Knowledge is Power: Don’t Give Up on Diagnostic Tests for COVID19

Mike Pellini, managing partner, Section32

Let’s not mince words.

We are in the midst of the worst health care emergency since the flu pandemic of 1918-19 that killed 650,000 Americans and 50 million people worldwide. And, we are told that on the horizon may be the worst economic and unemployment crisis since the Great Depression.

These challenges are coming in biblical proportions, and yet the main strategies proposed thus far to combat the SARS-CoV-2 (COVID-19) virus have been non-pharmaceutical interventions. We are told to wash hands, and to do “social distancing” to “flatten the curve.” The US is struggling to provide even the most basic commodity gear for frontline healthcare workers. Personal Protective Equipment (PPE) is getting scarce. We have people using 3-D printers from home to make improvised face masks. The federal government, and state governments, are struggling to secure enough ventilators for  patients in intensive care, and the many more surely to come.

Incredibly, this is the case even after a decade of breathtaking progress in our biology, drug development, and the science and technology underpinning diagnostic tests.

But, here’s the really bad news, which we all need to understand: even if the non-pharmaceutical interventions we’re using now are successful and equipment shortages are solved in a consistent fashion across the nation, that’s not enough. If successful, those interventions will have some effect on easing the immediate challenge of reducing a spike in illness and lowering the death rate. They will also have a drastic effect on our economy. Because we know so little about this novel coronavirus, including the basics like how it is spreading and how it can and should be treated, we have to bring the full power of US academic and industrial science to bear.

It starts with diagnostic testing. Without fast, accurate and widespread testing across the country, the measures currently in place may well prove woefully inadequate.

Even as the virus rips across the country with exponential speed, pushing hospitals to the brink, we have seemingly given up on widespread implementation of diagnostic testing to identify individuals who have contracted COVID-19. Some hospital leaders, under wartime triage pressure, have argued that diagnostic testing is almost irrelevant, because this bug is so contagious and has been uncontained for so long, that’s it’s virtually impossible to run all the necessary diagnostic tests. They say we should prioritize resources toward protecting frontline healthcare workers from the coming surge of infected patients.

This is a mistake.

We have the technology and means to rapidly implement testing at a national level.

We must demand that our government apply urgent focus to the deployment of a national COVID-19 diagnostic testing program. Our scientists know how to do this. We have seen rapid progress in other areas of medicine. Our pharmaceutical, biotechnology and academic colleagues, coupled with the U.S. Food and Drug Administration (FDA), promptly committed to the timely development of antivirals to combat COVID-19, like Gilead Sciences’ remdesivir, a polymerase inhibitor. The National Institute of Allergy and Infectious Disease, in collaboration with mRNA vaccine developer Moderna, went from the discovery of the novel coronavirus to a vaccine candidate ready for first-in-human injections in just two months.

Now, our policymakers must learn that diagnostic testing and appropriate treatment and prevention go hand in hand. There’s no other path.

Imagine what’s possible with an all-out, national effort around diagnostic testing. We’ll be able to identify all the sick people — and the asymptomatic people — who are unwittingly spreading the disease. Once identified, the infected can be isolated until they are no longer  infectious. Once the cases are properly identified at large scale, local public health officials can do the tracing of those peoples’ contacts, and urge those contacts — even those without symptoms — to self-quarantine while they await test results to see if they, too, are positive.

This is the essential blocking-and-tackling of public health that must come simultaneously with national “social distancing” efforts to mitigate the spread of SARS-CoV-2. The testing and tracing program is absolutely central to a national suppression strategy.

Just yesterday, we saw a positive sign. Abbott Laboratories won emergency FDA clearance for a molecular point-of-care testing device that can deliver positive COVID19 test results in 5 minutes, and a negative result in 13 minutes. Abbott, a big company with the necessary people and resources to scale up to a national challenge, said it will make the device available this week and that it plans to ramp up capacity to 50,000 tests per day. This approval comes after recent advancements were announced by Roche and Thermo Fisher Scientific as well.

It’s a start.

But the overall picture remains discouraging. It’s late in the game. That approval came after we already have more than 100,000 confirmed cases in the US.

To date, there has been a failure of technology deployment and leadership because our society has not properly prioritized diagnostics to track the spread of this particularly virulent enemy, to understand its characteristics, and to reveal how different people respond to it. In fact, our national focus appears to have recently shifted from rapidly identifying patients through diagnostic testing to skipping the testing on the presumption that everyone with a COVID-19 exposure or flu-like symptoms is positive for the SARS-CoV-2 virus.

