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COVID-19 Diagnostic Tests That Recently Secured FDA's EUA

pharma 051117 17mar20 lt

Diagnostics play a key role in combating a flu pandemic because the test results will help to know if a person has been infected by the virus and will also help to take measures to prevent the spread of infections. As the COVID 19 continues to sweep across the world, all the countries are racing to develop reliable diagnostic tests and also develop a vaccine or treatment against the novel coronavirus.

The diagnostic tests are performed on samples that are collected as swabs from a patient's nose and throat or as sputum and sometimes even on blood collected from a patient.

Let's take a look at some of the companies that recently received FDA's Emergency Use Authorization (EUA) for their COVID-19 diagnostic tests.

Hologic Inc. (HOLX)

Hologic's Panther Fusion SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes Covid-19, has been granted Emergency Use Authorization by the FDA.

The Panther Fusion system will use the nasopharyngeal (NP) and oropharyngeal (OP) swab specimens and can provide results in less than three hours and process up to 1,150 coronavirus tests in a 24-hour period.

Hologic expects to provide its laboratory customers with tens of thousands of SARS-CoV-2 tests this month as it ramps up production capacity. Starting in April, the Company expects to produce nearly 600,000 SARS-CoV-2 tests a month.

LabCorp (LH)

LabCorp's COVID-19 RT-PCR test designed to detect the virus that causes COVID-19 has been granted FDA's Emergency Use Authorization.

The test is intended for use with respiratory samples, including nasopharyngeal or oropharyngeal aspirates or washes, swabs, and broncheoalveolar lavage, and was launched on March 5, 2020.

Roche

Roche's cobas SARS-CoV-2 Test to detect SARS-CoV-2 was granted Emergency Use Authorization by the FDA last week.

This test is intended for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples of patients. The cobas SARS-CoV-2 Test can be run on Roche's cobas 6800/8800 Systems which can process up to 384 results (cobas 6800 System) and 960 results (cobas 8800 System) in an 8-hour shift. The test results are provided in three and a half hours.

Roche began shipping the initial 400,000 test kits on March 13 and will be completed this week. An additional 400,000 tests per week will be shipped by the Company to the laboratory testing sites across the nation.

This test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.

Thermo Fisher Scientific Inc. (TMO)

Thermo Fisher's diagnostic test TaqPath COVID-19 Combo Kit was granted Emergency Use Authorization by the FDA last week.

This test is used for the qualitative detection of SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.

Thermo Fisher currently has 1.5 million tests available to ship, and expects to quickly ramp up to reach 2 million tests per week. During the month of April, the Company is planning to scale up the production to up to 5 million tests per week.

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