Integrated DNA Technologies (IDT), a leading comprehensive genomics solutions provider, today announced its success in large-scale manufacturing of a key component used to enable testing of millions of Americans for COVID-19.
IDT’s key component is a primer and probe kit, which assists in DNA analysis of patient samples.
As of March 9, IDT had shipped and the Centers for Disease Control and Prevention (CDC) has qualified primer and probe kits sufficient to enable over 1 million tests to be conducted pursuant to the CDC Emergency Use Authorization (EUA) testing protocol. IDT manufactured sufficient primer and probe kits to enable an additional 2.5 million tests during the week of March 9, and expects to manufacture 5 million tests per week starting March 16, and thereafter.
“We are honored to be the first company in the nation to have our primer and probe kits approved by the CDC for use as a key component of the CDC EUA testing protocol for the diagnosis and detection of COVID-19,” said IDT President Trey Martin.
“We continue to scale production to meet demand and we are in close communication with the CDC and U.S. Food and Drug Administration (FDA). IDT will also continue to supply its key component to laboratories, which may assist them in the development of a COVID-19 vaccine,” Martin added.
IDT’s recent history includes providing products to diagnostic test manufacturers developing test for H1N1, Ebola virus, and Zika virus.
The primer and probe kits are manufactured in IDT’s Coralville, Iowa headquarters under ISO 13485:2016 conditions in a suite of cleanrooms designed to prevent synthetic template contamination.
More information about IDT’s efforts to fight against COVID-19 can be found here.
IDT is an operating company within Danaher Corporation’s (NYSE: DHR) Life Sciences platform. For more information, please visit www.idtdna.com.