In this issue (2) Collaboration with Queens University Belfast (3) Pilot Production & Medical Diagnostics (4) Working with MBio

Winter/Spring 2016

MBio POINT OF CARE PLATFORM

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MBio Diagnostics has developed a

compact instrument and disposable

cartridge system that performs dozens

of independent tests on a single drop of

a sample, and delivers parts-per-trillion

sensitivity. We will fundamentally

change today’s slow paradigm for

bioanalysis: collect a sample and send it

to the lab. In a clinic, emergency room,

or in the field, our platform rapidly

delivers results wherever they are

needed. The platform enables

applications across multiple industries.

We are licensing the technology for

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various applications and forging

partnerships with both academic and

commercial groups. Our first

commercial partnership was recently

announced, a collaboration and license

deal with Roka Biosciences covering

food safety testing.

Our technology is based on novel

planar waveguides and is covered by a

portfolio of patents. The waveguide

technology enables a simple “load-n-go”

cartridge—new users learn the system

in a matter of minutes. The company

has adapted tests for over 100

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biomarkers to the platform,

encompassing all key analytes: protein,

cells, and DNA. Our comprehensive

platform has been evaluated at 12 sites

on 5 continents. It has been repeatedly

selected as the simplest, most sensitive

and accurate multiplexed point-of-care

system available. Through strategic

partnerships, we are developing

applications for emergency room use,

global health, environmental

monitoring, and food safety testing.

MBio Diagnostics

MBio’s technology will enable a new era of instant-answers in clinical diagnostics and sample testing. Our technology enables on-the-spot testing, wherever and whenever it is needed.

MBio diagnostics

Performance

The MBio LightDeck® technology is a

high performance point-of-care diagnostic

platform: fast, high multiplexing, low

cost, and sensitive. The core patented

waveguide technology enables simple, no-

wash “load-n-go” assay workflow without

compromising performance. Assays can

be performed in as few as 2 or 3 minutes.

For simple multiplexing, MBio has few

competitors. The image shown is an 88-

feature array delivering quantitative results

on 57 different serological assays.

Compared to Luminex and MSD, MBio

can deliver comparable multiplexing in a

simple field portable system. The MBio

sensitivity results rival those of highly

complex, lab-based solutions. The data

below shows a comparison between an

MBio IL-6 assay and a commercial ELISA

kit, with sensitivity down to a few

pg/ml—ideal for markers like IL-6,

cardiac troponin, or HIV p24.

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Several years ago, MBio was

approached by researchers from

Queen’s University Belfast (QUB),

who were interested in developing

tests related to food safety, specifically

multiplex detection of harmful marine

and freshwater toxins. This is a

leading problem in water resources

and shellfish beds, as exemplified by

the shutdown of the Toledo municipal

water supply in 2014, and the recent

outbreak of multi-toxin algal blooms

in the US Pacific Northwest in 2015.

In the case of mixed toxin algal

blooms, the analytical challenge for

field-screening assays is high.

Conventional technology requires

multiple test strips. Ideally, a

screening tool would comprehensively

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cover the likely algal toxins for that

body of water.

We worked with Professor Chris

Elliott and his team to define a panel

of five toxins that are commonly found

in hazardous algal blooms. Each of

these toxins could severely sicken a

consumer, with a range of

neurotoxins, hepatotoxins, and

vomittoxins. We set about developing

the custom 5-plex panel, which was

the basis for a series of publications to

date by the QUB group.

Professor Elliott and his colleagues

were impressed, noting “The highly

innovative assay was proven to

accurately detect toxin … at an

unprecedented cell density of 10

MBIo Partners with

Queen’s University Belfast

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cells/L.” [1] In fact, they took on

assay development and manufacturing

of cartridges using MBio components.

They have forged ahead in a number of

applications, and even demonstrated a

multiplex milk assay with a

commercial partner. [2]

Professor Elliott introduced the MBio

technology to the EAGER consortium,

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and now under NSF funding the MBio

system is being integrated into an

autonomous underwater vehicle, in

collaboration with the Monterey Bay

Aquarium Research Institute.

In summary, the QUB group has been

a wonderful collaborator with MBio,

resulting in great science, multiple

publications, and follow-on funding.

Pilot production

The MBio platform has been designed for

manufacturability from day one. The

disposables are constructed from simple

injection molded plastic, with a highly

scalable print-and-assembly operation.

The automated print process, developed

using Scienion automation, deposits tiny

quantities of reagents. The manufacturing

process has been thoroughly audited by

partners, and the plans have been set to

produce millions of disposable cartridges

per year. Our pilot production plant for

cartridges in Boulder Colorado can

produce up to 2,000 disposables per week

under our ISO13485 quality system, and

we can scale to meet the needs of our

partners. The instrument is built on

CMOS imaging technology and diode

lasers, the same technologies found in your

camera phone and DVD player,

respectively. These design choices make

for robust, affordable instrumentation,

without compromising on performance.

Medical diagnostics Our mission in medical diagnostics is simple: to become the “go-to” platform for

instant diagnosis at the point of care. The MBio platform is ideal for delivering

multiple results in a clinic, ICU, or doctor’s office, whether in New York or

Nairobi. Just a single drop of blood is applied to an MBio cartridge, where it flows

by capillary action, and multiple results are reported in a matter of minutes. Tests

for HIV, hepatitis, and influenza have been demonstrated in diverse settings ranging

from San Diego and Seattle, to Kenya and Brazil. Stay tuned to hear about our

upcoming work on malaria and sepsis.

Mbio diagnostics Newsletter Winter/spring 2016

Collaborating with MBio MBio scientists and engineers are able to help you translate an assay or set of assays onto our

platform. A typical commercial engagement follows a common process: (1) A prototype assay

is developed using your reagents and qualified samples (positives/negatives, or quantitated

samples), (2) the assay is validated against a blinded set of samples and the data shared, and (3)

the assay cartridges are shipped to you for use in your application. We charge a nominal fee to

perform these development activities, and we invest the time necessary to ensure an attractive

result. Once an assay or panel is validated, MBio can produce and ship additional cartridges as

needed. When a product is ready for commercialization, we transfer to manufacturing, and

then set up a supply agreement and license to ensure your ability to commercialize. We can

tailor a set of terms that meet your business needs. With academic collaborators, we have

structured multiple collaborations and together won extensive funding for the academic labs

and research centers that work with MBio technology. How can we serve you?

MBio Diagnostics, Inc. 5603 Arapahoe, Suite 1 Boulder, CO80303

Selected Articles by the Queen’s University Belfast Group: 1. Meneely, J.P., et. al., Biosens. Bioelectron. (2012), http://dx.doi.org/10.1016/j.bios.2012.09.043 2. McGrath, T.F., et. al., Anal. Bioanal. Chem. (2015), http://dx.doi.org/10.1007/s00216-015-8526-4

Meet us at the 2016 Molecular Medicine Tri-Conference in San Francisco Chris Myatt Speaking at the Point of Care Symposium on March 11