{"id":298,"date":"2020-10-07T13:47:55","date_gmt":"2020-10-07T20:47:55","guid":{"rendered":"http:\/\/admin.acceleratingscience.com\/ask-a-scientist\/?p=298"},"modified":"2022-10-06T16:20:31","modified_gmt":"2022-10-06T23:20:31","slug":"developing-covid-19-diagnostic-test","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/clinical-conversations\/developing-covid-19-diagnostic-test\/","title":{"rendered":"What’s it like developing a COVID-19 diagnostic test?"},"content":{"rendered":"

On January 11, an internal email set the wheels in motion for an unprecedented effort within Thermo Fisher Scientific to respond to a new coronavirus outbreak. Today, Thermo Fisher\u2019s test is authorized for use in more than 50 countries, and tens of millions of assays have been run. The following Q&A, excerpted from a recent interview with Kamini Varma, Senior Director, Molecular Biology, provides an insider\u2019s view on the effort required to launch the Applied Biosystems\u2122 TaqPath COVID-19 Combo Kit<\/a>. Learn more about COVID-19 testing solutions.<\/a><\/p>\n

Question 1: How did this journey begin for you?<\/strong><\/p>\n

For me it started on January 11, which now seems like a lifetime ago. I was copied on an email from a colleague asking if we\u2019d heard anything about a new \u201cSARs-like\u201d virus emerging in China. We were asked if we could develop a diagnostic for it.<\/p>\n

\"KaminiQuestion 2: So, you had to start from scratch?<\/strong><\/p>\n

No. Fortunately we had already developed a respiratory panel in 2019, so we were already quite familiar with coronavirus and how to design assays to identify it. That didn\u2019t make the work ahead easy, but we were able to quickly mobilize to develop both single and multiplex tests. I guess you could say that over the years we\u2019ve been \u201cbuilding our muscle\u201d to be able to respond quickly and decisively to a pandemic like this, and it\u2019s a good thing we were.<\/p>\n

Question 3: What happened next? <\/strong><\/p>\n

By mid-February, our nearly round-the-clock development work had produced a viable assay that we felt was ready to begin the emergency use authorization (EUA) process with FDA, a first step in putting a test into the market for more widespread use. At the time we were unsure of the timeframe for the EUA process, but our reference point was Zika virus a few years ago, where our EUA process took nine months. But, given what was already happening in countries such as Italy, we knew we\u2019d need to find a way to accelerate the process.<\/p>\n

Question 4: So how did you accelerate the process?<\/strong><\/p>\n

It started with what I call the pivotal 10 days. From March 3 to March 13 we had our heads down in a \u201cwar room\u201d setting with about 20 colleagues from across our business: clinical and software experts. This included colleagues from other businesses who flew in overnight, often only catching a few hours of sleep in nearby hotels, to help with aspects of creating an actual test product for widespread distribution. We wanted to cover all bases, including bringing onsite the FSE to support any instrument issues that would ultimately be running the assays in the field. The coalescing of normally disparate businesses into one will be a model for mobilization moving forward.<\/p>\n

Question 5: Were you working closely with the FDA as well?<\/strong><\/p>\n

We and our regulatory team were in constant communications with FDA, sometimes hourly. We shared our studies in near real-time to ensure that nothing would slow the process. We submitted our EUA on March 12\u00a0and received authorization the next day. After that, we turned our attention to transferring knowledge to our manufacturing and customer support teams to ensure they were prepared to take our work to the next level of scaling production and lab testing for millions of COVID-19 tests. This included knowledge transfer to customers on the front lines. We also had to support regulatory team\u2019s efforts internationally who were working to secure authorizations to use our test in their locales.<\/p>\n

Question 6: What was the team\u2019s greatest challenge?<\/strong><\/p>\n

Accelerated development pace was important, but not at the expense of quality. Our assays are built on trust and rigorous development work, and we couldn\u2019t compromise there. That\u2019s where having the luxury of tapping colleagues from across Thermo Fisher \u2013 and ballooning our team to match the scale of the pandemic \u2013 paid off. Seeing tens of millions of tests successfully run worldwide while\u00a0delivering gold standard performance, is validation that we met our commitment to uncompromising quality while delivering on an unprecedented timetable.<\/p>\n

Question 7: What was your greatest challenge?<\/strong><\/p>\n

For me, and the entire team, this massive effort required personal sacrifice. We were unable to see our families and worked long hours. Fortunately, I and many others have supportive spouses who enabled us to focus on this one-in-a-lifetime challenge. Looking back, and even now as we scale up to test asymptomatic populations, simplify workflows, explore new sample matrices such as saliva and develop multiplex tests that combine influenza strains, it\u2019s the unity of purpose, not the challenge, I think about most.<\/p>\n

 <\/p>\n

To learn more about Thermo Fisher Scientific\u2019s COVID-19 Testing Solutions, please visit thermofisher.com\/covid19<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

On January 11, an internal email set the wheels in motion for an unprecedented effort within Thermo Fisher Scientific to respond to a new coronavirus outbreak. Today, Thermo Fisher\u2019s test is authorized for use in more than 50 countries, and tens of millions of assays have been run. 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