FISH, PCR, IHC • OncoGxLung™ • mi-LUNG™
FISH, PCR, IHC • OncoGxLung™ • mi-LUNG™
RosettaGX Lung offers a comprehensive lung-specific menu to assist in diagnosis, prognosis, and prediction to therapy for lung cancer patients. This menu includes a full array of lung-specific biomarkers via FISH, PCR, and IHC, OncoGxLung (utilizing NGS), and mi-LUNG, a proprietary microRNA diagnostic test for differentiating between the 4 main subtypes of lung cancer.
Our broad, lung-specific menu is due in large part to the assays developed used FISH, PCR, and IHC methodologies.
FISH: ALK, ROS1, RET, FGFR1, MET
PCR: EGFR, KRAS, BRAF
Rapid turnaround time of 1-4 days
The National Comprehensive Cancer Network (NCCN) recognizes ALK FISH as a specifically designed method for identifying ALK-rearranged lung cancers.1
ALK rearrangements predict likelihood of response to ALK inhibitors such as crizotinib and ceritinib
ROS1 rearrangements predict likelihood of response to ALK inhibitors such as crizotinib and ceritinib
RET rearrangements predict potential response to RET inhibitors such as cabozantinib
FGFR1 amplification allows inclusion in FGFR clinical trials and are typically specific to Squamous Cell subtype in NSCLC
MET amplification predicts potential response to duel ALK / MET inhibitors such as crizotinib, and potential acquired resistance to EGFR TKIs
Predicts likelihood of response to EGFR TKIs: erlotinib, gefitinib, afatinib
Predicts potential resistance to EGFR TKIs: erlotinib, gefitinib, afatinib
BRAF mutations predict potential response to BRAF inhibitors such as vemurafenib and dasatinib
PD-L1 expression predicts potential response to immunotherapy such as nivolumab and pembrolizumab
Soda M, Choi Yl, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007;448(7153):561-566.
Horn L, Pao W. EML4-ALK: honing in on a new target in non-small-cell lung cancer. J Clin Oncol. 2009;27(26):4232-4235.
Shaw At, Yeap By, Mino-Kenudson M, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK.J Clin Oncol. 2009;27(26):4247-4253.
Kwak El, Bang Y-J, Camidge Dr, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010;363(18):1693-703.
Mino-Kenudson M, Mark EJ. Reflex testing for epidermal growth factor receptor mutation and anaplastic lymphoma kinase fluorescence in situ hybridization in non-small cell lung cancer. Arch Pathol Lab Med. 2011;135(5):655-664.
Choi Y, Takeuchi K, Soda M, et al. Identification of Novel Isoforms of the EML4-ALK Transforming Gene in Non-Small Cell Lung Cancer. Cancer Res. 2008;68(13):4971-4976
Rodig Sj , Mino-Kenudson M , Dacic S , et al. Unique clinicopathologic features characterize ALK-rearranged lung adenocarcinoma in the western population. Clin Cancer Res. 2009;15(16):5216-5223.
Bergethon K, Shaw A, Ou S, et al. ROS1 Rearrangements Define a Unique Molecular Class of Lung Cancers. J Clin Oncol. 2012;30(8):863-870.
OncoGxLung is a lung-specific panel that detects point mutations, small insertions/deletions, and gene fusions to provide clinically actionable results.*
Interrogates 5 genes associated with highly-prevalent lung cancer types: EGFR, ROS1, ALK, KRAS, and BRAF
Identifies mutations in exons 18, 19, 20 and 21 of EGFR and exons 2 and 3 of KRAS
Covered by most payers as testing results in cost-effective care decisions
Rapid turnaround time of 7-10 days
This test is a cutting-edge molecular diagnostic test that uses microRNA to accurately differentiate the 4 main histological subtypes of lung cancer, helping clinicians make informed patient care decisions.
8 microRNA biomarkers are used to differentiate small cell lung cancer (SCLC), carcinoid, squamous non-small cell lung cancer (NSCLC), and non-squamous NSCLC
Provides a differential diagnosis with fast, standardized, and objective classification
Validation determined the test's sensitivity and specificity to be 94% and 98%, respectively, for the identification of the 4 main histological subtypes of lung tumors4
The test can be performed on cytological or pathological samples
Rapid turnaround time of 4-7 days
Gilad S, Lithwick-Yanai G, Barshack I, et al. Classification of the Four main Types of Lung Cancer Using a microRNA-Based Diagnostic Assay. J Mol Diagn. 2012;14(5):510-517.
