Developing diagnostic tests with and for the United States military is rewarding but not without its challenges. The process is unique and generally takes much more time than developing products for the commercial clinical market.

For diagnostics manufacturers, entering into a contract with the military can be very lucrative and worthwhile; however, it is not for the faint of heart. From initial discussions to production of the final product, the process is very involved and can take years.

To learn more about what a diagnostic company can expect when forging a relationship with the military or with local first-responder teams, IVD Technology editor Richard Park spoke with Matt Scullion, business development director at Idaho Technology, a pathogen identification and DNA analysis company (Salt Lake City). In this interview, Scullion talks about the peculiarities of working with the U.S. military, Idaho Technology’s experiences in the nonclinical diagnostics arena, and the evolution of the real-time PCR platform.

IVD Technology: How did Idaho Technology first get involved with working in the area of nonclinical diagnostics and developing technologies for the biodefense military testing market?

Matt Scullion: We started a small biotech company. It was a bootstrap company, and it was a spinoff from the University of Utah. This was back in the early 90s; we’re actually in our twentieth year now.

It was very-high-speed PCR that evolved into the LightCycler technology. The military had bought some of the high-speed PCR machines that became real-time PCR machines, and they liked them a lot. The military came to us and said, these are great and all, but when we strap into planes and want to take the machines into these kind of rough environments and bounce them around and transport them all over, they rattle to pieces.

So they asked us to make a rugged version of our LightCycler. This occurred in the mid- to late 90s and with a small amount of money from the U.S. Air Force. We launched a military-specific real-time thermal cycler based on our LightCycler technology.

Does Idaho Technology have a relatively longstanding relationship with the U.S. military in terms of developing various testing technologies?

Yes. When the military develops a product on its own, it’s an extremely long process. The development cycle can usually take somewhere from 7 to 10 years. It’s all part of the long acquisition process that the military has. It’s very involved, and it can take years writing specifications and documents and going through the initial testing and evaluation, down to selecting the companies that have potentially useful technologies. Then they send out requests for information, and they keep narrowing their list down until they come to a company or number of companies that can provide them the products that they need, or products close to what they need.

They can award the contract to one or two companies, and those firms develop products to meet the military specifications. Then, finally, after a long, long process, they get to the actual production. That’s quite a long process and it’s a bit different from your standard commercial process where you go and ask the market what they want, or you do research into what the market needs and build around those needs, and then use traditional sales channels to move your products. The military is two-sided. They want the products that they want in terms of rugged military-type devices, but they also need clinical diagnostics just like any hospital in the United States.

The military has more than 3 million troops out there that they need to keep healthy, and it’s not all military hardware that they’re keeping them healthy with—it’s mostly standard, commercial, off-the-shelf products that they buy.

There is not a very big commercial market for biodefense or biowarfare technology, so the military actually sends out the specifications for what they want and they ask companies to build to those. We happen to have some unique products that fit into what they wanted to do, and we competed for the contracts that we have. And we’ve been very successful there, but it’s also a very niche market spot.

How exactly did the military contact Idaho Technology?

Are the biodefense and military testing technologies that Idaho Technology is working on adopted from other previously developed technologies? If so, how did Idaho Technology adopt the technologies to be used for biodefense military testing purposes?

They all stemmed from previous technologies, more or less. Real-time PCR, the LightCycler—that’s where our original technology for the military stemmed from. Later on, as the technology has changed and evolved, the military likes to make things extremely easy to use and very simple.

Much of the evolution of these products—this goes for most lab products in general—start out in the lab and then become automated and much simpler to use. The military wants the same thing, but it also relies on existing technology that’s available.

In the late 90s, there was real-time PCR, and you still needed to be a lab technician to use it, but we did make some military-specific adjustments to our lab kit that made it easier for them to use. But it was still a lab kit that required a lab technician.

As these things have progressed, and the military has seen where the technology is going, they’ve requested that we make simpler systems that are easier for soldiers to use. So we developed a real-time PCR platform called the Razor for first responders and special forces.

