In up to 50% of patients with suspected lung cancer it is not possible for clinicians and pathologists to confirm the diagnosis of malignant lung disease, even with both cytological and histological analysis of material taken at the time of first bronchoscopy.1,2 In these cases additional invasive diagnostic procedures are often required to confirm the presence of malignant disease, leading to a delay of diagnosis for the patient.
Epi proLung BL Reflex Assay
The Epi proLung BL Reflex Assay was developed to offer physicians additional information for the diagnostic workup of patients suspected of having lung cancer. The test is meant for use by physicians as an adjunct to existing clinical and pathological information to aid in the diagnosis of lung cancer. Because the test can be performed in conjuction with cytology on sample material routinely generated during bronchoscopy, the time to definitive diagnosis can be reduced and consequently the time-frame for start of treatment can be shortened. Recent studies have shown that presence of mSHOX2 (methylation of the gene SHOX2) in bronchial lavage samples is highly correlated with lung cancer. The addition of this molecular information to diagnostic cytology and other available clinical information may support clinicians and pathologists to diagnose lung cancer with certainty.
Figure 1: Lung cancer diagnostic work-up including measurement of SHOX2 gene methylation
The Epi proLung BL Reflex Assay consists of three kits:
- Epi proLung BL DNA Preparation Kit for cell lysis followed by bisulfite conversion and purification of DNA from Saccomanno-fixed bronchial lavage samples.
- Epi pro Lung BL real-time PCR Kit for detection of mSHOX2 in bisulfite-converted DNA. The test is a duplex- PCR, which amplifies methylated SHOX2 DNA as well as ACTB DNA (beta actin) for DNA quantification. A valid mSHOX2 test result is determined to be either positive or negative.
- Epi pro Lung BL Work Flow Control Kit contains positive and negative control samples to establish the successful execution of the entire work flow from cell lysis to DNA purification and bisulfite conversion, amplification and detection.
Figure 2: Workflow of the Epi pro Lung BL Reflex Assay
Performance data
Clinical Sensitivity and Specificity. The performance of the biomarker mSHOX2 has been established in a CE validation study with samples from 75 patients with lung cancer and 79 patients with other lung diseases (e. g. Pneumonia, Bronchitis, Influenza, COPD, Tuberculosis, Fungal Pneumonia, Sarcoidosis, Scleroderma). The mSHOX2 assay consistently identified 81% of the cancer cases at specificity of 95%.
Robustness. The Epi proLung BL Reflex Assay utilizes routinely generated, fixed sample material, which does not need further preparation. Handling and ease of use of the Epi pro Lung BL Reflex Assay was further optimized by combining as many test components as possible in the least number of needed reaction vessels. Moreover, major handling failures which could lead to false negative or false positive results were analyzed. It was verified that these failure modes were detected by the work flow controls or were minimized by the test design.
Reproducibility. Sample aliquots have been analyzed repeatedly with the Epi proLung BL Reflex Assay. This study was performed according to guidance from CLSI (Clinical and Laboratory Standards Institute) to demonstrate reproducibility of test results. Three different pools of bronchial lavage samples as well as mixtures of DNA with known relative amounts of methylation were analyzed. Three different reagent lots were used and the samples were analysed by three different operators on three different real-time PCR systems. The Epi proLung BL Reflex Assay was shown to deliver consistent results.
Order Information
Epi proLung BL Reflex Assay, for 24 determinations:
Order No. M6-01-001 Epi proLung BL DNA Preparation Kit
Order No. M6-01-002 Epi proLung real-time PCR Kit
Order No. M6-01-003 Epi proLung Work Flow Control Kit
Contact and Sales
Epigenomics AG
Kleine Praesidentenstr. 1
10178 Berlin
Germany
Phone: +49 30 24345-111
Fax: +49 30 24345-333
sales@products.epigenomics.com
www.epigenomics.com
CE-marked in accordance with the European IVD directive 98 / 79 / EC.
Applied Biosystems is a trademark of Life Technologies Inc.
Not for diagnostic use in the USA.
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References:
- K. Roth et al, Predictors of diagnostic yield in bronchoscopy: a retrospective cohort study comparing different combinations of sampling techniques, BMC Pulmonary Medicine 2008, 8:2
- G. Schreiber and D. McCrory, Performance Characteristics of Different Modalities for Diagnosis of Suspected Lung Cancer, Summary of Published Evidence, Chest. 2003;123 :115S –128S
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Download brochure "Epi proLung BL Reflex Assay"
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Safety data sheets
Safety data sheet Epi proLung Plasma DNA Preparation Kit
PDF file (583 kB)
Safety data sheet Epi proLung real-time PCR Kit
PDF file (80 kB)
Safety data sheet Epi proLung Work Flow Control Kit
PDF file (187 kB) |
