Recent studies into non-small cell lung cancer have shown that some patients carry somatic mutations in the epidermal growth factor receptor (EGFR) gene. These mutations correlate with responsiveness to tyrosine kinase inhibitors such as gefitinib and erlotinib, with some mutations having a sensitizing effect and others being linked to resistance.

The TheraScreen: EGFR29 kit enables the detection of the following mutations against a background of wild type genomic DNA in a real time PCR Assay based on Scorpions® technology and mutation specific ARMS® primers. The test is highly selective and sensitive, detecting 29 of the most common somatic mutations in the EGFR gene. The kit maximises patient selection of likely responders by identifying mutation positive patients. The kit detects mutations not visible by sequencing.

The TheraScreen: EGFR29 Kit is not intended for use to screen for or diagnose cancer.  Its use is intended as an adjunct to other prognostic factors currently used to select suitable patients for treatment with tyrosine kinase inhibitor therapies, based on the patient’s mutation status. The patient’s mutation status will be considered by a Clinician, alongside other disease factors to make a therapy decision. No treatment decision for cancer patients should be based on EGFR gene mutation status alone.

Intended Use
TheraScreen is to be used to aid doctors in selecting lung cancer patients suitable for treatment with tyrosine kinase inhibitor therapies.

Technological Principles
DxS has combined ARMS® (allele specific PCR) with the Scorpions® real-time PCR technology to develop sensitive and robust tests for EGFR mutations.

EGFR Mutations
The DxS kit detects the following mutations against a background of wild type genomic DNA in a real time PCR assay:

• 19 deletions in exon 19
• T790M
• L858R
• L861Q
• G719X (detects the presence of G719S, G719A or G719C but does not distinguish between them)
• S7681
• 3 insertions in exon 20 (detects the presence of any of 3 insertions, but does not distinguish between them)

Protocol
After DNA extraction, real time PCR assays are performed to detect the target molecule.  By comparing control and mutant sample reactions users can detect and estimate low levels of mutation. No further sample processing is necessary and the time to result is <3 hours.

Kit Attributes:

• Maximises patient selection of likely responders by identifying mutation positive patients, frequently missed by other methods
• Depending on the total amount of DNA present, the kit can detect 1% of mutant in a background of wild type genomic DNA. The assays have a limit of detection of 10 copies or below. These sensitivity and detection levels are superior to commonly used methods such as sequencing.
• Simple and easy to follow protocol, with same day results.
• Sample types include DNA from plasma or fresh, frozen or paraffin embedded tissue (PET).
• Kit combines two technologies, ARMS® (allele specific PCR) and Scorpions® to detect mutations in real-time PCR reactions.
• Qualitative assessment of patient mutation status; accurately detects mutations, insertions and deletions.
• Compatible with most real-time PCR instruments.
  

Regulatory Registrations
DxS’ TheraScreen: EGFR kit has been CE-marked in accordance with the European IVD Directive 98/79/EC. The product is available for sale in the following countries:

Belgium
Denmark
Finland
France
Germany
Ireland
Italy
Luxembourg
Netherlands
Norway
Portugal
Spain
Sweden
Switzerland
UK

Instructions For Use
To download the TheraScreen: EGFR29 Instructions For Use booklet, please register your details in the fields below and then you will be able to select the preferred language for the Instructions For Use.
English
German
French
Spanish
Italian
Danish
Dutch
Portugese
Swedish
Norwegian

How to Order
Please quote the product code and kit size when you order:
Product Code: EG-21 20 reaction kit
Product Code: EG-22 80 reaction kit

To place an order please email sales@dxsgenotyping.com or call +44 161 606 7201

Technical Support / Frequently Asked Questions:
Click here for Knowledge Base & FAQ's Registration

References:

• 1. Guillermo Paez J, Pasi A.Jänne, Jeffrey C.Lee et al. EGFR Mutations in Lung Cancer: Correlation with Clinical Response to Gefitinib Therapy. Sciencexpress , 1-10. 4 A.D.

• Lynch TJ, Bell DW, Sordella R et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 2129-2139.

• Raffaella Sordella, Daphne W.Bell, Daniel A.Haber, Jeffrey Settleman. Gefitinib-Sensitizing EGFR Mutations in Lung Cancer Activate Anti-Apoptotic Pathways. Science 305, 1163-1167.

• Kimura H, Kasahara K, Kawaishi M et al. Detection of Epidermal Growth Factor Receptor Mutations in Serum as a Predictor of the Response to Gefitinib in Patients with Non Small-Cell Lung Cancer. Clin Cancer Res 2006;12(13) July 2006.

• Newton CR, Graham A, Heptinstall LE et al. Analysis of any point mutation in DNA. The amplification refractory mutation system (ARMS). Nucleic Acids Res. 1989; 17: 2503-2516.

• Whitcombe D, Theaker J, Guy SP, Brown T, Little S. Detection of PCR products using self-probing amplicons and fluorescence. Nat.Biotechnol. 1999; 17: 804-807.