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Precision Mobile Testing Is Key to Opening the Economy Safely

We are fighting an unconventional, asymmetric world war against an invisible enemy—a war which could continue for another 18 months. COVID-19, like the 1918 influenza pandemic, could have multiple phases of resurgence. Great American wars have been won through technological innovation. America can and will win this war on COVID-19, and against future pandemics and biowarfare attacks, by upgrading its national security and health care infrastructure, which has not changed much in almost 40 years.

The COVID-19 pandemic has exposed critical gaps in our current testing infrastructure. With currently available testing technologies, less than 5 percent of Americans have been tested so far. But to reopen the U.S. economy and rehabilitate industries, we will need widespread community-based precision testing of hundreds of millions of people. We will need to establish COVID-free safe zones for work and travel. This means people will need to be tested repeatedly with high-precision, mobile tests. To restore public confidence, the testing technology must be accurate and precise; this means that there should be no false negatives and no false positives.

Our current systems for diagnosing diseases like COVID-19 relies on a 400-year-old antiquated paradigm of centralized health care delivery, focusing primarily on testing sick patients at hospitals or clinics. In an age of cell phones and self-driving cars, we find ourselves fighting a global pandemic with inadequate armament and intelligence. This is much like fighting World War III with a musket.

NOT ALL TESTS ARE CREATED EQUAL

We are witnessing, almost daily, an increasing number of tests being added to our toolbox for detecting COVID-19. However, not all tests are created equal.

The most accurate testing for COVID-19 on the market today is enabled by molecular diagnostics, based on a 35-year-old technology called PCR (an acronym for polymerase chain reaction). By exponentially amplifying the SARS-CoV-2 viral RNA, this technology is typically capable of detecting the presence of even a small number of viruses in a sample with high sensitivity and specificity. The manufacturers of these PCR machines and reagents, as well as the centralized lab service companies, have made significant efforts to increase their throughput to provide hundreds of thousands more COVID-19 tests nationwide, but confined mostly to hospitals, labs and clinical settings. This centralized testing system requires large bulky machines and extensive overhead infrastructure, complex sample transport logistics, highly trained personnel, high volumes of expensive reagents and centralized lab facilities. This system does not lend itself to providing widespread and recurrent testing for hundreds of millions of people.

The holy grail of testing has long been touted to be point-of-care (POC) testing that bypasses the need of a centralized lab infrastructure and complex logistics. The most common POC testing currently available on the market today are serology tests or immunoassay tests that detect the presence of antibodies. These immunoassays could be used to map out individuals as they build up antibodies to the SARS-CoV-2 virus and to conduct further research to determine if people are gaining immunity after exposure and which antibodies, if any, may confer immunity to these patients.

These POC serological tests, despite being quick and cheap, are limited in their use as a screening test, because they intrinsically suffer from a high rate of “false positives” and “false negatives” and still require gold standard PCR confirmatory testing in centralized labs. Each individual returning to work or resuming travel with a “false negative” test becomes an unidentified walking bioweapon, who has the potential to infect thousands of others and induce millions of dollars of damage to our economy. Each person with a false positive screening test likewise creates panic and further burdens our already overwhelmed health care system.

Some of the large manufacturers of conventional PCR machines and reagents have made significant strides in introducing smaller and faster versions of their traditional PCR machines, reducing their size from 400 pounds to 6–40 pounds and hence bringing them closer to POC. This is a very good step in the right direction, but the ability to truly decentralize these machines outside of a lab or hospital setting will involve overcoming critical engineering barriers to achieve target performance metrics of accuracy, precision, speed, smaller sample sizes and user-friendliness. The quest to make these traditional molecular diagnostics systems smaller and faster is intrinsically limited by a glass ceiling of fundamental constraints imposed by physics and engineering.

NANOBIOPHYSICS REWRITES RULES

As a physicist and physician, I have spent the past few decades developing breakthrough technologies at the nexus of physics, biomedicine, and nanotechnology. With the help of awards from agencies like DARPA, DOD, DOE, NSF, my research lab at the Nanobiosym Research Institute has demonstrated advanced capabilities to control molecular reactions at the nanoscale, thereby enabling faster and smaller, IOT-connected, precision-engineered diagnostic devices like our X Prize–winning Gene-RADAR technology.

We harness the latest tools of physics and nanotechnology to enable faster, smaller, higher precision testing, unlike traditional molecular testing approaches that rely primarily on tools from chemistry and molecular biology. The science of nanobiophysics provides a quantum leap in testing capabilities, enabling increased mobility with real-time results while maintaining gold standard performance, but without the infrastructure, logistics and overhead requirements of traditional centralized labs.

Even as we continue to unlock the full power of the new science of nanobiophysics, we should immediately start building a new generation of technological infrastructure in our nation. This will help reopen our economy and get Americans safely back to work, across all industries, without endangering public health and safety. This will restore travel and trade by rehabilitating ailing industries including airlines, retail and hospitality. Anybody who wants a test should be able to easily get one.

Our nation’s highly developed but centralized testing infrastructure has simply not been set up to provide decentralized precision testing on a mass scale, as Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledged in a White House press conference. Our current system focuses chiefly on testing sick people in a clinic or hospital only after they show symptoms, and is based on an outdated paradigm of centralized health care delivery that was developed in the industrial revolution. As such, it is grossly inadequate to protect us from COVID-19 and future pandemics and biowarfare attacks.

The longstanding inertia and barriers to entry in our health care system have delayed adoption of the latest diagnostic technologies, despite them being ready to scale. As a result, this comprehensive nanoscale precision testing is simply not yet available to our citizens. It took a Manhattan Project to bring the latest atomic physics technology to scale to win World War II. Today, we need a similar effort to scale up our latest advances in nanobiophysics technology to fight and win this World War III. History will show that this critical leap forward was the step that saved the economy and culture, and restored faith in the safety of our great nation.

Read more about the coronavirus outbreak from Scientific American here, and read coverage from our international network of magazines here.



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