Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.
The announcement follows EUAs for SARS-CoV-2 tests developed by the CDC, Roche Holdings AG, the New York State Department of Health, Thermo Fisher Scientific Inc., Hologic Inc., Laboratory Corp. of America, Quidel Corp. and Quest Diagnostics Inc. Other companies have submitted COVID-19 tests to the FDA, including Becton Dickinson & Co. and Genmark Diagnostics Inc., and still are working to make testing available.
Kits delivered in 18 states
Abbott said it already has delivered its Realtime SARS-CoV-2 tests to hospitals and teaching hospital laboratories in 18 states, including California, Illinois, Massachusetts, New York and Washington. The company is ramping up production at its U.S. manufacturing site and expects to be churning out 1 million tests per week within the next two weeks.
“A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to address it,” said Miles White, Abbott’s CEO. “I’m proud of the Abbott team and what they’ve accomplished in such a short period of time, and I want to thank the administration and the FDA for their partnership in making this happen.”
The tests are performed on Abbott’s m2000 Realtime system, a polymerase chain reaction (PCR)-based molecular diagnostics platform featuring a broad menu of infectious disease assays. The systems can process up to 470 tests in a 24-hour period, which could be critical as demand for COVID-19 testing increases.
More than 175 m2000 systems already are deployed in U.S. hospitals and reference labs, and Abbott said it is working with government agencies and health care systems to place more units.
Qiagen launches syndromic panel for SARS-CoV-2 detection in EU
Meanwhile, Qiagen NV, of Venlo, Netherlands, reported the CE-IVD marking and launch of the first syndromic testing solution in Europe for the detection SARS-CoV-2.
The Qiastat-Dx Respiratory SARS-CoV-2 Panel test is capable of differentiating the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients with similar symptoms, such as fever, sneezing and coughing. That could be key in improving early diagnosis of COVID-19 cases and ensuring people who are sick or contagious are quarantined and treated.
A multiplexed, nucleic acid test, the Qiastat-Dx respiratory panel analyzes samples such as nose and throat swabs and includes assays targeting two genes used to identify SARS-CoV-2. It also detects four other coronaviruses, adenovirus, human metapneumovirus A+B, influenzas A, A H1, A H3, A H1N1/pdm09, influenza B, several types of parainfluenza virus, rhinovirus/enterovirus, respiratory syncytial virus A+B, bocavirus, Bordetella pertussis, Legionella pneumophila and Mycoplasma pneumoniae.
Evaluation of the test kits got underway last month in various European markets, and Qiagen has boosted production dramatically to meet demand as the virus continues to spread. The panel runs on the company’s Qiastat-Dx Analyzer, an automated molecular analysis system. To perform the test, technicians put a sample in a single-use Qiastat-Dx cartridge and place that in the analyzer. The instrument includes clinical chemistries for DNA and RNA sample processing and analysis. Turnaround time is about an hour.
“Our Qiagen teams have responded rapidly to the spread of the COVID-19 disease, implementing 24/7 production of test components, adding staff and investing in expanded production capacity,” said Thierry Bernard, interim CEO and senior vice president of Qiagen’s molecular diagnostics business. “In addition to Qiastat-Dx, we are supplying RNA extraction kits under the Qiaamp and Ez1 brands that have been recommended in current testing guidelines worldwide, as well as numerous components and instruments for use in fighting this public health crisis.”
The company did not respond to a query about current and future production levels for the Qiastat-Dx respiratory panel.
Other companies with emergency use authorization for SARS-CoV-2 tests are also ramping up production. Thermo Fisher told BioWorld this week that it had 1.5 million tests ready to ship under its EUA as of March 16, and expects to increase weekly output to 2 million in coming weeks. The goal is to reach up to 5 million tests weekly in April. The tests are optimized for the company’s Applied Biosystems 7500 PCR analyzer.
And Quest Diagnostics said it anticipates increasing testing capacity for its SARS-CoV-2 rRT-PCR test to 20,000 per day, with weekly volume reaching 280,000 tests by early April, provided that swabs, reagents and other supplies continue to be available.