From the U.S. Government Accountability Office, www.gao.gov

Transcript for: Rapid Simultaneous Diagnosis of Multiple Human
Infectious Diseases

Description: Recent advances in science and technology are making it
possible to simultaneously test for multiple infections at the same
time. We talk about the potential benefits to patients and challenges
with bringing this technology to a doctor's office near you.

Related GAO Work: GAO-17-347: Technology Assessment: Medical devices: 
Capabilities and challenges of technologies to enable rapid diagnoses
of infectious diseases

Released: September 2017

[ Background Music ]

[ Tim Persons: ] Imagine now that changing where it's more
patient-centered rather than medical system centered.

[ Jacques Arsenault: ] Welcome to GAO's Watchdog Report, your source for
news and information from the U.S. Government Accountability Office. I'm
Jacques Arsenault. Say you're sick and experiencing nasal congestion, a
really bad cough, and muscle pain. All typical symptoms that indicate
you could have the flu, a common cold, or something more serious. Now
imagine visiting your doctor and instead of your doctor testing for one
infection at a time, that they're capable of testing for multiple
infections all at once. If you're thinking this scenario sounds like a
scene from an episode of Star Trek, bear with me. Chief Scientist Tim
Persons from our Applied Research and Method's team sat down with me
recently to discuss the new technological capabilities and challenges of
being able to rapidly diagnose infectious diseases. I asked Tim to tell
me more about what's in this latest report.

[ Tim Persons: ] Infectious diseases are still a leading cause of death
in the world. For example in the 2015 and 2016 flu season here in the
U.S, 310,000 Americans were hospitalized as a result. There are still
millions that didn't get hospitalized so it just shows just one
infectious disease influenza the impact it has. What of course confounds
the medical staff, the doctors, the physician assistants, the nurses- is
that things ranging from the everyday common cold all the way up to very
scary diseases like the Ebola Virus, which we see recently in this
country, all present with influenza like symptoms. So the key challenge
is how do I know what's flu? Or what's the cold? Or what's something
else more serious. When you look at the fact that 70 percent of all key
medical decisions are informed by diagnostics, then you crosswalk that
with the challenges of healthcare cost, as we know, and then the
emergence of other emerging infectious diseases like we've seen recently
with Zika, then it's a very serious challenge indeed for these
technologies to try and address.

[ Jacques Arsenault: ] So is the idea that you can get the results right
away at the point- of-care like at your doctor's office?

[ Tim Persons: ] This is a key idea Jacques, on that is doing it exactly
as you say at the point-of-care. It could be the doctor's office, it
could be a local clinic, it could be a hospital, even in your own home,
which would be powerful indeed. And be able to do it in a reasonable
amount of time. It could be anywhere from tens of minutes up to two
hours. This challenge is the current model which is a centralized
laboratory approach where you take the blood, or the sputum, or the
urine, those sort of samples, and you send them out, ship them to a
centralized lab usually off-site. And that takes time. For example,
myself when I did my recent annual physical I had a blood draw and it
was going to be shipped off off-site and days to a week later I got a
note from the doctor. Imagine now that changing where it's more
patient-centered rather than medical system centered where they could
tell me an answer within 30 minutes.

[ Jacques Arsenault: ] So with all the things that you're trying to do
what are some of the challenges associated with developing this
technology?

[ Tim Persons: ] Some of the challenges are of course these tools have
to be cost competitive. So you have to be compared to what's the current
cost and that's is in time and money and techniques to be able to take
the test and read the test. So that's one of them. It needs to be of
course, high performing. You don't want to have a lesser performing
diagnostic even though it's measuring multiple things, you want it to
still be as good as the baseline, the singular test that exists today in
the environment. You want to be able to have this, having gone through a
regulatory process, that's easier said than done, of course, and these
devices particular are challenged with that and there are reasons why we
discuss it in the report. But you also want them to be timely and
relevant to the medical market. There wasn't, for example, not too long
ago there was no market for Zika diagnostics and all of a sudden that's
now important. So all these things are challenges there. There's also
the need for the developers to have access to the scientific data, the
clinical samples that they need, as well as these have to be designed
for simplicity. You want to try and get them to not be super complex so
that if you're trying to push it to the point-of-care you don't have to
have a high tech lab technician have to do the work for you.

[ Jacques Arsenault: ] And are the costs for these technologies steep?

[ Tim Persons: ] Development costs are always steep for these devices so
that's why it's still -- there's sort of a now and not yet, some have
already been developed, there's still a lot of work, of course to do.
Just purchasing the device to read the test and so on can be anywhere
from $25,000 to half a million or over half a million dollars, which
again sounds steep but compared to if you're able to get better clinical
outcomes, if you're able to get things sooner, answers sooner, and more
of the answers in one shot, then that actually could have a huge cost
savings, but still that has to be proven out and practiced in at time.

[ Background Music ]

[ Jacques Arsenault: ] It seems like this technology could soon become a
common tool used in doctor's offices in the near future. So I asked Tim,
do the benefits outweigh the challenges and costs of producing these
devices?

[ Tim Persons: ] I think given the promise of the technology and the
breath, again there's a now -- there's some good things going on now so
that gives you reason for optimism. But the impact that these
technologies could have again on cheaper, faster, and potentially more
accurate medical diagnostics or even then projecting that into the
general public health surveillance. So if you're tracking let's say a
flu season and trying to work if you're a public health official to
manage whole populations. Not just a single individual and even what our
Department of Defense, Department of Homeland Security have to care
about with biosurveillance, you know, biodefense in case we have
bioterrorism in our midst. These things have a tremendous opportunity or
provide tremendous capabilities to address those.

[ Jacques Arsenault: ] And, finally what would you say is the bottom
line of this report?

[ Tim Persons: ] The bottom line is that these technologies that enable
these rapid diagnoses of these infectious diseases, again the leading
cause of death in the world are in the now and are to come and again,
could have tremendous impact.

[ Background Music ]

[ Jacques Arsenault: ] Thanks for listening to the Watchdog Report. To
hear more podcasts, subscribe to us on iTunes.

[ Background Music ]

[ Jacques Arsenault: ] For more from the Congressional Watchdog, the
U.S. Government Accountability Office, visit us at gao.gov.