They don’t need to be lab techs. They don’t need to do a lot of sample manipulation. They simply take a sample with a syringe, pop it into a cartridge, and the cartridge pulls in the sample and automatically does the analysis for them.

That’s kind of the direction we’re going in with most of our technologies in general. It’s ease of use, less human interaction. But from the beginning, it’s all usually technologies that are already in existence. We just adopted them over to the military’s needs, which are ruggedness and the ability to target and identify bugs that aren’t very common and are more specific to biowarfare.

How do you go about making military-specific adjustments?

Military personnel have to take their instruments into some pretty rugged environments over which you don’t always have temperature control or humidity control. You can’t always control having a roof over your head. You may not necessarily have power. They’re faced with logistics challenges that you don’t have in a standard lab.

On top of all that, they move their equipment around frequently so it’s got to be able to be dropped and handle vibration. If the device is being used on a ship, for example, it must be able to run with some vibration and rocking. The military has some pretty long documents with miles and miles of specifications.

How do you go about making the equipment simpler to use for military personnel?

They actually have training programs for lab technicians in the military, and each branch has medical technicians for the medical labs. But you also have these forward-operating bases and much more rugged areas where this equipment is deployed, and some of these medics and other folks don’t have a high level of lab training.

We do have to make these things simpler and simpler. The military is also very rigorous about their training and giving equipment to people with the requisite training. So the simpler you can make these systems, the easier it is for the military to train their personnel, and the easier it is to use.

When it comes to biowarfare detection, it’s not something they do everyday. So the systems have to be simple enough or self-guiding enough that someone can pick it up after not using it for six months or a year, and be able to turn it on and run a test.

It’s a difficult job of doing what they call “soldier proofing” these systems to make them simple, rugged, and easy to use.

What exactly is the process involved in developing biodefense military diagnostics? Do you as a company identify specific pathogens and develop completely new technologies for those agents, or do you adopt current technologies to detect those specific agents?

What are the primary challenges involved in developing biodefense military diagnostics, and how do IVD companies overcome these challenges? You just mentioned finding samples. Is finding proper and sufficient samples one of the main challenges?

Yes, absolutely. For some of these diseases, they occur so infrequently that you’ve got to design special trials around them and move to spiking samples or animal models to complete the trials. You also have to go to specialized facilities. You need biosafety laboratories that can handle anthrax and some of these other bad pathogens and have the clearances to do it.

Some of these bugs are controlled in terms of who’s allowed to handle them and even have them in their stocks. But the facilities and people that you need to do these tests are pretty specialized people and you don’t have them everywhere. So you have to go places like the Army or the Air Force to get these tested on their special biosafety level 3 and 4 facilities. That’s a huge challenge. Finding real clinical samples of people who have these rare diseases and are presenting with anthrax or plague is another huge challenge. So designing a clinical trial around such small numbers, or artificially spiking these things, is a challenge.

It is something you have got to work hand in hand with FDA to work through, to figure out how you can create and make a trial that’s representative of what you’d expect to see in the real world if one of these things were intentionally released and you had to actually use these for future diagnostic purposes.

I presume the military is fairly willing to provide you with hard-to-find samples. But what about nonmilitary sources of such samples? How open are they to providing and sharing samples for your R&D purposes?

Most people are pretty receptive to it since this is often work that’s sponsored by the military. We go through military labs often. Other times we go to foreign countries that might have a prevalence of Q fever or one of these other exotic diseases or pathogens. If there is a certain rate of them within the country, then we can find clinical isolates that occur frequently during the year.

Some of our clinical trials actually happen outside of the United States. But, especially for these military systems, we always work in conjunction with the U.S. government because they are often sponsoring the development and clearance of these tests. It’s still a challenge, though. Most folks who work with these pathogens are, on a day-to-day basis, generally research types, or they are researchers connected to some clinical facility.

But because these trials don’t happen frequently, they are often very eager to help us with doing that clinical and future diagnostic test for some of these “orphan” pathogens because they just aren’t very frequently seen.

