NEW YORK – Integrated DNA Technologies, a Danaher company, has been authorized by the US Food and Drug Administration to provide reagents for diagnostic testing for the SARS-CoV-2 virus. The authorization has been granted under the Centers for Disease Control and Prevention's existing emergency use authorization.
High-complexity labs in the US became eligible under new FDA guidance issued Saturday to create their own diagnostic test kits for the coronavirus disease COVID-19 caused by the SARS-CoV-2 virus. However, the new guidance states that labs must apply for EUA within 15 days of beginning testing. Public health labs can also still obtain test kits from the CDC.
In a webinar with labs on Monday, Timothy Stenzel, director of the office of in vitro diagnostics and radiological health at the FDA, noted that labs can also choose to purchase test kits from IDT, and that there is one lot number of test kits so far that has been validated and authorized.
Specifically, Stenzel said during the webinar, "Under the CDC's EUA, there is another covered test, and that is the IDT 2019-novel coronavirus kit. ... The CDC is doing lot qualification testing, and the lot that has already passed [quality control] at the CDC is lot number #0000500383," Stenzel said.
Furthermore, he noted that labs with an authorized kit lot can verify the test as they normally would any reagents in the lab before the first use, and then begin clinical testing. They will not subsequently be required to apply for EUA.
"If you are using [a kit] that is already authorized by the FDA - in this case IDT has authorization under the CDC EUA ... that test has already been developed and qualified per lot, and all that you need to do if you get one of those qualified lots from IDT, or any of the follow-on manufacturers having EUA, [is] follow your normal laboratory procedures when you receive a new kit before you being testing. There is no notification of the FDA required."
Additional IDT lots are undergoing qualification by the CDC, and that information will be made known publicly as soon as possible, Stenzel also said.
Any high-complexity CLIA-certified lab can purchase the kits, and Stenzel said that this includes commercial labs.
"There may be traditional IVD manufacturers who would also like to get a EUA authorized kit through any of the manufacturers who have an EUA authorization, such as IDT has under the CDC [EUA] – we understand that having such a kit may be helpful in your test development process, and I don't want to exclude those entities from being able to purchase the kits," Stenzel said.
Finally, the CDC and the Biomedical Advanced Research and Development Authority are working with "multiple IVD manufacturers and laboratories to enable additional EUA authorizations as soon as possible," Stenzel said.