrent tissue NGS testing using a 468-gene panel (n = 106). Hong Kong Med J. 2017;132:152-160. 2019;103(1):84-91. Active surveillance for the management of localized prostate cancer (Cancer Care Ontario Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. Although risk-prediction models have been developed for solitary pulmonary nodules, there are no validated models for patients undergoing diagnostic bronchoscopic examination, which includes patients with a broad range of findings, including larger lesions (i.e., greater than 3 cm), infiltrates, or lymphadenopathy. Hybrid capture-based genomic profiling of circulating tumor DNA from patients with advanced non-small cell lung cancer. American College of Obstetricians and Gynecologists (ACOG). Thyroid. The value of the PCA3 assay in guiding decision which men with a negative prostate biopsy need immediate repeat biopsy: Preliminary European data. Results are very variable within runs with the same antibody and between runs on different days. Sixth, the survival outcomes were only available in one of the data-sets evaluated. 2003;44:8-16. Version 1.0. 2017;11(9-10). American Urological Association (AUA) / American Society for Radiation Oncology (ASTRO) / Society of Urologic Oncology (SUO). Fort Washington, PA: NCCN; 2018. Clinical practice guidelines for the use of tumor markers in breast and colorectal cancer. Zumsteg ZS, Spratt DE, Pei I, et al. Accessed July 20, 2018. Bast RC Jr, Brewer M, Zou C, et al. Chang MC, Souter LH, Kamel-Reid S, et al. 2016;26(1):1-133. Prognostic significance of Gleason score discrepancies between needle biopsy and radical prostatectomy. Immunohistochemistry (IHC) is used in histology to detect the presence of specific protein markers that can assist with accurate tumor classification and diagnosis. Scher HI, Lu D, Schreiber NA, et al. Andreopoulou E, Yee H, Warycha MA, et al. Glas A S, Roos D, Deutekom M, et al. 2005;24(1):56-61. Modern chromogenic detection utilizes enzymes such as Horseradish Peroxidase (HRP) that are conjugated (joined) to an antibody. Primary dermal melanoma: A unique subtype of melanoma to be distinguished from cutaneous metastatic melanoma: A clinical, histologic, and gene expression-profiling study. Cohen SJ, Punt CJ, Iannotti N, et al. 2020 Jul 29. Micrometastases or isolated tumor cells and the outcome of breast cancer. J Clin Oncol. Collaborative Initiative of the American Urological Association and the Society of Abdominal Radiology’s Prostate Cancer Disease-Focused Panel. Sidiropoulos M, Obregon R, Cooper C, et al. 1994;12(3):1-30. J Am Acad Dermatol. Technology Evaluation Center (TEC). Rectal cancer. 2018;154(3):491-500. These researchers stated that more studies are needed to assess the sensitivity and specificity of this test in various melanocytic proliferations. Morabito A, Magnani E, Gion M, et al. ctDNA was quantified in the pre-operative and post-operative settings of stages I to III CRC by personalized multiplex, PCR-based, next-generation sequencing. These researchers developed an ultra-deep plasma NGS assay for patients with NSCLC that could detect targetable oncogenic drivers and resistance mutations in patients where tissue biopsy failed to identify an actionable alteration. Rozenblum AB, Ilouze M, Dudnik E, et al. 2009;15(22):7003-7011. Mol Diagn Ther. 3rd ed. 2007;174:91-100. Obstet Gynecol. HSAC Report. [Prognostic genomic tests in early breast cancer: MammaPrint® and Oncotype DX®]. Oncotarget. These methods can vary greatly in cost, and not all technologies are available in standard laboratories. The detection system builds on the secondary. Fort Washington, PA: NCCN, 2018. Am J Surg Pathol. Badani K, Thompson DJ, Buerki C, et al. CNI scores have also been shown to predict therapeutic responses to immunotherapy. Myeloproliferative neoplasms (MPN) - additional molecular testing using multi-gene NGS panel should be considered to evaluate for higher-risk mutations associated with disease progression in patients with primary myelofibrosis (PMF). National Comprehensive Cancer Network (NCCN). Br J Cancer. Among patients who tested plasma NGS positive, 89.6 % (60/67; 95 % CI: 79.7 % to 95.7 %) were also concordant on tissue NGS and 60.6 % (60/99; 95 % CI: 50.3 % to 70.3 %) vice-versa. Furthermore, National Comprehensive Cancer Network’s clinical practice guideline on "Breast cancer" (Version 2.2020) does not mention the use of circulating cell-free DNA as a management tool. Evidence-based Series #2-25: Section 1. Adopted on November 7, 1997 by the American Society of Clinical Oncology. Such phenomenon may explain some discrepancies among BRAF V600E variants detected by qPCR that were negative by immunohistochemistry. Preoperative carcinoembryonic antigen predicts outcomes in node-negative colon cancer patients: A multivariate analysis of 572 patients. 