You mentioned working with FDA, and I presume it has something to do with devising clinical trials. Is such a collaboration truly necessary, since the devices that Idaho Technology is developing are primarily for military purposes and the company is under military contract to develop them? Or is it because the plan is to eventually commercialize these products outside of the military sphere and make them available to others, such as first responders—police departments, fire departments, and others?

We are currently developing many more commercially tracked IVD products in our film-array systems for respiratory disease panels and sepsis panels. We have a wing of our company that’s dedicated now to developing IVD-commercial-specific products.

In terms of the military products, we have permission to share them with U.S. federal government agencies. So outside the DOD, U.S. federal government agencies are allowed to purchase these IVDs for use in events such as the anthrax attacks of 2001. So it is open for use to first responders and public health for doing IVDs if they need the kits.

Prior to 1991 and Gulf War Syndrome, I think the military took a turn in their own policy and went the route of wanting to have all their clinical diagnostics as well as their therapeutics, like vaccines—anthrax vaccine and the other vaccines that they’re developing for these exotic agents—to be FDA-cleared.

I think they found that it’s just not acceptable to use experimental technology or “for research use only” techniques on troops just because they’re in the military. So they had a bit of a policy change in the mid 90s, but it has shifted everything that is clinical in use or used on troops for healthcare or diagnostics. Be it biowarfare or day-to-day use, it is all FDA cleared.

I think the idea that the military gets a so-called “free pass” is an old philosophy that is still lingering a little bit, but in fact, our JBAIDS (Joint Biologic Agent Identification and Diagnostic System) instrument was the first FDA-cleared military device that they’d ever done in in vitro diagnostics. So we may have helped them turn that corner, but I believe they had that policy change in the mid-90s to make sure that they weren’t doing experiments on soldiers anymore.

Have biodefense military diagnostics been developed for all the major pathogens, and which agents are Idaho Technology and other IVD companies still working on and developing diagnostics for?

Not all of those pathogens have diagnostics built around them. Some of them require PMAs—premarket authorization—which is a little more expensive and much more difficult to get through FDA.

Some of the other pathogens, such as smallpox, are just so difficult to get a hold of that the thought of doing an FDA clearance is a little bit daunting. So we have a short subset of what we do have cleared. They are much more accepted, traditional biowarfare pathogens that have a higher rate of natural occurrence—things like Q Fever.

We’re going through clinical trials now, and I believe we have a couple more slated, but they’re also finding some emerging infectious diseases that are also a big concern to the military, such as influenza and the swine flu. So we’ve been taking the CDC assays and transferring them over to military platforms and doing the bridging studies and getting FDA clearance to use them on our platform.

There is a list of important biowarfare pathgoens we have developed environmental tests to detect. We examine that list and prioritize our FDA clearance efforts using multiple criteria including what is possible to get through FDA without doing a PMA.

From what you know and understand, what sort of effort is the military trying to make to determine what other bugs or pathogens that are out there could be weaponized? How are they engaging companies like Idaho Technology to stay on top of it and develop technologies for testing purposes?

That’s an interesting and somewhat complicated question. The government as a whole has a policy on how to deal with emerging infectious diseases and enhanced and modified pathogens.

With emerging infectious diseases, such as SARS, for example, sequencing came in as a key technology to identify what the pathogen was in the first place. Type it out, and then you can develop in vitro diagnostic tests once you have sequenced it.

Rapid sequencing is useful and powerful in identifying emerging infectious disease, but it is not fast enough or cost-effective enough for day-to-day in vitro diagnostics They aid in identification of these modified and genetically engineered bugs or bugs that have been engineered to be resistant to such therapeutics as antibiotics.

But it’s a difficult challenge, and they certainly have infrastructure in place to deal with that, but the intelligence community gathers data from their sources. You know they collect samples and isolates from all over the world to archive and get a database for sequence information. Then anything new that might pop up—they’ve got great tools these days for sequencing new pathogens very, very quickly.