To forgo diagnostic testing in this context borders on malpractice at a national level.

We must instead immediately work to understand everything about this virus, from its geographical spread to how it manifests itself differently in individual patients. We need a national program where tests are made available in areas of critical need, like New York City, Seattle, San Francisco, New Orleans, Atlanta, Chicago, and Detroit. Only then can we truly understand how Americans might be treated appropriately and, where possible, prevented from contracting the virus.

As we deploy 100-year-old strategies to deal with this global pandemic, we must also supplement them with our best available digital technology. We need to collect the data generated by diagnostic testing to figure out how and where COVID-19 manifests if we are to slow its spread. These national data from broadly available tests could inform both the intelligent distribution of clinical care and the aggressive development of antivirals and vaccines.

Thankfully, the diagnostic industry has stepped up. Tests, including ones at the point of care like Abbott’s, that don’t require samples to be shipped by cargo planes to faraway labs, have been developed, approved, and manufactured in record time. But supply chains must also be fixed, and diagnostic tests need to be aggressively and broadly deployed to every local hospital in the country. Then the data need to be swiftly reported in a systematic way, so they can analyzed and integrated quickly into clinical care.

Without these diagnostic data, we are flying blind.

But here’s the good news: right now, we have the ability to put millions of tests into operation.

Here’s what it will take:

First, we must broaden the distribution network to allow our national, regional, and local labs to continue the work they are already doing in scaling up their testing capacity. We can’t rely only on large national labs like LabCorp, Quest, and the CDC lab in Atlanta, or academic centers like the University of Washington Virology Lab, which stepped in to fill a void in the Seattle area’s diagnostic testing capacity. We should also enable local clinical labs, which routinely work together to validate one another’s results, to go online withCOVID-19 testing.

Second, we need to get creative, while continuing to put patient safety first. Nasopharyngeal swabs are cheap, easy-to-use commodity supplies, as evidence by a recent Gates Foundation clinical study. They should be made available for in-home use immediately. Telemedicine approaches can allow the tests to be ordered, while individuals can sample themselves or family members and send the swabs overnight to the appropriate lab. Complete home diagnostic tests, while still new, can be deployed in a safe and effective fashion once they are validated. The Bill & Melinda Gates Foundation recognized this opportunity and has been supporting work along these lines.

Third, the FDA and Centers for Disease Control and Prevention (CDC), in conjunction with the national, state, and local governments, must work together to promote the process and cooperation. This means speaking clearly, calmly, and forcefully on the national stage about why we need to do a better job of diagnostic testing, and what real success would look like. A National Diagnostic Testing Czar for COVID-19 should be appointed immediately to oversee these efforts.

Fourth, testing priority must be given to health care providers, the elderly, and populations with co-morbid conditions, and anyone expressing symptoms. Of course, as we ramp up and reduce the bottlenecks, we can broaden testing criteria to include the general population rapidly.  

Fifth, the results from all COVID-19 tests should be uploaded to a central database, allowing epidemiologists to make intelligent decisions about quarantines and the allocation of care, instead of guessing where and whom the virus is going to strike and imposing blunt “shelter-in-place” mandates across ever-wider geographic expanses. Individuals who test positive could be quarantined without closing down the entire economies of states and the nation, as is the case today.

A coherent diagnostic testing approach will yield data that will inform our ability to combat COVID-19’s spread strategically and over the months to come. In the immediate term, it will help to target isolation approaches where they are needed and allow COVID-19 negative patients, to return to work. These tests will also alleviate patient angst while at home. They will help us stratify COVID19 patients, so they can stay in hospital areas away from other patients.

In the medium-term outlook, the next 2 to 4 months, the data will teach us more about the clinical manifestations of the virus, yielding information on individuals who have been exposed in the past, perhaps without symptoms, those who are at greater risk for aggressive forms of the disease (smokers, diabetics, etc.), and even those who have developed immunity. And, in the longer term (6 -18 months), the information will assist with the development of essential therapeutics and vaccines.

We must not give up on broad-based diagnostic testing. It is the foundation to overcoming this pandemic in every country.  The playbook is already in hand if we choose to engage.

Once upon a time, Americans understood that knowledge was power. It still is. And, in this case, knowledge comes from utilizing diagnostic testing, not ignoring it.

Michael Pellini, M.D., is managing partner of Section 32, a venture capital firm. He’s also a board member of the Personalized Medicine Coalition.

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