2001;19(6):1865-1878. Gastman BR, Gerami P, Kurley SJ, et al. 2003;37(4):871-879. Azim HA Jr, Michiels S, Zagouri F, et al. A total of 21 novel markers were identified from the 28 novel marker studies. Kau SY, Shyr YM, Su CH, et al. The table below indicates the four risk classes of medical devices. Biosci Rep. 2019;39(6):BSR20190904. Blinded to tissue genotype, plasma NGS sensitivity for de-novo plasma detection of known oncogenic drivers was 75 % (68/91). Prospective validation of the prognostic 31-gene expression profiling test in primary cutaneous melanoma. Version 6.2020. The FDA is requiring the manufacturer to conduct two post-approval studies. NCCN Clinical Practice Guidelines in Oncology, Version 2.2013. Medtech Innovation Briefing 44. Association of AR-V7 on circulating tumor cells as a treatment-specific biomarker with outcomes and survival in castration-resistant prostate cancer. Med Oncol. National Comprehensive Cancer Network (NCCN). 2012;23(8):2046-2052. It can be used for individuals with stage II/III colorectal cancer who are considering adjuvant chemotherapy (ACT) and/or who are being monitored for relapse post-treatment. Definitions and standards in the diagnosis and treatment of the myelodysplastic syndromes: Consensus statements and report from a working conference. J Thorac Oncol. Eur Urol. Breast cancer. RRM1 expression and clinical outcome of gemcitabine-containing chemotherapy for advanced non-small-cell lung cancer: A meta-analysis. For blood-based genomic profiling, next-generation sequencing (NGS) and droplet digital PCR (ddPCR) have been successfully applied. Stewart GD, Van Neste L, Delvenne P, et al. Molecular analysis of multifocal papillary thyroid carcinoma. These tumors represent a high-risk subgroup of MIBC, which may require different treatment. 'Very big deal': NCCN okays watching more prostate cancer. Stable peptide of the endogenous opioid enkephalin precursor and breast cancer risk. Mejia A, Schulz S, Hyslop T, et al. J Urol. Cristofanilli M, Budd GT, Ellis MJ, et al. Ann Oncol. Waltham, MA: UpToDate; June 2015. NCCN Biomarkers Compendium. Hepatobiliary cancers. Local Coverage Determination (LCD): MolDX: Breast Cancer Index℠ Genetic Assay (L35294). NEJM. 2019;5(12):1710-1717. Reece M, Saluja H, Hollington P, et al. This is a process known as double staining. Coates AS, Winer EP, Goldhirsch A, et al. Health Technol Assess. Sum of peak intensities outperforms peak area integration in iTRAQ protein expression measurement by LC-MS/MS using a TripleTOF 5600+ platform. An NGS panel was developed targeting 11 driver oncogenes found in NSCLC. Clin Cancer Res. NCCN Clinical Practice Guidelines in Oncology, version 2.2020. In 127 assessable patients, plasma NGS detected driver mutations with variant allele fractions ranging from 0.14 % to 52 %. 2013;128(2):252-259. AHRQ Publication No. Bubendorf L, Grilli B, Sauter G, et al. Indicators of recurrence following cryotherapy for hepatic metastases from colorectal cancer. These researchers described the detection and quantification of breast-derived cfDNA using a breast-specific DNA methylation signature. Silver Spring, MD: FDA; November 15, 2017. Abstrac 1709. National Comprehensive Cancer Network (NCCN). Links to various non-Aetna sites are provided for your convenience only. Overview of the initial evaluation, diagnosis, and staging of patients with suspected lung cancer. Davis R, Jones JS, Barocas DA, et al. OmniSeq and LabCorp Launch OmniSeq Advance℠ Assay [website]. J Clin Oncol. 2009;94(6):2092-2098. American Urological Association (AUA) and Society of Abdominal Radiology (SAR) Joint Consensus Statement. Prognostic gene expression profiling in cutaneous melanoma: Identifying the knowledge gaps and assessing the clinical benefit. Ann Intern Med. Genomic prostate cancer classifier predicts biochemical failure and metastases in patients after postoperative radiation therapy. FDA clears test that helps identify type of cancer in tumor sample. Bates SE. 2004;1(5). Wu Z, Xu Z, Yu B, et al. To address this question, these investigators developed a hybrid-capture NGS panel utilizing unique molecular identifiers (UMIs) to detect variants at 0.1 % variant allelic frequency (VAF) or below across 22 genes frequently mutated in myeloid disorders and applied it to a retrospective sample set of blood and bone marrow DNA samples previously evaluated as negative for disease via standard-of-care short tandem repeat (STR)-based engraftment testing and hematopathology analysis in the authors’ laboratory. Fort Washington, PA: NCCN; 2020. NCCN Clinical Practice Guidelines in Oncology, Version 2.2015. Campesato LF, Barroso-Sousa R, Jimenez L, et al. Int J Hyg Environ. FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer. D-02-03. 