Helix
Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test
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.
Testing of Asymptomatic Patients Moves Into Spotlight During Coronavirus Pandemic
Some insiders emphasize the importance of doing rapid turnaround testing of asymptomatic people, while others contend lab tests ought to be the modality of choice.
Helix Coronavirus Test FDA EUA Reissued to Include Specimen Self-Collection
The reissued Emergency Use Authorization from the US Food and Drug Administration also permits the test's use in asymptomatic individuals, the firm said.
Helix Gets FDA Emergency Use Authorization for NGS-Based COVID-19 Test
The in vitro diagnostic test runs on the Illumina NovaSeq 6000 instrument and will be performed at Helix's San Diego CLIA-certified laboratory.
Illumina Sees Expanding Sequencing Market in COVID-19 Response, Despite Short-Term Woes
The sequencing firm said infectious disease research, diagnostics, screening, and surveillance could all increase demand for its NGS products.