For Trey Martin, the president of Integrated DNA Technologies (IDT), the last few weeks have been anything but typical at the Coralville, Iowa company. Indeed, IDT finds itself in the center of the COVID-19 outbreak response. When the outbreak reached the United States in February, the CDC and FDA reached out to the well-known maker of DNA oligos to provide a key component of SARS-CoV-2 detection kit production—the primers that recognize the viral genome. Martin says that IDT gladly accepted.
“We’re honored to be a part of the effort to help in the outbreak” notes Martin. “We’ve always been able to scale up quickly. So, the fact that we could do that in the midst of a response, for public interest, has been very rewarding for our entire team.”
The CDC and FDA contacted IDT on Feb 25th to ask if they could support the testing protocol.
The second largest business unit at IDT is ISO 13485, which designates work done on medical devices and related services such as in vitro diagnostics. IDT makes several oligos used in diagnostics, just as the Foundation One cancer panel. In fact, they have been working in this space since 2007. “The idea that we would scale it up was very doable” notes Martin. “We have had that capability for a long time.”
On March 2nd, the FDA announced IDT as the first lot of primer probe kits used under the Emergency Use Authorization (EUA). As of March 9th, IDT shipped enough kits for 1 million tests. This week, Martin says, “we will manufacture sufficient kits to enable two and a half million reactions worth.” Next week—5 million. “We’ve been laser focused on scaling from nothing to 5 million in a few weeks” notes Martin.
IDT makes the primer probe kit, just one of four parts of the detection kit workflow, which is used alongside the RNA extraction kit, master mix, and thermocycler. Each kit, or 2019-nCoV CDC qPCR Probe Assay, contains 4 qPCR amplicons including an RPP30 control—all developed by the CDC. Available for order on the IDT website, the kit provides enough oligos to perform 500 samples and costs $125, making each reaction cost a quarter.
The kit contains primers and probes that have passed functional testing at the CDC and may be used with the CDC 2019-nCoV Real-Time RT-PCR diagnostic panel instructions for use under CDC’s Emergency Use Authorization (EUA). The primers currently target the N1, N2, and RP genes of the virus, but these are subject to change. For more information on the RT-PCR panel, please see the FDA website.
IDT took on the challenge “without question” and have shifted significant resources to make it happen. “We’re running 24/7”, Martin tells GEN, and will be able to produce sufficient kits to enable 5 million reactions a week for a while.
When asked to address the larger issue of test kit shortages, Martin tells GEN that “we only participate and control the part that we supply.” He adds that “everyone in the kit workflow will be asked and expected to scale in this way.”
Other companies, such as traditional in vitro diagnostic companies, are working on more complete solutions. LGC Biosearch Technologies has released a testing kit and the CRISPR-based companies Sherlock Biosciences and Mammoth Biosciences are working on CRISPR- based diagnostics. But, until other options become available, the Iowa company will keep churning out DNA oligos to play their part in quelling an epidemic.