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April 22, 2020

2 emerging solutions that could help reopen America

Daily Briefing

    As we approach the federal government's April 30 expiration date for social distancing guidelines, focus is increasingly shifting to opening up aspects of society to prevent economic collapse. But to safely get people back to work—and keep them there—will require creative solutions and collaboration between the diagnostics community and the rest of country.

    Is it time to loosen social distancing? Governors are sharply divided.

    Not only do we need a baseline understanding of existing immunity, we need ongoing, reliable access to testing at scale. While we're still a long ways off from national-level testing, we're beginning to see solutions emerge from public and private sector alike.

    Below we've highlighted two promising solutions.

    1) 'Immunity passports' to enable recovered individuals to re-enter the workforce at less risk than others

    Covid-19 "immunity passports" could enable businesses to start safely bringing employees back to work by identifying staff who have already recovered from Covid-19. Essentially, the passports would confirm that an individual has antibodies to Covid-19 and, therefore, may have built up resistance to it. As more serological tests gain FDA authorization in the United States, and as key stakeholders in the industry advocate the use of serosurveys, this strategy appears more and more feasible.

    In fact, New York Gov. Andrew Cuomo (D) announced that New York will begin testing first responders and health care workers for Covid-19 antibodies, with hopes to scale to additional essential workers across the state. Pending FDA authorization, New York aims to extend testing beyond state-run labs to increase capacity from 2,000 tests per day to as many as 100,000 tests per day.

    Despite the fact that tens—if not hundreds—of thousands of people in the United States have already recovered from Covid-19, antibody testing is just starting to ramp up. There are a few reasons why that's the case, and why additional research is needed before "immunity passports" could be issued. (Hint: the jury is still out on whether recovering from the virus confers immunity and how long immunity lasts).

    Ultimately, the United States will probably implement a broad methodology for providing proof of immunity, especially given interest from influential stakeholders (see past FDA commissioners Scott Gottlieb and Mark McClellan's report) in widespread serological testing. But we're not there yet.

    2) Employer solutions to conduct routine employee testing at scale in open sectors

    Reopening key sectors of the economy requires an increasing number of employees leaving social isolation to return to work. These employees face greater risk of infection, signifying a risk of renewed community outbreaks. This is where employers are stepping up: At one end of the spectrum, Amazon announced that they're building their own diagnostic lab to test workers for Covid-19. At the other end, employers are beginning to invest in outsourced testing solutions for their workforces.

    One such solution is presented by Los Angeles-based genomics company DxTerity Diagnostics. DxTerity will offer subscription-based SARS-CoV-2 testing to employers. According to DxTerity CEO and Founder Bob Terbrueggen, the idea of the "Keep America Working" solution is to provide reliable access to frequent, fast-turnaround (24 hours) testing to employers. This testing will enable them to closely monitor their workforce so that employees can safely return to—and remain at—work.

    Essentially, employees will self-collect samples at the worksite. Then, DxTerity will work with specialty lab partners to collect the samples and prepare them for analysis. Finally, DxTerity will conduct the back-end high-throughput analysis and return results to the employer within 24 hours. To avoid common supply shortages and raw material upcharges, DxTerity has contracted directly with swab and reagent manufacturers to guarantee supply. Their test relies on self-collection using a combination saliva and simple nasal swab collector that inactivates the virus for safe sample transport. The test is CLIA-validated and the company is seeking emergency use authorization from FDA. For logistical reasons, the test will be deployed as a workplace safety tool rather than a medical diagnostic tool. Terbrueggen projects that the lab will be able to process 20,000 samples per day by July.

    Long turnaround times at commercial labs have meant that standard testing is not an adequate solution for industries that must stay up and running through the pandemic. A natural place to turn next is point-of-care testing. "But," Terbrueggen points out, "if you're trying to test 100, 1,000, 10,000 people at the same time, point-of-care testing doesn't work. Those 15 minute-turnaround times add up."

    DxTerity's solution is to avoid bottlenecks at each step in the process and, in doing so, minimize logistical burden on both the employer and the lab. To begin, DxTerity's "Keep America Working" is aimed at capital-intensive industries considered essential, such as biopharma and lab. However, while it may not be financially feasible across the board—each test run costs $75—as mandated stay-at-home and work-from-home orders are lifted, more industries may look to implement similar solutions.

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