That trickles down to a company like us that designs, tests, and can quickly turn around and manufacture products and get them through FDA as fast as possible. Even FDA has mechanisms for emergency-use authorization for emerging infectious disease like what we saw with the swine flu.

There’ve been a number of tests that have gone through FDA clearance for emergency use authorization very, very quickly. So there are mechanisms in place to deal with these things. They’re never ideal. Nothing happens overnight, but the process has gotten quite good and quite fast, and the infrastructure is there to deal with this as a much more high-level public health response rather than local researchers doing their own little research-use or home-brew tests anymore.

Looking toward the future, what efforts will Idaho Technology continue to make in order to develop biodefense military diagnostics that are better and faster? Furthermore, do the military’s demanding specifications include rapid testing as well?

The military definitely has a different view of nonclinical tests. They’re more environmental tests. They want to know if something has been released in the environment or if the troops have been exposed to something.

The faster they know, the faster they can treat them. You can’t wait 2 or 3 days for a culture to come back before you start treating someone. By that time, it may be too late to actually get effective treatment before the pathogen will kill them.

Developing these rapid diagnostics as well as environmental tests is pretty important for the military. The quick turnaround is also important because they have detectors out there that will alarm when they see a biologic cloud or something unusual blowing through the air—in which case, the troops will put on their protective gear and will stay in it until someone can test one of the air samples and say that it is a false alarm. The faster you can get those troops out of that hot, cumbersome, protective gear, the better the troops are going to do their jobs.

The military does have specific requirements because they work in environments and conditions that we don’t see typically in the United States’ civilian society. They give us specifications for developing systems and turnaround time. Historically, the desire for turnaround of real-time PCR assay for the Department of Defense is 30 minutes. We in turn aim to design systems that will meet that target. On our new, more-automated systems, we incorporate sample prep and all the multilevel PCR and run analysis. It’s all done in less than an hour, and we’re even trying to push that to get closer to that 30-minute mark that we like.

Is Idaho Technology involved in developing technologies for other areas in nonclinical testing, such as agriculture, food, environmental, et cetera? How does Idaho Technology parlay its biodefense military technologies and experiences into developing other nonclinical or even clinical diagnostic technologies?

We have an entire food testing division, so we leverage our high-speed, easy-to-use test formats to test for things like salmonella and E. coli and Listeria, and various food matrices.

The food testing market has its own regulatory agencies and its own challenges with all different types of foods, but we draw on our military testing background experience. The commercial sector also wants things that are easy to use. They want things that are very robust, and if they move a machine around, they don’t want to have to recalibrate it and go through all of the standard steps that less-robust systems might require to get them operating again.

But we do apply that to our food industry. We also have a life science division. That’s where we vet a lot of these technologies before we move them into the military or commercial space to make sure that they’re robust enough and easy enough to use.

We start them in the research market where scientists are much more likely to be able to use them, and if we decide they’re going to be robust enough for the research market, we move them into the food testing, military, and clinical diagnostic markets.

What we’ve learned from our military users is that ease of use is a big thing. The less an operator has to be involved in the operation of the system, the less likely it is that human error will come into play in the final results.

So ease of use, ease of use, ease of use. The easier you can make it, the happier people are with your equipment. It’s kind of the way of the world, but we’ve taken our cues from the military on that point. If we can make our systems extremely easy to use, clinicians and lab folks are going to like them better.

So would you say that Idaho Technologies has a rather easy flow of information and experiences that are shared among disciplines, whether you’re dealing with biodefense military testing, or food testing, or life sciences?

Absolutely. We are a small company. We’re currently about 250 people, but we all draw from the same R&D and engineering resources, and we all draw from these common technology systems and platforms. We have a lot of people working on our defense systems who end up finishing one project there and then moving over to food or moving over to clinical diagnostics.

But our in vitro diagnostic group draws on all of that experience from our military history and our in vitro diagnostic experience with the military. So all of our commercial products that are tracking through FDA clearance and in vitro diagnostics are drawing from the same in vitro diagnostic expertise and knowledge that we use for our military products.

