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Almac Diagnostic Services to Build Pan-Cancer NGS Companion Test for TP Therapeutics

NEW YORK (GenomeWeb) – Almac Diagnostic Services and precision oncology pharma TP Therapeutics said today that are collaborating to develop and commercialize a next-generation sequencing companion diagnostic for TP's repotrectinib, an investigational tyrosine kinase inhibitor targeting ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors.

Under the agreement, Almac will develop the test based on the ArcherDx Anchored Multiplex PCR chemistry, with the intent of submitting it for regulatory approval in the US. Almac's CLIA-accredited laboratory in Durham also intends to make the assay available to help physicians to select appropriate patients for treatment with repotrectinib.

Various existing NGS assays also include ROS1, NTRK1-3 and ALK fusions, including laboratory-developed tests, as well as panels recently approved by the US Food and Drug Administration, like Foundation Medicine's FoundationOne CDx.

Almac Managing Director Paul Harkin said in a statement that the company believes that its track record developing and validating assays "under design control and according to regulatory requirements," puts it in a strong position to achieve the goals of the collaboration.

Financial terms of the agreement were not disclosed.