Second article in LST’s “Through the Lens of” series features development of COVID-19 test

(EDITOR’s NOTE: The second installment in Life Science Tennessee’s series titled “Through the Lens of” features the story of how one company navigated the market volatility brought on by the pandemic to develop and launch a COVID-19 test. Jonathan Peat, Business Development Manager of QuantuMDx, describes their journey and predicts future testing needs. The article, written by Peat, is reposted here with the permission of the statewide association.) 

Without question the coronavirus pandemic has shifted the business landscape, creating opportunities for companies to pivot operations and help address an immediate public need. The foremost shift has been a result of market volatility coupled with the overall speed of business transitions. As both an observer and participant in that change, we should continue to take stock in what this novel time has taught us and consider its applicability to addressing future challenges for our industry and beyond.

Every day, life science companies around the world work to bring new technologies and innovations to market that will improve people’s lives. This is especially true for life science companies who have responded in force to the COVID-19 pandemic by developing therapies and treatments for patients suffering from the virus, including creating diagnostic tests to identify cases and prevent further spread and searching for preventative cures and vaccines.

My company, QuantuMDx, makes accessible, quality diagnostic tools that allow for the early detection of disease and consider the most challenging of circumstances. Before the pandemic, we were forging ahead with our launch plans for Q-POC™—a battery-operated point of care system. We planned to launch with an HPV test as our first assay and have it to market by early 2021 with a focus on developing countries where resources can at times be scarce.

In February, as the coronavirus spread and cases skyrocketed, we made a drastic decision to shift our immediate focus and develop a COVID-19 test. Specifically, our scientists developed a real-time reverse-transcription polymerase chain reaction assay to detect SARS-CoV-2. Our SARS-CoV-2 detection assay kit combines all required reagents into a single tube for convenience. The primary use for this test is in centralized labs, but we are in the process of establishing a simple point of care system as well, allowing our tests to be readily used with quick results anywhere in the world.

Our experience with the rapid development of the test and market strategy may be specialized, but there is broader applicability to lessons learned for any company dealing with accelerated timelines and unpredictable market conditions.

Among my observations of the early days of the pandemic response is that many in leadership were looking for easy solutions to complex problems. In diagnostics, some didn’t know or fully appreciate the difference between an antibody test and a molecular test. This large learning curve led to such unfortunate things as poor quality tests approved and introduced in the market due to extraordinary demands on governments. Unfortunately, this resulted in opportunism from unscrupulous vendors. It became clear in this early period that while attractive, the world needed more research, oversight and innovative thinking on the right approach to COVID testing.

Between mid-April and mid-May, things started to calm down. Social distancing and “Safe at Home” orders were effective in flattening the curve, and people understood (or believed) their government was taking steps to gather resources that would allow their cities to safely reopen businesses.

From a testing standpoint, China was swamping the market during this period. Most distributors were still promising exorbitant orders of 2 million tests. However, we began to see a transition; people started to ask for more strident tests and accept only 90% or better accuracy rates. We also started to see the availability of swab and RNA extraction kits normalize.

Since May, we have seen a lot of countries close down tests that were not developed in country in an effort to ensure testing quality. Some countries are even going so far as to shut their borders. We have also seen trusted companies regain their foothold over more unethical companies. Adding to this, there is the continued public conversation about track and trace and the need for more tests to ensure a safe reopening, thus continuing the market push.

As with other services that seek to meet urgent demand, going forward we expect to see early tests will be replaced by more accurate, timely tests. And companies will consider the market for testing in six, nine, twelve months and beyond. How do we employ testing at major transportation hubs or large outdoor venues like stadiums? What is the best way for large companies to test employees as they return to site? These types of questions are the questions that many companies have faced or will face, regardless of their industry.

Life science companies have the tools needed to solve this crisis. But it will take collaboration with the public and private sectors, along with an entrepreneurial spirit, to educate and continue to build trust in the science.

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