Submitting Institution
University of CambridgeUnit of Assessment
Aeronautical, Mechanical, Chemical and Manufacturing EngineeringSummary Impact Type
TechnologicalResearch Subject Area(s)
Chemical Sciences: Analytical Chemistry, Physical Chemistry (incl. Structural)
Biological Sciences: Biochemistry and Cell Biology
Summary of the impact
Research into electrochemical biosensors conducted at the University of
Cambridge between 1998
and 2002 led to the development of the WaveSense™ line of diabetes
products by start-up,
AgaMatrix. By 2012 AgaMatrix had sold 3M glucose meters & 3B biosensor
test strips worldwide
across 20,000+ retail locations including Boots UK, and since 2010 also
globally in partnership with
Sanofi. [text removed for publication] AgaMatrix UK continues to grow its
business with compound
annual growth rates for revenue in excess of 100%. Agamatrix UK now
supplies over one million
glucose test strips per month to the NHS. Agamatrix has developed >10
FDA-cleared products
since 2008, including the first FDA approved smartphone linked diagnostic
device.
Underpinning research
The research on electrochemical biosensors was done in Professor Lisa
Hall's lab in the then
Institute of Biotechnology (now merged with Department of Chemical
Engineering) at the University
of Cambridge between 1998-2002. Hall joined the Institute as a Lecturer in
1985 before promotion
to Reader in 1999 and Professor in 2003. Her group looked at biosensor
construction from first
principles and proposed alternative formats and measurement regimes to
those currently adopted.
Some of the underpinning aspects of this research received EPSRC funding
and were undertaken
by two PDRAs and a Marshall Scholar in Hall's group; Dr. Ian Harding,
Research Associate from
1997 to 2001, now Technology officer at Agamatrix, Dr. Justin Gooding
Research Associate from
1994 to 1996, now Professor at University of New South Wales and Sridhar
Iyengar, Marshall
Scholar 1998-2002 now Chief Technology Officer at AgaMatrix.
The idea emerged through Professor Hall's research on signal
deconvolution using alternating
potential wave techniques in electrochemistry where she showed mechanistic
detail in enzyme
linked biosensors for the first time (ref 1). This was reinforced by
modelling of flow and diffusion
characteristics, enzyme immobilisation, etc. with the outcomes rejecting
many previous
assumptions from others that used an invalid theoretical approximation,
based on an incorrect
assumption of uniform concentration gradients. The work provided key
insight for development of
an improved glucose biosensor (ref 6).
Building on this, the concept proposed by Professor Hall was that better
signal processing and
deconvolution would overcome the limitations identified and deliver a
glucose measurement with
greater integrity in an electrochemical biosensor (ref 1-5).
At the time, common practice was to apply a fixed voltage stimulus to the
electrochemical sensor
and measure a steady-state current. This was a simple method to determine
the concentration of
glucose, but accuracy depended on many factors being constant and known a
priori (e.g. no
chemical interferences in the sample, known electrode area, etc.).
However, in real samples, many
quantities are not known, and in the case of blood samples, there may be
many interfering
substances such as Vitamin C or paracetamol.
The principle inspiration for this impact focused on time-varying
sinusoidal voltage waveforms to
stimulate the electrochemical glucose sensor and generate a reciprocal
sinusoidal response
current, thereby enabling the extraction of time constants related to the
electrochemical reactions
that were either specific to the glucose reaction or to an interfering
substance (such as Vitamin C).
The time-varying nature of this approach inherently generated a
measureable signal that contained
more rich information (as compared to a steady-state response as was the
common case at the
time), and thus subsequently allowed for the separation of the desired
glucose signal from the
interfering signal.
References to the research
* Indicates those references which best demonstrate the quality of the
research
1. Iyengar S, Hall E A H, Skinner N G & Gooding J J. Frequency Domain
Selection of the
peroxide signal for Amperometric Biosensors. Electroanalysis 1998,
10(16), 1089 - 1095.
DOI:
10.1002/(SICI)1521-4109(199811)10:16<1089::AID-ELAN1089>3.0.CO;2-M
2. *Iyengar S, Hall EAH Data from overlapping signals at an amperometric
electrode using
admittance vectors. J Electroanal Chem 2002, 521, 61-71.
DOI:10.1016/S0022-0728(01)00732-X
3. *Iyengar S & Hall E A H. Phasor transform to extract glucose and
ascorbic acid data in an
amperometric sensor. Analyst 2000, 125, 1987-1992
DOI: 10.1039/B005967F
4. *Iyengar S, Hall EAH Selective monitoring of the hydrogen peroxide
signal in the presence of
ascorbic acid. Part II: Preliminary practical realization of applying
immittance spectroscopy.
Electronalysis, 2001, 13 (7), 517-523.
DOI: 10.1002/1521-4109(200105)13:7<517::AID-ELAN517>3.0.CO;2-U
5. Iyengar S & Hall E A H. Selective Monitoring of the Hydrogen
peroxide Signal in the Presence
of Ascorbic Acid: part I: Theoretical Considerations. Electoanalysis
2001 13 (6), 437-444.