2005;12 Suppl 1:40-43; discussion 99-100. They stated that mechanistically, this study demonstrated that lncRNAs in exosomes could be a promising bio-indicator for the diagnosis and prognosis of solid tumors. 2016;197(1):122-128. Health Technol Assess. Diagnosis of metastatic neoplasms: molecular approaches for identification of tissue of origin. National Institute for Health and Care Excellence (NICE). Aubry W, Lieberthal R, Willis A, et al. Cochrane Database Syst Rev. 2014;74(3):250-259. Oellerich et al (2017) stated that high-quality genomic analysis is critical for personalized pharmacotherapy in patients with cancer. Pre-treatment breast cfDNA was detected in patients with localized disease with a sensitivity of 80 % at 97 % specificity. 2007;13(3):939-943. 2009;117(3):217-227. : MOAC-4. Clin Biochem. 2009;27(15):2503-2508. Ann Intern Med. In the present study, after peptide and protein identification, these researchers compared the widespread quantitation method based on the calculation of LC-MS/MS reporter ion peaks areas ratios (ProteinPilot) to the alternative method based on the calculation of ratios of the sum of peak intensities (jTRAQx [Quant]) and they processed output data with the in-house Customizable iTRAQ Ratios Calculator (CiR-C) algorithm. Blood. 2004;351(27):2817-2826. Groskopf J, Nakanishi H, Deras IL, et al. Am J Pathol. J Urol. De Giorgi U, Valero V, Rohren E, et al. How do I recommend extended adjuvant hormonal therapy? Detection of rare reciprocal RUNX1 rearrangements by next-generation sequencing in acute myeloid leukemia. JCI Insight. Furthermore, guidelines from the National Comprehensive Cancer Network (NCCN, 2010) recommend EGFR testing for the following histologic subtypes of NSCLC: Wu and colleagues (2011) noted that PSA screening has low specificity. Topographic genotyping of colorectal carcinoma: From a molecular carcinogenesis model to clinical relevance. CALCA (calcitonin) expression for medullary thyroid cancer or for adenocarcinoma or anaplastic/undifferentiated tumors of the head and neck. Androgen receptor splice variant 7 (AR-V7) and drug efficacy in castration-resistant prostate cancer: Biomarker for treatment selection exclusion or inclusion? Shimamura T, Sakamoto M, Ino Y, et al. J Clin Oncol. Measurement of des-gamma-carboxy prothrombin levels in cancer and non-cancer tissue in patients with hepatocellular carcinoma. Eur Urol. The advantages of RTUs include increased laboratory efficiency, better quality control, and easier reagent management. In addition, because of inherent sampling errors with biopsy results, further comparison to final surgical pathology should be made. Waltham, MA: UpToDate; reviewed January 2015. NCCN Clinical Practice Guidelines in Oncology, version 1.2020. 2015;1(5):577-579. Ohori NP, Nikiforova MN, Schoedel KE, et al. NCCN: Fort Washington, PA. National Comprehensive Cancer Network (NCCN). Gastrointest Endosc. National Comprehensive Cancer Network (NCCN). Part I: Risk Stratification, Shared Decision Making, and Care Options. ctDNA detection was lower in patients who were on systemic therapy at the time of plasma collection compared with those who were not (30/70, 42.9 % versus 105/140, 75.0 %; OR = 0.26, 95 % CI: 0.1 to 0.5, p < 0.001). CellSearch™ [website]. Tumour markers for prediction of survival and monitoring of remission in small cell lung cancer. 2014;17(1):64-69. The combined apparent false-positive and negative rates of the Sentinel HG Test with biopsy outcome is around 10 %. 2012;11:147-156. Curr Opin Ophthalmol. Neoadjuvant treatment of colorectal cancer with bevacizumab: The perioperative angiogenic balance is sensitive to systemic thrombospondin-1 levels. 2003;23:305-308. Vege SS, Ziring B, Jain R, Moayyedi P; Clinical Guidelines Committee. Identification of high-risk cutaneous melanoma tumors is improved when combining the online American Joint Committee on Cancer Individualized Melanoma Patient Outcome Prediction Tool with a 31-gene expression profile-based classification. Fort Washington, PA: NCCN; 2019. These researchers stated that in this preliminary study, they provided proof of the concept that breast cfDNA quantification opens a window into the dynamics of breast cancer with a potential for early diagnosis, monitoring of treatment response, and detection of recurrence. Decipher test impacts decision making among patients considering adjuvant and salvage treatment after radical prostatectomy: Interim results from the multicenter prospective PRO-IMPACT study. These investigators also observed a shift towards tetrahydro-corticosterone, cortisol and etiocholanolone production in patients. Head and neck cancers. Pricolo VE, Finkelstein SD, Bland KI. PLoS One. Breast Cancer. Int J Biol