Companies Offering COVID-19 Testing Kits
ProcurementIQ provides a list of vendors offering COVID-19 testing kits
NC-based LabCorp made its tests available March 5, 2020. The company has ramped up its capacity through increased hiring and as of March 20, they have been able to complete 20,000 tests per day. The turnaround time for tests is 3-4 days.
NJ-based Quest Diagnostics received an EUA from the FDA for its SARS-CoV-2 PCR test on March 17, 2020. Between its own tests, as well as others that have been authorized, the company is performing 25,000 COVID-19 tests per day and is reaching 30,000 tests per day by the end of the first week of April.
Roche Diagnostics, a Swiss company with US headquarters in Indiana, is rapidly producing test kits. As of March 16, Roche announced that they have begun to ship the initial 400,000 cobas SARS-CoV-2 Test of COVID-19 kits to a network of hospital and reference laboratories across the United States. This is after Roche received approval under the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Roche then plans to ship 400,000 tests per week to testing sites across the nation. The test kits will run on Roche’s fully automated cobas 6800 and cobas 8800 systems, which can process up to 384 results and 960 results, respectively, in an 8-hour shift.
MA-based Thermo Fisher Scientific has received EUA from the FDA for its COVID-19 test called Applied Biosystems TaqPath COVID-19 Combo Kit to be used in conjunction with their recently approved and distributed Applied Biosystems7500 Fast Dx Real-time PCR. The test kit allows for up to 94 specimen evaluations in 3 hours. In April, the company expects to produce up to about 5.0 million tests a week, with about 1.5 million tests currently in stock.
TX-based Everlywell Inc. reports that it is able to ship 30,000 COVID-19 tests and plans to expand the number of labs processing samples. It is a swab-based test that offers results within 48 hours. The company hopes to scale up to offer enough kits to test up to 250,000 people per week. The company is working on creating tests that rely on different sample collection methods, since there is currently a global shortage of the nasopharyngeal swabs used in COVID-19 tests. The tests are designed to be home test kits, but they are prioritizing early shipments to frontline healthcare workers.
MA-based Hologic Inc. reported on March 16 that it had received EUA approval by the FDA for its Panther Fusion SARS-CoV-2 assay. The test is a molecular diagnostic test that detects SARS-CoV-2, the virus that causes the disease known as COVID-19. Hologic’s system provides results in less than three hours and can process up to 1,150 tests in a 24-hour period. The company estimates that it will be able to produce 600,000 of these tests in April.
DiaSorin Molecular LLC
On March 13, CA-based DiaSorin was awarded $679,000 in funding to rapidly develop its coronavirus test, called the Simplexa Covid-19 Direct Assay. The funding was provided through the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services (HHS), through a process known as an easy broad agency announcement (EZ-BAA). EZ-BAA was launched to support commercial coronavirus diagnostic test development. The test received EUA from the FDA for this test on March 20.
MD-based Qiagen LLC has received $598,000 from BARDA’s EZ-BAA process. Qiagen is developing a test called QIAstat-Dx RPS2, that will be added to its existing QIAstat-Dx Respiratory Panel and is able to produce results in about one hour. This test has received Emergency Use Authorization (EUA) from the FDA as of March 24, 2020 and shipments to the United States have begun.
UT-based Co-Diagnostics produces the Logix Smart COVID-19 test, which is designed to run a variety of platforms and produces results within two hours. A change in FDA policy will allow test kits to be made available to labs in the United States without first gaining EUA by the FDA. It was also one of the first US companies to receive approval to distribute its tests in Europe and India. The company estimates it will be able to produce 50,000 or more of the tests daily.
On March 26, 2020, NY-based Henry Schein announced that their test kit known as Standard Q COVID-19 IgM/IcG Rapid Test is now available. This test is an antibody rapid blood test, which can deliver test results within 15 minutes using a blood from a pinprick and no other special instrumentation. By the end of March, the company was aiming to have several hundred thousand tests available and plans to significantly increase the number of available tests throughout April.
FDA alerts consumers about fraudulent COVID-19 test kits
The FDA has been reminding consumers that at the time, they have yet to approve any COVID-19 tests for home use. Any claims of a home test kit that consumers can purchase are fraudulent and can pose a serious health risk to those who purchase them.
Europe finds Chinese-made test kits inaccurate
Concerns are arising that test kits provided by Chinese companies and purchased by European countries are proving to be faulty, failing to properly detect COVID-19 in its early stages.
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