DOI:10.1002/1521-4109(200105)13:73.0.CO;2-U
Details of the impact
AgaMatrix was founded in 2001 to develop the research findings described
above. Three members
of Professor Hall's research team were involved in the foundation: Dr.
Iyengar led the foundation
as CTO, Dr. Harding underpinned the core technical team and Professor
Gooding acted in a
consulting and collaborative role. Professor Hall was on the Advisory
Board. The company
generated specific IP by building on Professor Hall's concept of applying
a time-varying input
control and better signal processing and analytics to the signals
generated from an electrochemical
glucose biosensor and developing noise-cancellation algorithms to improve
the accuracy and
reliability of medical devices. AgaMatrix developed this concept into the
WaveSense™ branding.
Agamatix now manufactures a line of diabetes products that features the
"WaveSense" technology,
using the concept of waveform control to detect and correct for errors
caused by differences in
blood samples and environmental conditions. Products include the WaveSense
KeyNote™
(launched 2006 and still available) Presto™ (2007 still available), and
WaveSense Jazz™(Blood
Glucose Monitoring device, or BGM, (2008)), and the WaveSense Diabetes
Manager™ iPhone®
App (2009), an iPhone-connected BGM sold by Sanofi under the brand
IBGStar, and a stand-alone
BGM for Sanofi called the BGStar. Agamatrix has developed >10
FDA-cleared products in the
census period, protected by a suite of more than 120 pending and granted
patents worldwide (ref
7).
In March 2010 AgaMatrix and sanofi-aventis entered into an agreement to
co-develop innovative
solutions in diabetes management that also incorporate WaveSense™
technology. The BGStar
and iBGStar range of BGM devices have been developed out of that alliance
using "WaveSense"
as the sensing platform. The iBGStar was launched in Europe in 2010. In
December 2011, the
US FDA approved the iBGStar, the first approval by the FDA of a smartphone
linked diagnostic
device (ref 7).
[text removed for publication]
Key impact points:
- Invented and manufactured first iPhone-connected glucose meter for
diabetic patients
sold by Sanofi as the "iBGStar" which was covered by the New York Times
and Daily Mail
and is now for sale at Boots (ref 8, 13-14).
- Out of 15,000 health/fitness/medical apps in the iTunes app store,
fewer than 75 have
received FDA clearance, and even fewer have developed regulated
hardware. This puts
AgaMatrix into an elite group of companies at the forefront of
telehealth products targeted
towards patients.
- The iBGStar won the prestigious Red Dot and Good Design awards for
product innovation
— an honor shared by Apple, BMW, Mercedes, and Bose. Products featuring
AgaMatrix
technology have also been honoured by Consumer Reports as "Best Buy"
options in their
category.
- AgaMatrix products are available for sale in over 20,000 pharmacies
and retailer outlets
across the globe.
- Post-market studies show products featuring AgaMatrix technology
already exceed the
recently released ISO standards for home glucose monitoring accuracy
(within 20% of a
standard lab test), achieving closer to within 10% of a standard lab
test (ref 12). The `Up
and Up' branded product sold through Target has received commendations
for its accuracy,
affordability and convenience (ref 9).
- Established a UK subsidiary in the Harwell Innovation Park in 2007
with one Technology
Leader and since 2008 has expanded to employ nine full time staff
- As an example of cost savings to the NHS, the Staffordshire Sentinel
reports that 7500 new
Agamatrix WaveSense Jazz meters will be given to patients in
Staffordshire in 2013,
resulting in a total savings of £350,000 (ref 10,11). By scaling the
estimated savings to a
total population of 80,000, the total savings may be estimated to be £4M
/year and growing.
This assumes that each PCT experiences the same overhead savings that
Staffordshire
experiences.
Sources to corroborate the impact
- CTO, Agamatrix
Statement on file
- New York Times coverage, including FDA
approval: http://www.nytimes.com/2012/02/23/technology/personaltech/monitoring-your-health-with-mobile-devices.html?_r=4&
-
Consumer Reports calls AgaMatrix Technology "Best Buy"
PDF on file
- Devices and Diagnostics Report 2012
PDF on file
- Savings to the NHS based on the article below:
http://www.thisisstaffordshire.co.uk/Gadget-choice-cuts-risk-7-500-diabetics/story-18510795-detail/story.html#ixzz2OYOhxd9w
- Prominent Diabetes Blog confirms accuracy:
http://www.diabetesmine.com/2012/09/why-meters-cant-tell-us-our-blood-sugar-levels.html
- Boots:
http://www.boots.com/en/iBGStar-blood-glucose-meter_1253400/
- Daily mail coverage:
http://bit.ly/A2WdaE
- www.iBGStar.us
- Fast Company Calls AgaMatrix iPhone Meter "Revolutionary"
http://www.fastcodesign.com/1662351/first-look-iphone-add-on-is-a-revolutionary-product-for-diabetics-video