26 March 2020

Molecular Diagnostics' Finest Hour.

By Nathan Rigby By Nathan Rigby

COVID-19 is one of the biggest challenges healthcare has ever faced. It’s now a global pandemic, having spread to more than 160 countries and claimed thousands of lives.

While Europe is now at the epicentre of the crisis, the US is also facing a surge in cases and China has been heavily affected too.

Diagnostic testing is crucial to limiting the spread of the virus. When people know they’re infected, they can self-isolate. Results can also help us further understand the disease, helping governing bodies take evidence-based action to combat the spread.

So far, 16 (probably more by the time you’re reading this) COVID-19 detection products have been FDA/CE approved and are on the market. Identification times are getting quicker and productions rates are increasing.

While Meridian Bioscience were the first to provide a test for the virus with their immunoassay, it’s been the molecular diagnostics space that’s continued to innovate and contribute.

Molecular diagnostics tests for COVID-19 work by the detecting nucleic acids in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This can be done with either nasopharyngeal (nasal) or oropharyngeal (oral) swab samples.

Of these molecular tests, Cepheid have provided the biggest breakthrough with their Xpert Xpress SARS-CoV-2 test. Producing results in just 45 minutes, this test diagnoses at the point-of-care (POC) which means it can be used effectively on the frontline in hospitals and emergency rooms. Until Cepheid, this hadn’t been possible. Tests had to go through centralized labs and could take days to produce results.

Cepheid’s test is also easy to use. It can be administered by doctors and nurses with minimal training (they just need to take a swab).

The US company’s test received FDA approval on Friday 20th March and will be rolled out on Monday (30th March). The pace that this test has got to market is credit to FDA and its Emergency Use Authorizations, which have allowed speedy approval processes for multiple COVID-19 detection products.

These emergency conditions also saw the approval of BioFire Defense’s COVID-19 test, days after Cepheid. This test also detects SARS-CoV-2 in approximately 45 minutes with similar POC benefits.

Roche have also been a very active member of the life science community in this pandemic. They were one of the first to market with their rapid detection kit, many of which they donated for free to affected regions in China.

Their cobas SARS-CoV-2 Test was also the first of the FDA’s Emergency Use Authorization for a commercially developed COVID-19 test. Again, fully cooperative, the FDA cleared this test within 24 hours of receiving the company’s application and allowed Roche to ship the kits to labs ahead of time to prepare for the launch.

While Roche’s test is not as quick as Cepheid’s or BioFire Defense’s - delivering results in 24 hours – the company are still making a major contribution to combat the pandemic. This is especially true in the US, where the situation is rapidly escalating. Roche have now shipped 400,000 of their tests to the US and have vowed to continue this weekly.

There’s so much more crucial work that’s been done and is being done throughout diagnostics – this is the industry’s finest hour. However, cases are still on the rise. More POC kits must be produced to support frontline healthcare, so we can limit the spread as much as possible and beat COVID-19.

While there’s still work to be done, I’d like to take this chance to thank everyone who’s contributed to the cause with their molecular tests at their respective companies: PerkinElmer, Mesa Biotech, Primerdesign, GenMark Diagnostics, DiaSorin Molecular, Abbott, Quest Diagnostics Infectious Disease, Quidel, Hologic, Luminex,, Cepheid, Roche Diagnostics, Biomeriux, BioFire Defense, Thermo Fisher Scientific, Wadsworth Center, New York State Department of Public Health's (CDC) and Centers for Disease Control and Prevention's (CDC). I'd also like to thank everyone else working within global healthcare to combat the pandemic.

Please give me an email if I’ve missed anyone’s company out.

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Nathan Rigby

Nathan Rigby works globally, specialising in technical and non-commercial positions in in-vitro diagnostics. He enjoys exploring the humanitarian benefits of IVD, such as within the development of new rapid diagnostic tests for infectious diseases.

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