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Mara Aspinall is a legend in the diagnostics community. She has led, bought, and built companies that contribute to driving innovation in this space. She sits on the board of several organizations, contributing to the strategic plans of companies driving the development, delivery and data in the life sciences and healthcare arena. She co-founded a school at Arizona State University in biomedical diagnostics to educate and inspire future diagnostic leaders. She has mobilized a team of research experts to build the largest, global COVID-19 testing database. And she is just getting started.

Diagnostics are the least appreciated and least understood part of the healthcare spectrum.

I want to change that.

Mara’s passion for diagnostics began 20 years ago when she read a study showing 20-30% of patients at autopsy were found to be treated for a disease that they did not have. Getting a correct diagnosis is imperative. We cannot cure every disease today, but we can do our very best with the treatments we have available. But if the diagnosis is not accurate or timely – it does not matter how good If our healthcare professionals are not aware, or do not know what disease to treat, it is not good enough. This data propelled my career in diagnostics.

We sat down with Ms. Aspinall recently to discuss current, critical topics in the world of diagnostics and the spotlight COVID-19 has shone on the foundation of healthcare.

Data and the Hospital Lab are Critical to the Future of Diagnostics

Labs today are an information business with a wet lab on the side. The cost of the technology has gone down enough that virtually every lab can implement virtually every technology. It is the data that the lab brings to analyze its results on an individual patient basis and on a broader basis that is the change. Data also changes the way you hire people, and the economics of a lab. Mark my words, in five years we will be hiring more biostatisticians than lab technologists.

Technology has also reduced in physical size, changing the need for space in the hospital lab. A hospital lab can now execute and analyze a larger number of tests with more technologies at lower cost than they could even five years ago. Clearly there are some tests and technology that will stay at the central lab, but I believe that you will see hospital labs remain critical centers for testing.

 How COVID Turned the Spotlight on Diagnostics

At the beginning of this pandemic, diagnostics were under appreciated. The discussion was all about creating a vaccine and treatment with little attention paid to the diagnostics. What we have learned is that diagnosing patients as early as possible, even asymptomatic patients, is essential.  Testing enables us to create the right circle of care – test, trace, treat – it all starts with diagnosis.

Mara identified several specific aspects of COVID-19 where it is critical to integrate diagnostics.

1. Genetic Testing
   • Predisposition to contract disease and severity based on genetic makeup
2. Active Disease Testing
   • In Symptomatic and asymptomatic people
3. Antibody Testing
   • In recovered patients – to confirm that they have produced antibodies to SARS CoV2
   • In hospitalized patients to assess disease status – whether the patient’s immune system is creating antibodies to fight against the virus
   • In potentially exposed persons – to confirm whether or not a person has been infected and recovered
4. Use of diagnostics to prevent future pandemic(s)
   • We need a resource, like the COVID-19 Test Availability and Result Tracking Network developed by Accumen, to identify signals of the SARS CoV2 mutating and of future pandemics. Nothing is more important to manage a healthcare crisis than accurate, timely and data intensive use of diagnostics.
5. Understanding the economic impact
   • If people are scared, they do not go out or spend money. I want to talk about COVID-19 myths and facts to reduce the fear. Talking about what diagnostics can and cannot do will allow people to make educated decisions with their healthcare providers on which test is best. (Look for Mara’s new podcast series on COVID Myths and Facts at healthcareperformanceinsider.com in July.)

A Vaccine is NOT the Complete Answer

Diagnostics are incredibly important in determining whether the virus has gained or lost virulence. Many viruses mutate over time, which is why you need a flu vaccine every season. We need to understand whether this virus is changing in meaningful ways. Diagnostics are the only way to look at how a virus is mutating or changing over time. We already know that many SARS CoV2 strains in the U.S. came from Europe and are different from the original strains in China. We need to ensure that diagnostic companies work together to aggregate data, through a broad integrated lab network, so we can draw the right conclusions and develop preparedness plans moving forward.

Putting our Heads Together: Global COVID-19 Diagnostics Summit

In partnership with Arizona State University, Mara brought key healthcare thought leaders from around the world together last month. We did not talk about treatment. We did not talk about vaccines. We talked about diagnostics and the top six challenges that exist in making tests broadly available today.

Top six challenges:

1. Defining appropriate use cases / protocols for each type of test
2. Expanding testing for diagnosis (active infection)
3. Expanding screening for antibodies (prior exposure)
4. Engaging private industry in testing solution development
5. Contact tracing while still protecting the rights of individuals
6. Post-pandemic data analysis

From significant collaborative discussions came two major action steps the group is now working on in coordination with the Rockefeller Foundation and World Economic Forum, engaging both profit and nonprofit organizations in solution development. (More on this in the upcoming podcasts).  One that Mara and her team of researchers have made strong inroads on already is, analytics.

My team has put together a database of COVID-19 tests, capturing over 1,000 different tests being used globally to-date – about 60% identify the virus, 40% look for antibodies.

Given this is a global pandemic, tests are being sourced from all over the world – about 60% from China or other Asian countries, 30% from the U.S. and 10% from various other countries. Whether companies looking for lab partners or labs looking to access additional tests, it is critical we understand which tests are available, if and how they are approved for clinical or research use.

Diagnostics are the foundation from which all pillars in healthcare are built. Diagnostics tell us where needs for treatment exists. Diagnostics assist clinicians in determining accurate diagnoses. Diagnostics reveal the impact of new therapies and interventions. This circle of events continues as we find new diseases, new cures and therapies, and new patients that need treatment. And there is only one consistent element influencing the next step in the chain, every step of the way: diagnostics. Mara knows it and healthcare is learning. Let the spotlight shine bright.