Lori Walsh: Since the coronavirus pandemic began, testing has been key to slow the spread of Covid-19. It's also become a key to a certain peace of mind for South Dakotans. Today we're talking about coronavirus testing done in-house at Avera, and how that health system was poised to respond to the need because of existing infrastructure and expertise. My guests for this segment, Gareth Davis, he's chief scientific officer at the Avera Institute for Human Genetics. Welcome Gareth. Thanks for being here.
Gareth Davis: Thank you so much. It's a pleasure to be on the show again. I'm usually on here talking to Kara and telling her about the exciting research we'll be doing, but I'll hopefully give you a different story today.
Lori Walsh: Yes, and Dr. Michelle Bleile, Medical Director for the Avera Institute for Human Genetics. Dr Bleile welcome as well.
Dr. Michelle Bleile: Thanks Lori, it's a pleasure to be here.
Lori Walsh: Gareth, I want to start with you because so much has been made about healthcare infrastructure and preparedness from an emergency room standpoint, but this conversation we're having today is really about being set up to make this great leap into Covid-19 testing at the Avera lab. Tell us a little bit about that process and how it has unfolded.
Gareth Davis: Well, it's a really wonderful story to be honest. We began this only about 10 days ago, and almost started from scratch as far as infrastructure was concerned, as far as physically in the lab. The Avera Institute for Human Genetics is predominantly a research laboratory, although we also do pharmacogenetic testing on patients, but research was our number one focus.
That research really set us up to be able to do the highly technical and precise work that testing involves. But we really had to rearrange the lab in a major way, and involve a wonderful team of people that has helped us along the way to get to a position where we can accurately and safely test for Covid-19. This has involved a team effort of extraordinary... It really is amazing. I mean, we literally had architects, construction workers, the main lab who have been amazing. Dr. Bleile who is here, to get our lab up and running and to validate that with the state lab, Dr. Tim Southern at the state lab in Pierre was integral in that too. It's really been a roller coaster ride to get this ready for our people in South Dakota. But we were very well prepared with the techniques and expertise that we had, and the infrastructure. But literally the physical change to the lab has been really remarkable to see.
Lori Walsh: And we just talked with Eddie Sullivan from SAB Therapeutics again, talking about that team of scientists and it got a little emotional, Dr. Bleile, listening to Gareth and listening to Eddie, just the... I know you're not going to like the word heroic, so I'm going to say monumental and hyper dedicated efforts for people to, to work toward everything in their power to alleviate the suffering for people. Dr. Bleile, tell us a little bit about how this lab will work, and as it goes into operation, the number of tests and how those tests are going to be processed. Give us an outline of how that lab operates please.
Dr. Michelle Bleile: Sure. We're fortunate to have had CLIA and CAP certification already in place for our pharmacogenomic testing. It was a good setup to utilize the expertise of the scientists here to develop this test, and under the guidance of CLIA and CAP so that we could do patient sample testing and resulting. We had to go through scrutiny from the state laboratory, as Gareth mentioned, rapidly because the FDA allowed the state, and this is happening all over the country, to analyze our ability to do the testing, and give us the go ahead on behalf of the FDA. That's been a wonderful team effort. As Gareth said, this entire thing has been amazing to witness an entire team of people with different skill sets come together to make this happen for our patients in our region.
So you asked about numbers.
Lori Walsh: Yeah. How does it change the game as far as testing?
Dr. Michelle Bleile: Sure. There are hundreds of collections of samples a day, and we are a small part of a system that's in place right now that specimens go to the state for testing to commercial laboratories, including Mayo. And then we can assist with that as well. So for the near region, the Avera region, we are taking the tier one specimens, which means the patients meet very high criteria. They're inpatients, they are very ill, they have comorbidities. Those ones are set aside for us to test, and the rest go to Mayo so that we're not slowing anyone down. But that the most critical patients can get their results as fast as possible by doing the testing here on site. At this point we're doing up to a hundred a day, hoping to ramp up soon.
Lori Walsh: And we've heard, just for clarity for listeners that those positive tests are all being reported to the State Department of Health. So they are included in that daily count that we're getting from governor Kristi Noem, secretary Kim Malsam-Rysdon. I understand that correctly, right? All the positive tests in the labs. Are the negative tests from Avera's lab also being reported to the state? How does that work?
Dr. Michelle Bleile: Initially the requirement was to only report positives, but now all the numbers, positive and negatives are reported for daily tracking across the region, and state.
Lori Walsh: Gareth, one of the things that this feeds into, and I'm sure you understand the larger context of this is how urgent the need has felt for increased testing. Not only for people if they have a negative test, to know that they're not contagious to their loved ones at home, but we're still prioritizing testing at some point as I understand it. What do you know about how the creation of this lab, and the increase in numbers, how is it going to change the data collection for Covid-19 in order to help stop the spread? Is that part of what's shifting here?
Gareth Davis: Well, I think Dr. Bleile is much more experienced, and has a better expertise than mine in this area really. But we are able to, as she said, the severely ill people who have comorbidities, we're able to speed that up. We're also able to help our own physicians and the healthcare workers, who are actually tending to the people who are sick, or potentially sick. And we help with the screening for those. I believe any help with the numbers that are waiting to be tested is something. Hopefully we'll ramp things up even more now in the next coming days and weeks.
We literally began on Sunday when we got the all clear from Dr. Southern at State Labs. I believe that this is going to make a big difference. It prioritizes certain people who are very sick, who were maybe in the ICU, and then also helps the healthcare providers to know if they have contracted the virus, and whether they should be isolated.
Lori Walsh: Dr Bleile as a pathologist, you deal with the complexities of this testing, and bouncing off of what Gareth just said, I've been pretty open about my family's journey. My brother has cancer is already presented at the emergency room. He lives in Minnesota, and has had a test. Every one of those tests that you do, and the work that these scientists have done represent a loved one. Like my brother, a person who we've been working so hard to keep alive for so many years, and we were able to get his Covid test back very quickly. It was negative, and then they tested him again because of some of the cancer treatment that he's had. Talk to us a little bit about how accurate, are there false positives or false negatives? What do we know about the complexity of the testing, Dr. Bleile that illustrates to people really how complicated this is.
Dr. Michelle Bleile: I think that the biggest issue is it can go to address the people who are asymptomatic and want to be tested, that you can get a false negative if someone has a very, very low viral load. That's why at this point it's only encouraged to test people with symptoms, or significant comorbidities, for that reason.
Lori Walsh: People have also been asking, Dr. Bleile about how long samples are able to wait for the testing, if they stay good. Some people have gotten a test, and have waited six days for the results. And their question is, "Is my sample even good anymore?" Walk people through that a little bit to help help provide them with some scientific information to declare the air regarding that.
Dr. Michelle Bleile: Sure. I think it depends on what you mean by is it good anymore. The sample is very stable, and so the answer or the result will be correct. But what have they done between the time of their sample collection, and now have they been exposed? That would be the issue.
Gareth Davis: Yeah, there's sample, once it's collected, literally the swab or whatever you want to call that, once it's collected, it's frozen at a very, very low temperature, minus 70 degrees centigrade, and then kept at that. The sample is very, as we say in science, stable at that time. This virus is known as an RNA virus. There's RNA inside it, instead of DNA, it's RNA. And it's very unstable at normal temperatures. So once you've extracted it, you have to keep it at very, very low temperature. Prior to testing, it's very stable. And when we can keep that, and it's relevant to test. However, post test, things start... Re-testing a sample sometimes can be problematic.
Lori Walsh: Right. Anything else that you want to add about... First of all, congratulations on this validation, and thank you for the work that you're doing on behalf of everybody. Really, thank you for the service, and the sacrifice that your families are making, and from the construction workers, to the scientists, to everyone in between. Gareth, have you kept everyone safe in those circumstances as well and protected as you move forward quickly, but you also need to protect the workers?
Gareth Davis: That's been our number one concern. First of all, to bring the test into the laboratory was my number one question was how do we keep people safe? I'm really fortunate to have a wonderful team here, and a wonderful team at Avera that came along. As I said, the architects, the construction people, and they were so reassuring. They've done this type of thing before for other diseases that have come up, TB and the things at the hospital. They confidently built an isolation area within our laboratory. And our staff wear breathing apparatus when they're dealing with the live virus, and protective clothing obviously.
I'm as confident as I can be that they're safe, as I can guarantee them to be. It's a big ask to ask someone to go and do this test. I mean, it does bring some fear of contracting the virus themselves. I have the utmost pride and respect for the people who are actually in there extracting the RNA, and doing the amplification to get the test results. These people have made an incredible effort, and they're very tired. We are getting extra help now, but they're doing an amazing job, and I thank them with all my heart that for what they're doing.
Lori Walsh: And thank you so much. I'm going to use the word heroic because I can. So Gareth Davis is the Chief Scientific Officer at the Avera Institute for Human Genetics. Thank you, Gareth. We appreciate your time.
Gareth Davis: Thank you so much.
Lori Walsh: Dr Michelle Bleile is medical director for the Avera Institute for Human Genetics. Thank you so much Dr. Bleile. We appreciate it.
Dr. Michelle Bleile: Thank you.