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The agency said all tests for the virus must pass through its EUA process, but noted a test could be authorized under a single EUA for use in multiple labs.
The firm's AmplideX Fragile X Dx and Carrier Screen Kit is intended to help diagnose fragile X syndrome and assess parental risk of having a child with the syndrome.
DiaSorin got the nod for the Liaison Lyme Total Antibody Plus assay which uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi.
The devices are used for collection and stabilization of saliva samples for genetic testing, such as diagnostic testing or direct-to-consumer use.
The firm said that with this clearance it now provides a comprehensive menu of VZV and HSV tests from swab and cerebrospinal fluid specimens.
The company's newest products and planned updates reveal a focus on operational efficiency and increasing automation for core lab management.
The Cobas vivoDx MRSA test uses new bacteriophage technology based on bioluminescence to detect bacterial colonization in nasal swabs.
In the long term, the company is developing a plan to create more tests based on its technology, which digitizes blood samples and turns them into images.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
The companies gained FDA approval for the Liaison QuantiFeron-TB Plus Test, an automated workflow and assay for latent tuberculosis detection.