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The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
Streck said its collection tube maintains native cell-free DNA populations and provides sample integrity by reducing the release of cellular genomic DNA.
The sequencing-based test for minimal residual disease can be use with blood and bone marrow samples in patients with chronic lymphocytic leukemia.
The test measures IgE antibodies to alpha-gal in blood. An allergy to alpha-gal can cause patients to have a severe and potentially life-threatening reaction.
The expanded test can be used for genotype risk-based patient monitoring to prevent over-treatment, BD has said.
Paige said that the regulatory clearance paves the way for the in vitro diagnostic use of FullFocus with additional IVD whole slide imaging scanners.
Quest expects to deploy the pooled sample technique at its laboratories in Chantilly, Virginia and Marlborough, Massachusetts by the end of next week with additional laboratories to follow.
The firm said that together with other clinical findings, the test can help manage patients prescribed clozapine for treatment-resistant schizophrenia.
Horiba received clearance for its Yumizen C1200 CRP reagent used to measure C-reactive protein for evaluation of infections, tissue injury, and inflammatory disorders.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.