The BiosearchTech Blog

It may seem strange that a company known for transforming the global seed breeding industry is uniquely positioned to help COVID-19 testing labs overcome bottlenecks and rapidly scale-up testing. However, when you look at the problems testing labs are facing, it becomes clear that LGC, Biosearch Technologies has all the right tools for a rapid and robust pandemic response, even with the need to validate our Research Use Only (RUO) products for diagnostic testing. Today’s significantly altered conditions require new approaches and new solutions.

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We’re not rejecting you, just your oligo

PCR is arguably one of the most enabling technologies of modern molecular biology, with a sensitivity that can detect incredibly small amounts of DNA. However, the sensitivity of the method is also one of the biggest challenges—when you can detect just a few molecules of DNA, inadvertent contamination can give you misleading data. Issues with contamination are especially critical in qPCR reactions for molecular diagnostics testing, such as for SARS-CoV-2 detection, where any contaminating template DNA, even if it’s just long fragments, can generate false positive results.

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On March 25, 2020, the US Food and Drug Administration (FDA) held the first of a series of virtual town halls they will be holding to answer technical questions about developing, validating, and implementing tests to detect SARS-CoV-2. Elizabeth Hillebrenner and Timothy Stenzel, PhD, from the Center for Devices and Radiological Health (CDRH) provided an overview of the policies governing the development and deployment of SARS-CoV-2 tests as well as expanded guidance on the existing policies. One of the more interesting points they covered were the different scenarios where diagnostic test developers do not need to file for an emergency use authorisation (EUA), which the FDA put in place to expedite increased testing capabilities. We’ve summarised those scenarios here, although we recommend you use the links at the end of this post to see the source material from the FDA if you are considering any of these pathways.

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In the nearly three months since the first confirmed case of COVID-19, the outbreak has become a global crisis, with the World Health Organization (WHO) reporting 113,702 confirmed cases of COVID-19 as of March 10, 2020, with 80,924 of those cases in China and the remaining 32,778 cases spread across 109 countries¹.

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As the COVID-19 pandemic challenges society with the largest public health crisis of modern times, testing is a crucial part of the response. In the United States (U.S.), getting tests into the community has been challenging, in part due to the need to obtain an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA); however, in recent weeks, the US government has been doing its best to partner with private industry where the FDA has been fast-tracking more EUAs in effort to making testing more widely available across the country.

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Coronavirus, or COVID-19, is an infectious virus that is spreading rapidly around the world and the World Health Organisation (WHO) declared the outbreak a global health emergency within weeks of its identification. As of 11 March, WHO announced that the Coronavirus outbreak has become a global pandemic.

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