The U.S. FDA posted an updated FAQ for diagnostic testing for SARS-CoV-2, stating among other things that the CDC test authorized under the FDA’s emergency use authorization (EUA) can be performed on several instruments. Among these are the Applied Biosystems 7500 Dx PCR system and Quantstudio Dx, also by Applied Biosystems. The Qiagen Rotor-Gene Q system is also authorized to run the test. Among the extraction platforms authorized under the EUA are two Roche and one Qiagen units, and the update provides instructions on fabricating positive controls. The agency clarified that developers need not fully validate their EUA tests prior to communicating with the agency, adding that labs qualified under CLIA to perform high-complexity testing do not need an EUA authorization if they purchase their reagent kits from Integrated DNA Technologies and follow the CDC protocol.
The Office of the U.S. Trade Representative has lifted tariffs for a number of items imported from China as a response to the COVID-19 crisis per a request from manufacturers and the Advanced Medical Technology Association (Advamed). Advamed President and CEO Scott Whitaker penned a Jan. 31 letter to U.S. Trade Representative Robert Lighthizer requesting that the administration lift Section 301 tariffs on medical products that are “critical to helping to contain the coronavirus,” adding that some of the tariffs have been placed on medical products that are “troubling from a public health perspective.” Whitaker said Advamed was in touch with officials in Beijing regarding tariffs slapped on U.S. products exported to China as well. The list of tariff exemption requests is searchable and includes a request for lifting of tariffs on personal protective equipment filed on behalf of Cardinal Health, of Dublin, Ohio, by Crowell & Moring LLP, of Washington, as well as Advamed (see exclusion request no. USTR-2019-0017-39058). Whitaker said in a March 9 statement, “we thank the administration for lifting tariffs from some crucial medical equipment” coming from China, particularly given the COVID-19 outbreak. Whitaker said the change in policy will help lower the cost of importing various articles essential to the effort to stanch the crisis, such as N95 masks, examination gloves and surgical drapes and gowns. He said Advamed will continue working with the administration to expand the list of items exempted from the tariffs.
The American Medical Association (AMA) will hold a March 13 teleconference meeting of the CPT editorial committee to consider a novel CPT code for coronavirus testing, which will take place at 5:00 p.m., Central time. Chicago-based AMA said in a March 10 statement that the editorial panel will employ an expedited process for creation of a test description and an effective date for the code, adding that the AMA has been in touch with the U.S. CDC to ensure the new code will meet the need for accurate reporting of a diagnostic test for the SARS-CoV-2 virus.