Markers. Sensitivity, specificity, and negative predictive value (NPV) were calculated. Repeat testing is considered experimental and investigational, TP53 for chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, splenic marginal zone lymphoma, acute myeloid leukemia, occult primary, and myelodysplastic syndromes. Matritech, Inc. [website]. NIHR HSC. 2006;24(31):5091-5097. Habel LA, Shak S, Jacobs MK, et al. 2008;26(19):3213-3221. J Clin Oncol. National Comprehensive Cancer Network. Central nervous system cancers. The detection of variants using NGS changed the diagnosis of 7 patients and the prognosis of 15 patients and enabled these investigators to identify 44 suitable candidates for clinical trials. Waltham, MA: UpToDate; reviewed January 2015. NCCN Clinical Practice Guidelines in Oncology, Version 2.2018. 2018;18(1):130. Klein EA, Santiago-Jiménez M, Yousefi K, et al. Analytical validity of a microRNA-based assay for diagnosing indeterminate thyroid FNA smears from routinely prepared cytology slides. Morash C, Tey R, Agbassi C, et al. al. 2006;101(11):2493-2500. Clinical tumour markers in ovarian cancer. Decipher genomic classifier measured on prostate biopsy predicts metastasis risk. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Patients with NE-like tumors had significantly worse 1-year PFS (65 % NE-like versus 82 % overall; p = 0.046) and, after adjusting for clinical and pathologic factors, had a 6.4-fold increased risk of all-cause mortality (p = 0.001); IHC confirmed the neuronal character of these tumors. CFL1 expression levels as a prognostic and drug resistance marker in nonsmall cell lung cancer. Stoyanova R, Pollack A, Takhar M, et al. Gynecol Oncol. Aureon Laboratories, Inc. Aureon Laboratories announces name change for existing post-surgical prostate cancer recurrence test commercially available since February 2006, Post-Op Px(TM) is the first diagnostic test to predict prostate cancer recurrence. Marks LS, Fradet Y, Deras IL, et al. NSCLC, colorectal cancer, pancreatic ductal adenocarcinomas). PubMed, Embase, the Cochrane Library, and Web of Science were searched to identify the studies that reported the function of ctDNA for predicting recurrence in CRC patients. Madrid, Spain: Plan de Calidad para el SNS del MSPSI, Unidad de Evaluación de Tecnologías Sanitarias, Agencia Laín Entralgo; 2010. Intensified adjuvant therapy for pancreatic and periampullary adenocarcinoma: Survival results and observations regarding patterns of failure, radiotherapy dose and CA19-9 levels. Ross DS. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. In 2 cases with incomplete tumor genotyping, plasma NGS rapidly identified a novel EGFR exon 19 deletion and a missed case of MET amplification. Prepared by the Tufts Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) under Contract No. NCCN Clinical Practice Guidelines in Oncology, Version 6.2020. Finally, research should be devoted to further characterize the small noncoding RNAs as they may provide additional insights and/or therapeutic targets into the biology of PCa". Cancer antigen 125 (CA 125) levels for any of the following: In members with known ovarian cancer, as an aid in the monitoring of disease, response to treatment, detection of recurrent disease, or assessing value of performing second-look surgery, CHGA (Chromogranin A) expression for neuroendocrine tumors, non-small cell lung cancer, Merkel cell carcinoma and occult primary. Balancing confounding and generalizability using observational, real-world data: 17-gene genomic prostate score assay effect on active surveillance. 2019;7(6):487-496. PLoS One. Albain KS, Barlow WE, Shak S, et al; Breast Cancer Intergroup of North America. The IHC Membrane App unmixes up to three markers in an IHC or HC digital slide and segments cells into nucleus, and/or perinuclear area and/or cytoplasm, as well as into membrane (e.g. Boström PJ, Bjartell AS, Catto JW, et al. UpToDate [online serial]. Waltham, MA: UpToDate; 2008. 2019;17(1):181. Performance of a prognostic 31-gene expression profile in an independent cohort of 523 cutaneous melanoma patients. Zhou C, Yuan Z, Ma W, et al. Br J Dermatol. The authors concluded that the findings of this study suggested that ctDNA analysis after surgery is a promising prognostic marker in stage III colon cancer. Onken MD, Worley LA, Char DH, et al. Wang XT, Kong FB, Mai W, et al. Breast Cancer Res. The “CellSearch” System for Detecting Circulating Tumour Cells in Advanced Ovarian Cancer: Clinical Benefit and Cost-Effectiveness. Eur Urol. Cancer. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Jones MW, Kounelis S, Papadaki H, et al. Precis Cancer Med. Exosomal and non-exosomal urinary miRNAs in prostate cancer detection and prognosis.
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