We’re just not a very big company. We aren’t so segmented that all our divisions don’t talk to each other.

To what extent has Idaho Technology been engaged with or been in contact with first responders like local police departments and fire departments and so forth who would, I imagine, be particularly interested in either developing or acquiring various technologies that you’ve developed for the military?

We are very heavily involved in marketing and selling to first responders from police to fire and hazardous-materials fire groups. They’re one of our key customers for these products. It’s a fairly niche product. Outside of the military, that is our customer base.

We usually have a military version that’s specific to the U.S. DOD and a commercial version of the same instrument that we sell to first responders and police. But it’s the same technology and often the same pathogens that we’re targeting. They are part of our core market for military and defense products.

Do the local first responders like police departments, fire departments, and hazmat teams have their own specific needs that they are looking for that may be a little different than what’s already in place for the military?

The military definitely has its own specifications and restrictions on what they’ve paid for us to develop. We usually maintain a certain level of rights and control over the end products so that we are able to sell to the first-responder market. It’s such a small, niche marketplace. We’ve done very, very well in that marketplace, but at the same time, some of these systems that we developed for very niche customers in the U.S. military don’t employ a very high program level or sell in very large volumes. But we still have to keep these instruments supported and sustained for years to come.

They realize that if they’re not going to buy hundreds of these pieces of equipment then we have to be able to commercialize the products and sell them to the first-responder marketplace. Their requirement times often overlap. Even though the firemen aren’t traveling from country to country, they do bounce around a lot in their trucks and they do have to travel to sites to respond to instances and hoaxes such as what we saw in 2001 with the anthrax scare.

There were thousands and thousands of hoaxes out there—people just putting white powder in envelopes. Addressing those incidents required equipment and protective gear similar to what the military uses.

They’ve got many of the same challenges of moving around and needing equipment that’s very, very rugged and very, very easy to use because they have more tasks to do than just biowarfare detection. Most of the time what they’re doing is putting out fires or responding to gas spills—things like that.

What future challenges do you foresee in developing biodefense and military diagnostics? What are your overall views and impressions of the nonclinical diagnostics market?

One ever-present challenge of working with the military is the long procurement process. The acquisition process of the U.S. DOD is a long, drawn-out process. So we want to stay quite ahead of the curve in development for what the military is going to need, and anticipate their needs.

Doing that is not easy, however, because the procurement cycle is so long that they could be writing specifications and designing programs around technology that eventually they’re going to buy, say, in seven years. Guessing whether that technology is going to be obsolete in the same amount of time is a gamble. That’s a tough issue with biotechnology—it does move pretty quickly.

In terms of my impressions of the nonclinical diagnostic market, it certainly is a more difficult marketplace to identify specific niche markets within which you can have a profitable product. The clinical diagnostic market has a lot of money—that’s why so much competition exists there.

In the nonclinical-diagnostics marketplace, margins are much thinner, and it’s a much more difficult market to sell into because it just doesn’t have as much money. The plus side of that, though, is that the regulatory hurdles are much lower. So there is a lower barrier to entry than what exists in clinical diagnostics.

Why do you suppose the regulatory hurdles are lower for the nonclinical diagnostics market?

For food testing, there is a testing group it turns to called the Association of Official Analytical Chemists, and its requirements are fairly strict and fairly high. So the food market has a higher regulatory bar to clear.

The margins on food are quite small, so the cost per test must be very, very low. That’s the challenge in that market space. The veterinary market space and the agriculture market space are two more-difficult areas because, again, it’s all a matter of how much money these people have to spend on testing.

Do you have any additional comments?

Matt Scullion is currently business development director at Idaho Technology Inc. (Salt Lake City) and is responsible for program development, new technologies and market development for ITI. During his time with Idaho Technology, he has been an R&D scientist, a sales manager, a customer support and training specialist, and a marketing manager for applied systems. He can be reached at matts@idahotech.com.