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TGen North and COVID-19

DR. DAVID ENGELTHALER CO-DIRECTOR AND ASSOCIATE PROFESSOR OF THE PATHOGEN AND MICROBIOME DIVISION

3051 W SHAMRELL BLVD FLAGSTAFF, AZ 86005

WHAT IS TGEN NORTH?

TGen North, formally called the Pathogen and Microbiome Division, is the infectious disease division of the Phoenix-based Translational Genomics Research Institute (TGen). The lab is located in Flagstaff, a few miles south of downtown. TGen North is equipped with the latest in technology for identifying and analyzing fungi, parasites, bacteria, and viruses, such as the one that causes COVID-19 — the SARS-CoV-2 coronavirus. In addition to research laboratories, it’s home to a new state-of-the-art CLIA-certified clinical laboratory and a Bio Safety Level 3 laboratory.

WHAT IS A CORONAVIRUS?

The coronavirus causing the current pandemic is one of many coronaviruses, some of which are known as human coronaviruses and cause relatively minor symptoms associated with the common cold, while others are zoonotic viruses (which come from animals) like SARS and MERS, which cause more serious, potentially deadly diseases. Our current battle is with the highly contagious SARS-CoV-2 virus, which causes the COVID-19 disease, for which there is no proven treatment.

WHAT IS TGEN NORTH’S INVOLVEMENT WITH COVID-19 ?

TGen North is involved in many different ways: We have developed our own highly accurate PCR test to diagnose those who are infected. We are the cofounders of the new Arizona COVID-19 Genomics Union, which is working to track the virus, where cases are coming from and how it is circulating in the community, by using Whole Genome Sequencing; and TGen is looking into potential anti-viral and antibody drug treatments, and vaccines. We are also developing a serological test, a blood-plasma test, which looks for COVID-19 antibodies, and can thereby identify individuals who have been exposed to the virus and have potentially built up an immunity, at least to the current strains.

IS TGEN NORTH A TESTING SITE?

Yes, we are a clinical diagnostic lab that is providing testing for a number of entities, particularly in the Northern Region. Coconino County Health and Human Services (CCHHS) partnered early with us in response to COVID-19, and together we established the first drive-through site established in Arizona. We’re also working with North Country Health Care, Northern Arizona Healthcare; Mt. View Pediatrics; the Coconino County Medical Examiner’s office; Northern Arizona University; and the Guidance Center.

DO YOU NEED A DOCTOR'S REFERRAL TO RECEIVE TESTING?

Yes. Those who are potentially infected by COVID-19 must receive a doctor’s referral to be tested; keeping those with potential infection out of doctor’s waiting rooms, and out of emergency rooms, where they could infect others.

HOW DOES THE TGEN COVID-19 TEST WORK?

TGen’s diagnostic test is similar to the CDC test in that it looks for a particular genetic marker that indicates the presence of virus in a patient’s sample. Unlike the CDC test, which only looks at one gene, the TGen test has improved robustness as it looks for markers in two genes.

HOW RELIABLE IS THE TEST?

Our test, which is based on our own genomic characterizations of COVID-19, and has been revalidated against the global knowledgebase of the virus and its genome, is considered highly accurate. It is highly sensitive in that it can detect less than 10 viral particles in a patient sample (most samples have millions of viruses), and has been shown to have 100% specificity against all known human viruses.

IN ADDITION TO TESTING, YOU’RE ALSO TRACKING THE VIRUS IN ARIZONA. HOW IS THAT HELPING?

Tracking allows us to gather data; to better understand where the virus comes from, how it mutates or changes, and how it moves around. And that's important for us to understand as this pandemic moves forward. The more data we have the clearer the picture becomes, which then allows us to see changes sooner and in turn makes it easier for public health officials to step in and, hopefully, address the problems as they arise more swiftly and accurately.

WHAT IS THE EPIDEMIOLOGY TELLING US THUS FAR? AND HOW DOES THAT PLAY INTO DECISIONS STATES ARE MAKING ON WHETHER TO OPEN, AND IF SO, HOW BROADLY TO OPEN.

We’re seeing that this virus definitely has a different epidemiology, depending upon where it's at, by which I mean what part of the country or region. That means how the virus spreads and what are the right precautions that need to be put into place are going to be factors in making those types of decisions. For example, if you live in New York, where there are millions of people in a relatively small geographical area as compared to Arizona, where our population is a bit more spread out, you may choose to open more slowly and keep certain precautions in place longer.

WE HEAR A LOT ABOUT VACCINES BEING DEVELOPED. WHAT CAN YOU TELL US ABOUT THAT?

Even though we don't have vaccines available yet, there is an enormous amount of work being done in the research and development space and I expect we’ll see more than one or two vaccines come out of all this work. Equally important is the tremendous amount of planning and development going on around the world in terms of vaccine distribution. The Centers for Disease Control and Prevention is leading this, but also The WHO, and a number of international health organizations, working on how to provide the vaccine first to those who need it most, and then to the larger population. .

WHAT LESSONS HAVE WE LEARNED FROM THIS PANDEMIC, AND HOW DO THEY PREPARE US FOR PERHAPS A SECOND WAVE IN THE FALL OR ANOTHER VIRUS IN THE FUTURE

One lesson we’ve learned is that it’s imperative that we use the best of science and technology available to not only understand and treat the disease, but to also develop ways to detect outbreaks faster and in places we don’t expect such events to occur. A second lesson I believe we’ve learned is that it’s important for the regulatory process to keep up with the pace of any potential outbreak. I think we’ve learned that the regulatory steps are necessary in order to provide benefit for health and safety, but having a better control of the gas pedal and brake allows for certain restrictions to be eased to accommodate a more rapid and precise response.

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