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.

FISH, PCR, IHC

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

IHC: PD-L1

PCR: EGFR, KRAS, BRAF

Rapid turnaround time of 1-4 days

NCCN-Recognized
The National Comprehensive Cancer Network (NCCN) recognizes ALK FISH as a specifically designed method for identifying ALK-rearranged lung cancers.1

RECOMMENDED USE2

ALK BY FISH

Clinical Utility

ALK rearrangements predict likelihood of response to ALK inhibitors such as crizotinib and ceritinib

ROS1 by FISH

Clinical Utility

ROS1 rearrangements predict likelihood of response to ALK inhibitors such as crizotinib and ceritinib

RET by FISH

Clinical Utility

RET rearrangements predict potential response to RET inhibitors such as cabozantinib

FGFR1 by FISH

Clinical Utility

FGFR1 amplification allows inclusion in FGFR clinical trials and are typically specific to Squamous Cell subtype in NSCLC

MET by FISH

Clinical Utility

MET amplification predicts potential response to duel ALK / MET inhibitors such as crizotinib, and potential acquired resistance to EGFR TKIs

EGFR by PCR

Clinical Utility

Predicts likelihood of response to EGFR TKIs: erlotinib, gefitinib, afatinib

KRAS by PCR

Clinical Utility

Predicts potential resistance to EGFR TKIs: erlotinib, gefitinib, afatinib

BRAF by PCR

Clinical Utility

BRAF mutations predict potential response to BRAF inhibitors such as vemurafenib and dasatinib

PD-L1 by IHC

Clinical Utility

PD-L1 expression predicts potential response to immunotherapy such as nivolumab and pembrolizumab

Read Studies About ALK FISH

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.

Read Studies About ROS1 FISH

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 (NGS)

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

mi-LUNG (microRNA)

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

Read Recent Studies About mi-Lung

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.

Read Studies About mi-LUNG Technology

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.

Read Studies About the Pathologist Interobserver Variability

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.

Read Studies About Variability In The
Performance Of Immunohistochemistry Markers

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.

*OncoGxLung is performed by and intrepreted by Admera Health


References

  1. National Comprehensive Cancer Network. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Non-Small Cell Lung Cancer (Version 1.2012). J Natl Compr Canc Net. 2011
  2. Genetically Informed Cancer Medicine - My Cancer Genome. 2015. http://www.mycancergenome.org. Accessed October 13, 2015.
  3. How is non-small cell lung cancer diagnosed?. 2015. American Cancer Society Website. http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-diagnosis. Updated March 4, 2015. Accessed September 23, 2015.
  4. 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.