Companies Offering COVID-19 Testing Kits
ProcurementIQ provides a list of vendors offering COVID-19 testing kits
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. On April 3, 2020 the Logix Smart COVID-19 Test kit earned Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for the diagnosis of SARS-CoV-2. Co-Diagnostics 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. Co-Diagnostics only sells its test kits to labs, and the tests are only available to patients with a prescription.
On March 13, 2020 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, 2020. The test can be processed in just over an hour. The coronavirus test comes as a nasal swab, nasopharyngeal swab or via bronchoalveolar lavage (BAL).
TX-based Everlywell Inc. reported March 23, 2020 that it had already shipped 30,000 COVID-19 tests to frontline workers and patients in need. The company had planned to expand the number of labs processing samples. Its test is a swab-based polymerase chain reaction (PCR) test that offers results within 48 hours, or 3 to 5 days from purchase. 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, costing $109 each, but they are prioritizing early shipments to frontline healthcare workers.
MA-based Hologic Inc. reported on March 16, 2020 that it had received EUA 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 fewer than three hours and can process up to 1,150 tests in a 24-hour period. The company estimated that it was able to produce 600,000 of these tests in April. Hologic expected to initially offer 3 million tests to its laboratory customers as of April 29, 2020. At the end of May, the company anticipated the production of 1.0 million Aptima SARS-CoV02 assays per week. In the months to come, Hologic expects to continue raising production capacity for the novel assay.
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 process 20,000 tests per day. LabCorp can help facilitate testing of employees on-site through COVID-19 PCR tests, which detect an antigen, rather than antibodies, through a nasal swab. The turnaround time for tests is 2-4 days. LabCorp also offers a COVID-19 test for at-home sample collection, priced at $119 per test. LabCorp’s at-home sample collection was the first COVID-19 at-home test to be backed by the FDA. For asymptomatic employees, LabCorp offers COVID-19 IgG Antibody Testing services. As of May 12, LabCorp had more than 200,000 kits in inventory and was “prepared to significantly expand capacity as required.”
As of May 29, 2020 LetsGetChecked’s weekly capacity was 300,000 kits and it was building toward a capacity of millions of testing kits. LetsGetChecked only offers nasal swab tests for individuals conducting the tests in their own homes. As of June 8, the price of one at-home nasal swab test kit is $129. The test can be processed within 24 hours of being received by the lab.
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 EUA from the FDA as of March 24, 2020 and shipments to the United States from Germany have begun. The FDA has determined that Qiagen’s test is for research use only (RUO). The RUO designation, in effect, allows the test to be distributed to researchers who can subsequently determine if the product could have a diagnostic purpose. However, some assays never transition from RUO to diagnostic applications.
NJ-based Quest Diagnostics received 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 processing 25,000 COVID-19 tests per day and had reached 30,000 tests per day by the end of the first week of April. Quest announced May 28 that it would have more than 500,000 kits available by the end of June. Quest is prioritizing its self-collection kit for frontline workers, including first responders and healthcare workers. The average turnaround time for COVID-19 testing is 3-5 days. For its PCR tests, Quest is using the Quest lab-developed test (LDT), Roche and Hologic.
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, which followed an approval under FDA EUA. Roche 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. Roche Diagnostics does not administer COVID-19 tests.
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 its recently approved and distributed Applied Biosystems7500 Fast Dx Real-time PCR. The test kit allows for the evaluation of up to 94 specimens in 3 hours or 382 specimens in under 6.5 hours. The company is producing more than 5.0 million tests per week for global use, with about 1.5 million tests in stock as of April. Thermo Fisher Scientific only sells testing kits to clinical laboratories carrying out COVID-19 testing.
- Those self-administering tests will be asked to gather a sample from the front of their nose rather than the back of the nose (i.e. throat).
- The switch to nasal swab is supposed to result in fewer false negative tests due to better specimen collection.
- Harvard’s Global Health Institute estimates that the United States, as a country, should be carrying out more than 900,000 tests daily to prevent significant outbreaks from arising.
- Right now, only nine states have reached the target number of tests necessary, according to the Global Health Institute at Harvard. These states, which are primarily large states with sparse populations, are Alaska, Hawaii, Montana, North Dakota, Oregon, Tennessee, Utah, West Virginia and Wyoming.
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