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CE mark

Abbott said that the MDx platform offers a number of initial assays, including tests for HIV-1, HBV, and HCV, among others.

Omega said that the technical file supporting its CE mark will form the basis for seeking additional regulatory approvals.

The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.

The Vitros XT MicroSlide technology allows labs to run two tests that are commonly ordered together simultaneously from a single blood sample.

The test is designed to identify and differentiate between Zika, dengue, and chikungunya in serum samples, even in the presence of more than one target.

The firm said that the panel is expected to receive CE marking for commercial availability in Europe later this year.

The German firm said that researchers can now run its GynTect cervical cancer assay on Roche Diagnostics' Cobas z 480 analyzer.

The British molecular diagnostics firm recently completely a redesign of its point-of-care system, called Q-POC, and is planning to seek a CE-IVD mark for the device later this year.

The firm said that the test provides results of HBV status in 15 minutes with high analytical sensitivity, and that testing can be completed while the patient is present.

The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.

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