This article was originally published March 16, 2020. The CBJ is revisiting some of the biggest stories from the last 20 years, in celebration of our anniversary.
Coralville-based Integrated DNA Technologies (IDT) has stepped into the void as federal health officials face criticism they’ve been slow to develop and roll out widespread coronavirus testing nationwide.
The company, which began shipping primer and probe kits to the Centers for Disease Control last month after the Food and Drug Administration amended its rules on who can produce them, has already delivered hundreds of thousands of kits and is ramping up to deliver even more.
“IDT is proud to play an important role in the fight against 2019-nCoV,” said spokeswoman Lee Betancourt of APCO Worldwide, which is handling public affairs for IDT. “We are the first company in the nation to have our primer and probe kits approved by [the CDC]. Our primer and probe kits are a key component of the CDC testing protocol for the diagnosis and detection of COVID-19, for which the CDC obtained Emergency Use Authorization (EUA).”
Ms. Betancourt said IDT had shipped material sufficient to enable more than 1 million tests under CDC EUA testing protocol as of March 9. The company was on track to manufacture enough kits to enable 2.5 million more tests last week and 5 million tests this week and every week thereafter.
“IDT will also continue to supply primer and probe kits to research laboratories to assist them in the development of a COVID-19 vaccine,” Ms. Betancourt said.
In remarks on March 6, FDA Commissioner Dr. Stephen Hahn said that while the CDC is typically the first developer of diagnostics in emergencies like the coronavirus outbreak, early manufacturing problems – since resolved – led the agency to reach out to third-party manufacturers like IDT to quickly produce tests for distribution. He stressed that each test made by private manufacturers goes through quality control testing by the CDC.
Dr. Hahn said the first batch of IDT-assisted tests were shipped to California and Washington based on confirmed clusters in those states, with another 400,000 set to ship elsewhere in the first week of March.
Health and Human Services Secretary Alex Azar, who admitted public health labs only had the ability to test 15,000 people at the beginning of the U.S. outbreak, said that thanks to IDT’s test materials, enough kits would be on hand to test between 1.5-1.7 million people by the end of last week.
IDT develops, manufactures and markets nucleic acid products for the life sciences industry in the areas of academic and commercial research, agriculture, medical diagnostics and pharmaceutical development. According to the company’s website, “manufacturers of synthetic DNA, like IDT, often find themselves involved very early in the process of addressing emerging diseases,” adding that in recent years it has assisted in the development of field diagnostic tests for Ebola virus.
As early as late January, IDT was accepting pre-orders from the global public health and research communities for qPCR primers and probes designed to detect the novel coronavirus, 2019-nCoV.
“Fighting emergent pathogens is among the most important efforts that researchers undertake,” IDT President Trey Martin said at the time. “We’re thankful for all the researchers willing to suit up for these battles, and if we can make their progress faster or easier, we’re going to be there to help them.”
IDT has its manufacturing headquarters in Coralville, with additional manufacturing sites in San Diego, California; Leuven, Belgium; and Singapore.
