You may find more results for this query on our sister sites: 360Dx and Precision Oncology News.
With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.
The firm's Continuum system is fully automated and performs the entire digital PCR workflow in a single instrument.
The partners received Emergency Use Authorization last week for a test that uses oral fluids, and the lab has capacity to test up to 10,000 samples per day.
The agency plans to work with a number of partners to develop codes that will describe tests and results to standardize data collection.
MBS has developed a compact endpoint PCR system which can test more than 22,000 patient samples per day by performing eight-minute thermal cycling.
The Atila iAMP test was granted Emergency Use Authorization earlier this week and is being evaluated in multiple US labs.
The firm had been in stealth mode, but hopes to now attract partners to further commercialize its system for decentralized testing.
Bringing testing closer to patients could be helpful, provided enough tests and instruments can be manufactured and distributed.
Droplet digital PCR tests for SARS-CoV-2 can potentially detect the very low viral loads seen in asymptomatic and convalescent cases.
The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.
Public health experts call for a transparent COVID-19 vaccine approval process in a letter; the Food and Drug Administration commissioner assures science-based approval.
The Verge reports that new gene-naming guidelines aim in part to avoid Excel-related name change confusion.
In Nature this week: tuatara genome sequence aids in understanding amniote evolution, and more.
According to the Guardian, UK virologists say in a letter to officials that their expertise has been pushed aside in COVID-19 response plans.