The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
Streck said its collection tube maintains native cell-free DNA populations and provides sample integrity by reducing the release of cellular genomic DNA.
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 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.
The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.