The Importance of Testing: Now More Than Ever

By Jack Stover

Throughout my career working as a CEO for several therapeutic companies, I’ve witnessed and even marveled at some incredible medical breakthroughs and advances that at one point, may not have seemed possible, not in this lifetime anyway.

AI is now being used in the early detection and diagnosis of many diseases to cut costs and drug development time drastically. Genomic research has paved the way for treatments tailored to a specific patient’s genetic make-up. Thus, gene-editing technology, such as CRISPR, has successfully removed a heart disease defect in an embryo. And immunotherapy is giving cancer patients, like former President Jimmy Carter, a second chance at life, even at the age of 91.  

These treatments are a lifeline for so many people. Yet now we are grappling with a new problem: A pandemic, that is not singling out any genetic make-up, or discriminating based on a person’s age, ethnicity, or geographical location. No one is immune to COVID-19. At this writing, there are dozens of clinical trials underway for new therapies and vaccines. But a new therapy to treat the virus, or even a vaccine to prevent it, are only part of the solution. Without adequate testing, a second wave of this highly infectious virus, will be just as deadly and costly to our global economy, as the first wave.

Look No Further Than the AIDS Epidemic

Exactly two decades after the Centers for Disease Control documented the first AIDS patient in the US in 1980, there is still not a cure for AIDS.

And now during the midst of another public health-challenge we find ourselves asking some of the same questions we asked during the AIDS outbreak.  How close are researchers to developing a vaccine, and will a single therapy or even a combination of many therapies actually slow the spread? Will we be able to slow the spread by adequately testing those showing symptoms, before even more people become infected?

It took 15 years after the first AIDS diagnosis in the US before anti-retroviral therapies became the new standard of treatment for AIDS. It was a cocktail of drugs, known simply as ART, but it was a game-changer, cutting the death rate in half.

Approximately 7 years after ART was introduced, the Food and Drug Administration approved the first rapid HIV diagnostic test kit in November 2002. This test kit allowed hospitals to provide results with almost 100% accuracy in just 20 minutes time. Some doctors estimate that during the AIDS epidemic, testing reduced the spread by as much as 85%. A positive test result meant people took the necessary precautions known to spreading the disease.

New therapies, more testing and behavioral changes were all part of the prescription for mitigation during the AIDS pandemic, safer sex then, quarantine and lock down orders now. While all of these steps are necessary, we learned during the AIDS crisis that neither therapy, behavioral adjustments, or testing alone will stop transmission. What will slow the spread is containment, or more drastic measures known to those who have the virus, but this requires testing.

Without Testing, We’re in The Dark

There is plenty of blame to go around criticizing the country’s response to COVID-19, the bulk of which may center on testing. Initially, the CDC guidelines limited who should be tested. Then in early February, there was an issue with the test kits. Some labs were reporting to the CDC that test kits were flawed. The faulty test kits combined with the country’s slow start to test left communities paralyzed by the inability to control the spread. It’s easy to look back.  Instead of focusing on keeping the virus out of this country, mitigation efforts should have been a priority. We should have adequately planned for a pandemic, prepped the hospitals and increased diagnostic testing. There will be a time to assess many more missteps. For now, efforts should focus on adequate testing. Without it, we remain paralyzed.

Two Types of COVID-19 Tests

Since the disease outbreak, clinicians have been using the polymerase chain reaction (PCR) test to detect the virus’s genetical material on a nasal or throat swab. This test identifies whether someone has an active infection. The slow rollout of this test is attributed to rules ensuring its’ reliability and the collaboration with health care companies designated to develop and finance the tests. While the PCR test is now considered accurate for the most part, the turn-around time for getting the results can take 2 to 4 days. And in that finite amount of time, many people may have already infected others.

The second type of test is serological testing, which looks for the presence of antibodies produced by the immune system against COVID-19. A simple finger prick of blood on a test strip, could possibly identify people who previously had the virus and have developed some immunity to it.

Some scientists say these serum studies are the key to understanding the amount of infection in the community. They are designed to retroactively collect data, which could mean the difference between staying at home or re-entering society.

A Global Effort

The World Health Organization has repeatedly said that testing is the key to stopping the spread of COVID-19. Diagnostic testing, along with the quarantine of those infected, contact tracing, and quarantining of those contacts, worked in slowing the spread in South Korea.  Early on the country witnesses how contagious the virus is and how quickly the virus spread from Wuhan. The country had a system in place. They prioritized identifying and isolating those who tested positive, and eventually developed the ability to run thousands of diagnostic tests a day. They were the first to enact free drive through testing booths. Other countries followed their lead.

Scientists know this virus is much more deadly than a seasonal flu and that a person will develop some immunity after being exposed, but when that immunity occurs and how long it will last are all unknowns. There are slightly different strains of this virus, just like any other corona virus, or cold virus. Potentially a person could be exposed to a different strain and get sick again.

In order to relax social distancing, we need to test quickly and accurately, within 5 or 15 minutes, to determine if a person has been exposed, recovered, or whether they are actually infected. Currently (article written in early May 2020), the CDC estimates 1 in 4 people show no symptoms of the virus. Researchers in Iceland estimate its half. Regardless of where you live, the answer to slowing the spread is the same. We must figure out who is protected against the disease. That’s the first step in getting people back out into the world.

Jack Stover is the CEO of Interpace Biosciences.