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Becton Dickinson

Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.

The system is used to automate sample preparation steps for assays that are run on BD's FACSLyric clinical flow cytometer.

The company reported growth across all three of its business segments and reaffirmed its full-year guidance.

Illumina said this week that the US Food and Drug Administration has granted breakthrough device designation for its pan-cancer assay, which is currently in development.

The firm also reaffirmed its previous guidance of 10 percent growth for fiscal 2019.

GenMark got clearance for an assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections, and it received clearance for a bacterial assay.

Among the updates provided Wednesday, Quidel's CEO noted the firm's growing presence in point-of-care markets, while PerkinElmer discussed plans for its Vanadis test.


The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.

The company developed the test with Boston University researchers as part of an effort to push its surface-enhanced Raman scattering tech for POC applications.

The FDA cleared BD's test for detecting carbapenemase-producing organisms, which can be used by hospitals to contain the spread of antimicrobial resistance.

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