FDA expanding U.S. COVID-19 test capacity, industry ramping up to meet demand
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The U.S. FDA Monday night announced new policies and Emergency Use Authorizations to expand COVID-19 test capacity.
Diagnostics companies are also stepping up to meet demand. Qiagen is increasing production of RNA extraction kits, and more companies are seeking and obtaining authorization to offer tests.
Expanding on a decision made Feb. 29 to allow the New York State Department of Health to take responsibility for COVID-19 test regulation, FDA is allowing all states to regulate COVID-19 testing. Every state now has the power to set up a system to allow labs to seek authorization directly from the state government, instead of from FDA.
Labs that obtain state approval for a COVID-19 test will not have to obtain an Emergency Use Authorization (EUA) from FDA.
In addition, FDA said it “does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances.” The agency is allowing distribution and use of tests while manufacturers prepare EUA requests if the manufacturer posts performance data on its website. The agency is giving companies 15 business days to prepare EUA submissions.
To speed the development and deployment of serological tests to measure antibodies or proteins indicating that an individual has been exposed to the virus that causes COVID-19, FDA is allowing such tests to be sold without receiving prior clearance.
Antibody tests are valuable tools for tracking the spread and evolution of COVID-19 because they can identify individuals who have been exposed to the virus who didn’t develop symptoms or who have recovered, and therefore wouldn’t be identified by diagnostic tests.
The agency stated that “serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis.” Therefore, FDA said it “does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests.” The agency said warnings should indicate that the test has not been reviewed by FDA and results from antibody testing should not be used “as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.”
Industry ramping up
Qiagen N.V. (NYSE:QGEN; Xetra:QIA) announced that it will “dramatically ramp up global production capacity of RNA extraction kits that are used as part of workflows around the world to detect nucleic acid from SARS-CoV-2, the novel coronavirus that causes COVID-19.”
Qiagen said it usually produces sufficient RNA nucleic extraction reagents for 1.5 million patient tests per month. It plans to expand manufacturing to support more than 6.5 million tests per month by the end of April and over 10 million per month by the end of June.
The company also said it expects to receive a CE-IVD mark in the coming days for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic (IVD) for the detection of SARS-CoV-2.
Qiagen is also discussing an EUA for the test with FDA. The company has received $598,000 from the Biomedical Advanced Research and Development Authority (BARDA) to support development of the platform.
FDA Monday night granted EUAs to Hologic Inc. (NASDAQ:HOLX) for its Panther Fusion SARS-COV-2 Assay and to Laboratory Corp. of America (LabCorp) for its COVID-19 RT-PCR test.
The Hologic test, developed with BARDA funding, can produce results with three hours and is capable of processing up to 1,000 tests in 24 hours.
Becton Dickinson and Co. (NYSE:BDX) and molecular diagnostic developer BioGX Inc. have submitted an EUA to FDA for new rapid COVID-19 tests.
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