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Almac

The lack of a ready infrastructure has some manufacturers spooked about a regulatory bottleneck as the date for compliance draws closer.

Almac said that the assay will be used in a clinical study of repotrectinib (TPX-0005), an investigational, next-generation tyrosine kinase inhibitor.

The test relies on a signature that Almac developed for stratifying breast cancer patients, but which, as the researchers showed, can be used in other cancers as well.

The next-generation sequencing assay is intended for use in identifying patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors.

Almac is developing the assay to enroll patients for clinical trials used to develop repotrectinib, an investigational tyrosine kinase inhibitor.

The test is intended to identify patients with ROS1, NTRK, and ALK gene fusions for treatment with TP's investigational drug repotrectinib.

OraSure Technologies reported a 31 percent year-over-year increase in its third quarter revenues, including a 186 percent rise in hepatitis C revenues. For the three months ended Sept. 30, total revenues grew to $42.3 million from $32.3 million in Q3 2016. It beat the consensus Wall Street estimate of $40.8 million.

The company plans to outlicense the assay, developed using a custom Affymetrix microarray, to an interested partner.

The collaboration will streamline patient sample analysis to determine whether they should be included in clinical trials for molecularly targeted treatment.