FDA submission

The company said it expects to launch the Verigene II system with respiratory and gastrointestinal assays in the middle of this year.

ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.

The agency compiled the evolving list by drawing on information from drug labeling and the published literature and is asking stakeholders to provide feedback.

AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.

The new test increases the multiplexing of the sepsis panel from 26 targets to 43 targets, including seven additional resistance genes.

The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.

The company's platform and assay use fluorescent lateral flow technology to detect Helicobacter pylori antigens in human stool samples.

The final guidance seeks to streamline the process, which has typically required separate submission processes for the drug and the device.

The firm said it anticipates launching the platform in Europe next year and completing its first round of external financing in the first quarter of 2020.