Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

New York State’s Wadsworth Lab And NYC’s Public-Health Lab Win Go-Ahead For COVID-19 Testing

Executive Summary

The US FDA on 29 February approved New York State’s and New York City’s combined Emergency Use Authorization request to conduct coronavirus testing at the state’s Wadsworth Center laboratory in Albany, and its NYC public-health department-based lab. Both sites are CLIA-certified to proceed using COVID-19 laboratory-developed tests, the FDA’s Tim Stenzel said during a 2 March webinar on virus testing.

You may also be interested in...



FDA Issues Revised Reauthorization Of CDC COVID-19 Test, OK’s Change To New York Test

The US agency issued a revised version of an Emergency Use Authorization (EUA) to the Centers for Disease Control and Prevention for the CDC’s COVID-19 test on 15 March, and approved an amendment to New York State’s EUA for its assay on the same day.

LabCorp Launches COVID-19 Testing, Quest Diagnostics Will Provide Testing Starting 9 March In US

LabCorp and Quest announced they will offer testing to detect COVID-19 to address the public health crisis.

COVID-19: FDA Eases Approval Policy By Allowing LDT Use Under ‘Immediately In Effect’ Guidance

The US FDA on 29 February issued a new guidance giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under Emergency Use Authorization. The agency issued the guidance quickly, taking the unusual step of forgoing a public comment period.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT126341

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel