Jesse VanWestrienen: Co-Founder & Biology Lead at Biomeme (Raise the Line)
Hey guys, I'm Dr Aai from osmosis. I'm the Chief medical officer.
I'm here today with Jesse Van Ween, who is the co founder of Biomems. He's a virologist, a molecular biologist as well and actually worked on COV one, the virus that actually preceded COV two.
So we're here with him today. Thank you so much for being with us here today, Jesse.
Hey, thank you for giving us the opportunity to it with you today, Jesse, can you get into Omim the role of the company, what you guys do and also how this test works and where it might work?
Sure. So at Omim, we develop uh a, a series of tools that allows anyone to isolate nucleic acids or DNA.
Um to we design tests to detect DNA from those samples. We make hardware that allows anyone to amplify that DNA and uh our hardware systems communicate off of a smartphone app.
Um So what Omim is about is um enabling anybody anywhere to detect DNA in short. Um And really what it's about is providing information from DNA.
Uh so that stakeholders can use that information in the case of a diagnostic for human health um that can guide treatment options.
Right. Um So by, I mean, we've been around for about seven years and uh we had a variety of different use cases we've been working on um before this COVID-19 outbreak.
Um A lot of the customers that we had or anyone from the US government um who is looking at environmental surveillance. Um We have a wide variety of researchers that do field work where they want to detect DNA in the field.
We've been working with some industry partners around um manufacturing and industrial quality control. Um So it, it really runs the gamut of, of use cases and industries.
Um And uh there's many more applications that are, that are like that since the uh COVID-19 outbreak. However, uh we've been inundated with requests um for people looking for testing solutions.
Um And that includes the US government and uh and hospital systems um and, and others. Um And so really, it's gonna be our main focus for the next I'd say 3 to 6 months, certainly as we work to scale our manufacturing to provide those testing solutions, I'm gonna give a brief demonstration of, of our products uh for your users.
And I hope that um it'll make a little more sense for everyone here. Uh So our platform includes a consumable sample prep product.
So this is a one off use um sample prep cartridge. It contains all the chemistry and buffer necessary to isolate DNA and RNA from a variety of sample types.
Um We developed this cartridge here with a foil seal on top and also this sample prep column, it interfaces with a 1 mL syringe and essentially the way it works is a user simply would perforate the foil and they would add a, a sample to it.
Um In the case of SARS COV two, that sample could be something like a nasal swab, nasopharyngeal swab or an oral swab. Um Once that swab sample is placed into the transport buffer, it's added into that sample.
Well, right there, that sample well contains a license buffer. So what it's doing is it's um breaking apart all the cellular material um and freeing the DNA or RNA.
Um the sample material that's in this column is a membrane that will actually bind the DNA um from the sample but leave all the other material uh I in the in the liquid there.
And so really the way you bind after adding your sample is simply pumping up and down. So we've designed our sample prep so that um again, really anybody can do it, it doesn't require any other lab equipment or specialized uh training.
So I've been binding my nucleic acids to the column here. And next step is to simply move over into a wash buffer.
So many of these sample types have a lot of different um gunk or junk in there. Um And you need to wash them to remove any of that gunk on the filter.
It's followed by another wash. This is actually a salt wash.
So it's washing the membrane of the salts that were used to purify your sample. We have a drying wash and that's followed by an air dry step.
So now we're removing any residual buffers from that membrane. And the last step here is an illusion.
So the DNA that was stuck on the membrane is now gonna come off the membrane and your purified DNA or RNA is now in solution there.
So that's it. As you can see, it just takes a couple of minutes.
Um If you're not talking to explain it, it's even faster. And now this last, well, there has your pure DNA or RNA.
So really the next step in the process are the free stride PCR assays themselves. Um What that is is a real time PCR assay that is uh contains all these specific um targets that will identify whatever test you're interested in.
Um So in the case of SARS COV two, these assays actually detect two different gene targets of the SARS COV two genome and um and extraction control target.
So the way you work, this is you simply remove that foil, you then are gonna add some of your sample into the well, and I'll just do all three here, you cap it and then it goes in the hardware itself.
This is our Franklin real time. PCR thermal cycler.
It's a uh nine well uh PCR thermal cycler. What that means is um you actually are using light to detect uh your various DNA or RNA targets.
Um The hardware itself is communicates via a smartphone app. So we have our Omim go up here.
Um This can communicate to the hardware device via Bluetooth. Um And the way that works is you simply start run.
You're gonna scan a QR code on that test pouch. I showed you earlier, you're gonna confirm your test, you can scan aid a sample id and then you will save your result, hit, confirm and it's gonna walk you through how to power on the device and get the test running.
So as you can see that also takes um only just a couple of minutes and, and then you have your test running. That's incredible.
How, how did you guys get this together in just a few weeks? I'm so impressed.
Yeah. Um The initial design work is pretty quick these days.
Um You know, they release sequence from China very early on. Uh it's publicly available.
Um And there's tools these days that make it um quite, quite quick, um very powerful computer tools to do your in silico analysis, etcetera.
Um So the initial design uh really took a few days. Um And then nowadays getting DNA synthesized is also very cheap.
So the particular um markers that are in the test can be synthesized within a week. Uh You can also synthesize short strands of DNA from that sequence.
You can pull any sequence from a computer and have it synthesized. Um That allows you to use um what really to do development of these tests without any actual genomic or viral material, which was uh much harder to get uh hands on at least early on.
Um So the whole test took a couple of weeks, but the verification and validation that takes a little more time and this looks like you're using isothermal technology rather than a thermocycler.
Is that accurate? No, it is APCR thermal cycler.
So other groups that have isothermal applications uh could run them on our system. What are the big advantages that this process has over other current testing options?
Yeah, I'd say the biggest advantage is distributed and fast. So as you can see, everything's really the size of the palm of your hand.
It can be carried anywhere. Um It has an internal battery so it can, it can perform around six tests per battery charge.
The consumables. As I showed, you are also very user friendly, don't require any uh extra lab equipment.
So um you really can perform these molecular grade um sort of lab standard tests um very quickly. And do you mind saying how quickly?
So how long does it take for one sample, let's say to get processed. Yeah, for one sample.
So the sample prep process takes a couple of minutes, loading the test another couple of minutes and then about 45 minutes for the thermal cycler to run.
So, you know, all in all you're getting a sample done in about one hour. If you wanted to run multiple samples, it would add an additional 15 to 20 minutes on that.
And how many samples could you run concurrently if you wanted to using this process? You could, yeah, you could run um up to nine samples concurrently on this Thermocycler and, and if you did do batches of nine, then it, it sounds like it would take maybe an hour and 20 or, or something all in.
Yeah, it would probably take about 30 minutes to do the nine sample preps. Um and the loading them into the device and app is, is just a couple more minutes.
Um and then the device running. So instead of an hour, it'd probably be about an hour and a half.
Got it. And you, you submitted this for FDA for review.
When are you hearing back from them? Yeah, so we submitted the test for FDA um eu a authorization.
Um It was first submitted by a clinical lab called One Health Labs um who used our products to develop an L DTA laboratory developed test and then submitted that to the FDA.
Um Biome has gone ahead and also submitted um or we will be submitting uh tomorrow actually um a protocol in end end protocol.
Um really the use case that we wanna go after is more point of need there. Um So again, as I mentioned that that more distributed use case.
And so uh the initial submission is from data collected in the lab. Um but we hope to amend the file um and work with the FDA to, to demonstrate feasibility in a distributed um If this does get government approval, which obviously everyone is kind of collectively hoping more and more tests are available on the market like this one, how quickly could you ramp up production of this?
So if we get FDA eu A approval, um we've been working to ramp our manufacturing and, and scale that such that we can deliver as many tests as possible where they're needed.
Um To do that, we've already initiated uh manufacturing of a second assembly line of our sample prep products. And um we've been working um with our manufacturers on the freeze drying side to also scale that.
Um I think that that work will be done in probably 1 to 2 months to really get to that sufficient scale. Um where we hope to be able to supply thousands of these tests weekly.
Can you speak just briefly to the role of testing in general? How important it is to fight COVID-19?
Yeah, I think testing is critical to fight COVID-19, I think that the lack of testing early on um really caused a lot of problems.
People didn't know where the virus was, how much of it, what there was and it really has led to an acceleration in the number of cases.
Um You look at places like South Korea that implemented very good testing very early on. Um They've been able to flatten the curve better than we have so far.
Um And so I think going forward as we slowly fall from the extreme social distancing and um current lockdown measures, I think the testing will be critical to keeping the virus at bay really understanding where it's at, who has it and most importantly, um track and trace individuals that may have been exposed, test them such that you can isolate.
And um I think that will be how the world will um slowly try to get back to some normalcy. Um You know, from here, Jesse, can you get a little bit into where these devices and products would be best fit, where are they going to be used in terms of like homes or clinics or hospitals in the US or abroad, any of those kinds of topics?
Yes. So that really depends on the application or the use case um for research or research use as well as uh some of these other applications I mentioned like uh industrial quality control, the tests are performed um really anywhere they they can be on site, the back of a truck, um a small sort of work office or a small lab.
So that's like you can think of that as central labs, um uh labs within hospitals, that sort of thing. Um We also hope to be generating some end to end test data of farther forward or distributed test settings.
So small test um pop up test sites. Uh You can think of like um you've seen the drive through collection sites.
Um We see no reason that we couldn't, people couldn't be using our products right there on site to provide a fast turnaround.
One related question, Jesse that just came up from this, you said it could be done anywhere including the back of a truck.
That's a pretty powerful visual who can do the test. So for example, do you need certain training?
Can a can a patient do it themselves that may seem obvious? But um or do you need to be a clinician or do you need to have some sort of lab credential to be able to pull this off?
I would say that really anybody with training can do that. I feel confident that I can demonstrate to a user um more or less what I showed you um and get them comfortable with, with the procedure.
Um and then practice helps. Right.
So after a few times of them doing it, it, it really is pretty simple. Um In terms of the COVID-19 testing, I'd see the first users being people with a little more experience.
So this could be um lab technicians, medical technicians, nurses, um those sort of users. Um We're not, uh it's really not in a place or approved for home use yet.
Um So you won't see the initial products in the home. Um But one day that's where we wanna go and uh and that'll be even more powerful when we get there.
Well, II, to be honest, I went this whole interview and didn't realize that that was your overall vision. That's actually pretty incredible.
Thanks for sharing that. Yeah, no problem.
Can you speak to the sensitivity and specificity of the test and how it might differ from other tests that are out there at the moment for our T PCR?
Yeah. Um So our test uh is quite sensitive.
Um the LD that we submitted to the EU A uh that data package had us at 1.8 RNA genome equivalent per microliter. Um So as, as you can see, that's right in line with uh many of the other eua assays molecular tests that are out there.
The CDC, for example, um in terms of specificity, we tested the test in the lab against influenza A influenza B RSV. Um obviously other common circulating respiratory organisms.
Um We also did a full in silico analysis, which is what the FDA requires where you look to publicly available databases to see if there's any predictions around cross reactivity.
And, and we were happy to report that we didn't detect any significant um cross reactions with a wide array of other organisms that we couldn't test in the lab.
That's awesome. Do you have any public sensitivity or specificity percentage?
Uh For example, an NP swab, we also were able to get our products to a group in New York called North Well Health. Um They're one of the largest uh hospital providers in, in New York.
Um One of their uh lab directors and uh their team who do a lot of the lab testing has reached out looking for those distributed diagnostics.
Um They did an initial evaluation uh with our end end test against um samples that had already been um either determined positive or negative with other FDA eu A um methods and uh we found a um 98% sensitivity.
So we missed uh there was one discordant result um out of, I believe it was 42. So um we're pretty, very pleased with that.
Uh It, it seems that it'll match most of the other EU A uh systems are out there. I know that's a sort of small study for now, but it's with actual COVID-19 samples um from NP swab.
So, uh it was a, a very good demonstration of a capability. What's your message for providers right now?
Oh, man. Um, keep doing what you're doing.
You're, you're uh critical. Um II think one of the best things that's come out of this is people really realizing uh and appreciating the healthcare workers out there, right?
Um, who are, are working their butts off to make sure that as many of us stay healthy. Um And so I hope that that's one of the long term lasting um things that come out of this whole mess is a better appreciation for not only healthcare workers but public health in general.
And then more broadly, what do you think can or should be done overall to raise the line? In other words, to expand the capacity of our health care system.
I mean, that's a tough one. II think that in our case, testing is critical um not only companies like ourselves, but there's many, many others out there that are all working to provide as much testing solutions as we can.
And it's gonna take the combined approach of, of really everyone in the entire industry um to do that. So II guess from my perspective, yeah, being more immersed in the on the testing side of things.
Um that, that's where I see uh how we can help Jessie. It's been a pleasure chatting with you.
I'm pretty uh impressed with what bio means doing. I think our audience is gonna be pretty wild by what you just had to say.
Thanks for doing it. I'm Doctor Wei with osmosis.
Remember to do your part to flatten the curve and raise the line. Remember we're all in this together.
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