Helix
Qiagen, Helix Partner for Hereditary Disease CDx Development
The partnership will leverage Helix's whole-exome sequencing platform and incorporate Qiagen's biopharma relationships, NGS capabilities, and global regulatory expertise.
Helix Obtains FDA Emergency Use Authorization for SARS-CoV-2 Molecular Test With Self-Collection
This test is authorized to detect nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected using the Helix COVID-19 Self-Collection Kit.
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.