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New EGFR diagnostic kit to be made available globally


DxS, a personalised medicine company, and Boehringer Ingelheim have entered into an agreement to provide a companion diagnostic test kit for the latter’s compound BIBW 2992 (Tovok™) to identify mutations of the EGFR (epidermal growth factor receptor) in patients with non-small-cell lung cancer.

Clinical data published to date suggest that BIBW 2992 offers a marked increase in efficacy in comparison with standard treatments, for lung cancer patients carrying mutations in the EGFR gene. Under the terms of the agreement, DxS and Boehringer Ingelheim will work jointly to make a suitable companion diagnostic test kit globally available.

BIBW 2992 is a novel tyrosine kinase inhibitor that acts by irreversibly blocking the EGFR/HER2 receptors, which are promoters of tumour growth. As with other tyrosine kinase inhibitor therapies, patients with mutations in the EGFR gene will be more likely to respond to a medication that targets these receptors, thereby allowing doctors to prescribe the most effective and individual treatment.

Furthermore, BIBW 2992 has demonstrated preclinical activity against erlotinib- and gefitinib-resistant mutations. With this approach, Boehringer Ingelheim is among the few companies advancing molecules in their pipeline within the area of personalised medicine.

The DxS EGFR companion diagnostic is a real-time PCR assay designed to detect the most common mutations in the EGFR gene. The diagnostic has been developed and manufactured at DxS’ head office in Manchester, UK. and will be available later in the summer for Boehringer Ingelheim’s global, multicentre phase III clinical trial for BIBW 2992.

Commenting on this announcement, Dr Stephen Little, CEO of DxS, said: “This is another great endorsement of our companion diagnostic assays for predicting patient response to targeted therapies. It is an exciting step forward for personalised medicine, and DxS is pleased to be at the forefront of this revolution in cancer treatment.”

“As this year’s theme at ASCO highlights, it is very likely that personalised medicine will play an important role in selecting the most effective treatment for patients with cancer. We are convinced that the collaboration agreement with DxS can expedite our efforts in the field of personalised medicine. And both companies are excited to investigate how molecular diagnostics can support patient selection and help to maximise treatment outcome with our medication,” said Dr Manfred Haehl, corporate senior vice president medicine of Boehringer Ingelheim.


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