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The Foundation for Innovative New Diagnostics is tracking commercial coronavirus diagnostics development project, with the goal of guiding procurement.
A number of manufacturers say that the shortage of swabs and transport media for facilitating SARS-CoV-2 testing that clinicians are facing will soon abate.
Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.
The firm will be validating the test with collaborators in China, and plans to pursue Emergency Use Authorization both in China and the US.
Directing lab-developed tests through the emergency use authorization process has brought to light reagent supply shortages and other hurdles.
SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.
The agency issued guidance noting that labs can test only the most challenging sample type and can use inactivated virus spiked into negative samples.
Labs can deploy the test kit omitting the pan-SARS component, and new kits that are specific only to SARS-CoV-2 are being manufactured.
As an expert in zoonotic viruses, Poon has published an assay for SARS-CoV-2 as well as a characterization of early infection.
Leadership aims to lower cost of goods and real estate footprint, while driving test utilization by targeting clinicians.
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.
According to the Guardian, UK virologists say in a letter to officials that their expertise has been pushed aside in COVID-19 response plans.
In Nature this week: tuatara genome sequence aids in understanding amniote evolution, and more.