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As the COVID-19 pandemic escalates, companies across the world are preparing to roll out commercial test kits for the detection of SARS-CoV-2.

In the US, the Food and Drug Administration has issued Emergency Use Authorizations (EUAs) to approve tests for the coronavirus. This allows temporary use of novel devices in emergency public health emergency situations.  On 17 March, the agency announced a new guidance that will allow state laboratories to develop tests and FDA is allowing commercial manufacturers to begin distributing tests to labs while the manufacturer is preparing the EUA application. (Also see "Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process" - Medtech Insight, 17 Mar, 2020.)

On 12 March, Swiss groupRoche Molecular Diagnostics was the first commercial developer to secure an EUA. (Also see "Roche Launches COVID-19 Test For Cobas System; BioMérieux Plans Three COVID-19 Tests" - Medtech Insight, 13 Mar, 2020.)

The company was closely followed by Thermo Fisher Scientific Inc., which received an EUA for the TaqPath COVID-19 Combo Kit on 13 March.

Other companies that have obtained EUAs for SARS-CoV-2 tests include: Abbott Diagnostics for the RealTime SARS-CoV-2 Assay; Hologic Inc. for the Panther Fusion SARS-COV-2 Assay; LabCorp for the COVID-19 RT-PCR test; Quidel Corp. for the Lyra SARS-CoV-2 Assay; and Quest Diagnostics Inc. for the Quest SARS-CoV-2 rRT-PCR.

BD Biosciences could be the next in line after submitting an EUA application on 17 March for a COVID-19 test with molecular diagnostics company BioGX that runs on its BD Max diagnostic platform.

Earlier this month, LabCorp and Quest announced they will offer testing for COVID-19 to increase screening capacity in the US and the Mayo Clinic in Minnesota is making its PCR test for the virus available to health care providers. (Also see "Mayo Clinic Launches COVID-19 Test; Results Within 24 Hours" - Medtech Insight, 13 Mar, 2020.)

A UK-based laboratory, Mologic is also working with scientists in Senegal to make a handheld diagnostic test for coronavirus that can produce test results within 10 minutes.

Berlin-based lab TIB is reported to have produced 40,000 coronavirus diagnostic kits, enough for about four million individual tests, since the outbreak began.  (Also see "More German Companies Get To Work On COVID-19 Diagnostic Test Development" - Medtech Insight, 3 Mar, 2020.)

The Korea Centers for Disease Control and Prevention has approved four detection kits developed by domestic diagnostics companies.

New testing programs have also emerged. Alphabet-owned health company Verily Life Sciences LLC announced Project Baseline, a new pilot designed to guide people toward local coronavirus testing in the California Bay Area. People interested in being tested for COVID-19, complete an online screener based on guidelines from public health officials. Based on the responses and testing appointment availability, they will be contacted if they qualify for testing through the program.

 

COVID-19 Tests With US FDA Emergency Use Authorization As Of 19 March

On February 4, 2020 the FDA first issued an EUA for the Centers for Disease Control and Prevention's (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.
  • Roche Molecular Systems - cobas SARS-CoV-2 test
  • Thermo Fisher Scientific - TaqPath COVID-19 Combo Kit
  • Hologic - Panther Fusion SARS-CoV-2
  • LabCorp - COVID-19 RT-PCR
  • Quidel – Lyra SARS-CoV-2 Assay
  • Quest - Quest SARS-CoV-2 rRT-PCR
  • Abbott - RealTime SARS-COV-2 

Testing Supply Still Limited

All tests currently being used to detect COVID-19 infection are based on upper respiratory tract samples using real-time reverse transcriptase polymerase chain reaction (RT-PCR) technology.

The availability of testing is still limited in many countries, including the US.

The CDC expects many people with the virus will need to be managed symptomatically. Until the availability of tests increases, only people with evidence of respiratory tract infection are being tested.

The current priority for testing is people at greatest risk, including older people and those with underlying health conditions, such as diabetes or heart and lung complications. Patients testing positive are being advised to stay home until they've had two negative swab tests 24 hours apart, after symptoms have subsided.

The American Society for Microbiology (ASM) said the SARS-CoV-2 PCR reagents are in short supply. ASM membership includes the thousands of public health and clinical laboratory microbiologists who are on the front line of testing for COVID-19.

“We are deeply concerned that as the number of tests increases dramatically over the coming weeks, clinical labs will be unable to deploy them without these critical components,” ASM wrote in a statement on 10 March.

In the UK, Anglo-French company Novacyt SA struck a deal with Public Health England to supply its Primerdesign COVID-19 tests. According to the company, eight hospitals have ordered enough stock for four weeks of planned testing. The total value of the initial purchase is approximately £1m ($1.16m).

 

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