Close

FDA Grants Emergency Use Authorization for Eli Lilly, Sandia National Labs Coronavirus PCR Tests

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Related stories

China Unveils Innovative Drugs Policy to Boost Development

The National Health Commission and China's National Healthcare Security...

Ensuring optimal product integrity with pharmaceutical preservation strategies

Preserving the potency of pharmaceutical products is paramount in...

How Stem Cell Therapy Works for the Individual

Stem cell therapy has emerged as one of the...

Tjoapack Expands Injectable Packaging Capabilities Globally

Increased Capabilities in the United States Tjoapack is finishing up...

The US FDA granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Eli Lilly and Sandia National Laboratories.

The Lilly SARS-CoV-2 Assay is designed to detect the virus’ nucleocapsid gene in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate swabs, as well as nasal aspirates, nasal washes, and bronchoalveolar lavage fluid. Nucleic acid is purified using Qiagen’s QIAcube HT, and the test runs on Thermo Fisher Scientific’s Applied Biosystems QuantStudio 7 Flex, Applied Biosystems QuantStudio Dx, or Applied Biosystems QuantStudio 12K Flex RT-PCR systems.

The test may be performed only by Indianapolis-based Eli Lilly, according to the FDA.

Sandia’s SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic assay is designed to detect the SARS-CoV-2 nucleocapsid gene in upper respiratory and bronchoalveolar lavage specimens. RNA is isolated using Zymo Research’s Quick-RNA Viral Kit, and the test runs on Thermo Fisher’s Applied Biosystems 7500 or Applied Biosystems Quant Studio 5 systems or on Bio-Rad’s CFX Connect or CFX96 instruments. Use of the test is limited to Livermore, California-based Sandia, the FDA said.

Latest stories

Related stories

China Unveils Innovative Drugs Policy to Boost Development

The National Health Commission and China's National Healthcare Security...

Ensuring optimal product integrity with pharmaceutical preservation strategies

Preserving the potency of pharmaceutical products is paramount in...

How Stem Cell Therapy Works for the Individual

Stem cell therapy has emerged as one of the...

Tjoapack Expands Injectable Packaging Capabilities Globally

Increased Capabilities in the United States Tjoapack is finishing up...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back