Test developed by DxS will be used in Phase III trials to select patients who are most likely to respond to treatment.

DxS Diagnostics and Boehringer Ingelheim signed an agreement to provide a company diagnostic for the latter’s non-small-cell lung cancer (NSCLC) drug. The aim is to develop the test such that it is suitable for global commercialization with the Boehringer Ingelheim’s tyrosine kinase inhibitor, BIBW 2992, which is in late-stage development.

The test is based on DxS’ CE-marked TheraScreen EGFR29 kit and has been manufactured at DxS’ facilities in the U.K. It will be incorporated into Boehringer Ingelheim’s global, multicentre Phase III clinical trial later this summer. The diagnostic will be used to select NSCLC patients that carry certain mutations of the epidermal growth factor receptor (EGFR). 

BIBW 2992 acts by irreversibly blocking the EGFR /HER2 receptors. Clinical data published to date, according to the firms, suggests that the compound offers a marked increase in efficacy in comparison to standard treatments for lung cancer patients carrying mutations in the EGFR gene.

TheraScreen is already commercially available as a stand-alone companion diagnostic in Europe, South Africa, and Saudi Arabia but is not yet cleared in other major markets including the U.S.

“The requirements of different regulatory authorities vary in terms of whether a companion diagnostic is approved for use as a stand-alone product or only in conjunction with specific drug therapies,” comments Stephen Little, DxS CEO. “We would hope that our joint development of an EGFR mutation companion diagnostic for BI’s BIBW 2992 will see the test progress through regulatory clearance in all major markets including North America.”

DxS’ TheraScreen EGFR29 is a real-time PCR assay based on the company’s Scorpions® technology and mutation-specific ARMS® primers. The test detects 29 of the most common somatic mutations in the EGFR gene. The TheraScreen EGFR29 kit is being distributed by Roche, which also distributes DxS’ TheraScreen K-RAS mutation test. The K-RAS kit is available in Europe to support targeted therapies against colorectal cancer.

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