Bishop J, Benjamin H, Cholakh H, Chajut A, Clark D, Westra W. Accurate Classification of Non-Small Cell Lung Carcinoma Using a Novel microRNA-Based Approach. Clin Cancer Res. 2010;16(2):610-619.
Lebanony D, Benjamin H, Gilad S, et al. Diagnostic Assay Based on hsa-miR-205 Expression Distinguishes Squamous From Nonsquamous Non-Small Cell Lung Carcinoma. J Clin Oncol. 2009;27(12):2030-2037.
Barshack I, Lithwick-Yanai G, Afek A, et al. microRNA expression differentiates between primary lung tumors and metastases to the lung. Pathol Res Pract. 2010;206(8):578-584.
Meiri E, Spector Y, Cohen L, et al. microRNAs as powerful diagnostic tools for the differential diagnosis of lung tumors. J Clin Oncol. 2008;26(15S):11112.
Rosenfeld N, Aharonov R, Meiri E, et al. microRNAs accurately identify cancer tissue origin. Nat Biotechnol. 2008;26(4):462-469.
Rosenwald S, Meiri E, Gilad S, et al. MicroRNA signature identifies tissue origin of primary and metastatic tumors. J Clin Oncol. 2008;26(15S):11028.
Liang Y. An expression meta-analysis of predicted microRNA targets identifies a diagnostic signature for lung cancer. BMC Med Genomics. 2008;1(1):61.
Markou A, Tsaroucha E, Kaklamanis L, Fotinou M, Georgoulias V, Lianidou E. Prognostic value of mature microRNA-21 and microRNA-205 overexpression in non-small cell lung cancer by quantitative real-time RT-PCR. Clin Chem. 2008;54(10):1696-1704.
Field RW, Smith BJ, Platz CE, et al. Lung cancer histologic type in the surveillance, epidemiology, and end results registry versus independent review. J Natl Cancer Inst. 2004;96(14):1105-1107.
Stang A, Pohlabeln H, Müller KM, Jahn I, Giersiepen K, Jöckel KH. Diagnostic agreement in the histopathological evaluation of lung cancer tissue in a population-based case-control study. Lung Cancer. 2006;52(1):29-36.
Hammar S. Immunohistology of lung and pleural neoplasms. In: Dabbs D, ed. Diagnostic Immunohistochemistry. 2nd ed. Philadelphia, PA: Churchill Livingstone; 2006:329-403.
Camilo R, Capelozzi V, Siqueira S, Del Carlo Bernardi F. Expression of p63, keratin 5/6, keratin 7, and surfactant-A in non-small cell lung carcinomas. Hum Pathol. 2006;37:542-546.
Reis-Filho J, Simpson Pt, Martins A, Preto A, Gärtner F, Schmitt F. Distribution of p63, cytokeratins 5/6 and cytokeratin 14 in 51 normal and 400 neoplastic human tissue samples using TARP-4 multi-tumor tissue microarray. Virchows Arch. 2003;443:122-132.
Ordóñez NG. The diagnostic utility of immunohistochemistry in distinguishing between epithelioid mesotheliomas and squamous carcinomas of the lung: a comparative study. Mod Pathol. 2006;19(3):417-428.
Au NH, Gown AM, Cheang M, et al. P63 expression in lung carcinoma: a tissue microarray study of 408 cases. Appl Immunohistochem Mol Morphol. 2004;12(3):240-247.
Saad RS, Liu YL, Han H, Landreneau RJ, Silverman JF. Prognostic significance of thyroid transcription factor-1 expression in both early-stage conventional adenocarcinoma and bronchioloalveolar carcinoma of the lung. Hum Pathol. 2004;35(1):3-7.
Abutaily AS, Addis BJ, Roche WR. Immunohistochemistry in the distinction between malignant mesothelioma and pulmonary adenocarcinoma: a critical evaluation of new antibodies. J Clin Pathol. 2002;55(9):662-668.
Tan D, Li Q, Deeb G, et al. Thyroid transcription factor-1 expression prevalence and its clinical implications in non-small cell lung cancer: a high-throughput tissue microarray and immunohistochemistry study. Hum Pathol. 2003;34(6):597-604.
*OncoGxLung is performed by and intrepreted by Admera Health