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FDA submission

Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.

The firm's tool uses a balloon catheter to collect cells from a targeted region of the esophagus without the need for endoscopy

Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.

The firm beat analysts' revenue expectations for the quarter while its net loss was in line with predictions.

The company received guidance from the FDA and will continue to provide additional data for a new submission to achieve 510(k) clearance for its dry-eye test.

The firm has completed submissions for all three of its ePlex panels for diagnosis and management of bloodstream infections that can lead to sepsis.

The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of  the test as an LDT.

The test, which uses lateral flow immunochromatographic technology, demonstrated high accuracy in a recent study and is being planned for a submission to the FDA.


The firm is also developing a second system designed to run clinical chemistry tests for low- and medium-volume labs.

The Elecsys beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF assays are used to measure peptide biomarkers in the CSF of patients with cognitive impairment.

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