Streck said its collection tube maintains native cell-free DNA populations and provides sample integrity by reducing the release of cellular genomic DNA.
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.
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.