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The firm is preparing to launch a clinical trial for the AdxBladder test in the US early in 2019 and use the results to apply for 510(k) clearance with the FDA.
Priorities for Q3 include the continued buildup of a commercial launch for the company's BarreGEN test. The firm has started a second clinical validation study for the test.
The firm has begun validating its porphyrin molecule marker test for use with flow cytometry at four sites and anticipates adding four, or more, to complete the validation.
With the new five-year funding, patients across Australia with rare or less common cancers will be able to access the program through a network of eight cancer centers.
Collaborators said that the test is accurate and reliable for the rapid detection of the most common gram-positive bacteria responsible for bloodstream infections.
Clinicians were surprised by a recent NEJM study that found that using procalcitonin assays did not reduce the use of antibiotics.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
Rna Diagnostics is hoping to make its RDA assay available as a laboratory-developed test for research use next year before offering it to clinicians in 2020.
A brief recap of Diagnostics news the week of Apr 20, 2018: Boston Scientific, Interpace, Human Longevity, CareDX, OpGen SeraCare Life Sciences, Omega Diagnostics, MDxHealth's SelectMDx.
BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.