Novel molecular diagnostics, leading to fast detection of infection biomarkers, creates a new business venture for Mölnlycke Health Care
Submitting Institutions
University of St Andrews,
University of EdinburghUnit of Assessment
PhysicsSummary Impact Type
TechnologicalResearch Subject Area(s)
Chemical Sciences: Analytical Chemistry
Biological Sciences: Biochemistry and Cell Biology
Technology: Medical Biotechnology
Summary of the impact
Impact: altered business practice / new business venture created
Research into biophysical detection methods undertaken within PHYESTA has
resulted in a Gothenburg-based multi-national, Mölnlycke Health Care,
establishing a Scottish subsidiary (MHC Scotland) to exploit a commercial
(exclusive license) partnership involving PHYESTA and Scottish Enterprise.
This represents (i) creation of a new business sector for the company, and
(ii) adoption of a new technology into its portfolio.
Significance:
Mölnlycke Health Care has used its access to PHYESTA's IP portfolio, via
license arrangements, as the primary vehicle for creating a new business
venture enabling its entry into the diagnostics market for the first time.
Reach:
Mölnlycke Health Care is a leading innovator in infection control in
hospitals with employees in 30 countries worldwide. Its entry into the
diagnostics market has implications for the entire company.
Beneficiaries:
Impact in 2011-2013 pertains primarily to Mölnlycke Health Care and to the
Scottish economy.
Attribution: This work was led by Professor Jason Crain, in
collaboration with Professor Andrew Mount (Chemistry), Professor Peter
Ghazal (Medicine), and Professor Anthony Walton (Engineering).
Underpinning research
The underpinning research was highly interdisciplinary involving several
research Centres in Edinburgh: the COSMIC research facility (Physics -
Crain), Genomic Technology and Informatics (Medical School — Ghazal), the
Scottish Microelectronics Centre (SMC — Walton) and the School of
Chemistry (Mount). It addressed major limits on detection capabilities of
infections in situations relevant to a clinical context. Initial work on
novel molecular detection methods included the development and subsequent
patenting of a novel class of DNA bio-switches [R1, R2, R3]. These were
demonstrated to be highly discriminating sensors of nucleic acids. The
devices employ a unique method of molecular recognition in which the
optically detected switch characteristics are modified in the presence of
an unlabelled target. Subsequent work led to several novel modes of
detection and signal amplification in complex biological matrices.
Subsequently the same collaboration developed a method for label-free
electrochemical impedance immunosensing and demonstrated application of
this method to the detection of infection biomarkers directly from
biological matrices [R4]. The results showed that there was sufficient
sensitivity for rapid and clinically relevant wound infection detection. A
method for label-free, electrochemical impedance immunosensing for the
detection and quantification of several infection biomarkers was
demonstrated. Triggering of Receptor-1 Expressed on Myeloid cells (TREM-1)
and Matrix MetalloPeptidase 9 (MMP-9) were detected via direct assay.
Other compounds relevant in bacterial quorum sensing were detected using
competition assays.
Detection was achieved in less than 1 hour straight from mock wound fluid
without any extensive sample preparation steps. The sensitivity of
detection was already near or above the level required for reliable
diagnosis of infection. Subsequently, an MRSA (hospital superbug) assay
requiring neither labelling nor amplification of target DNA was reported
[R5]. Sequence-specific binding of bacterial genomic DNA fragments could
be detected at femto-molar concentration using electrochemical impedance
spectroscopy (EIS). Observed detection levels fully met the clinical
requirements, where the usual definition of an infected wound is 105
cells/mL.
Personnel:
Key PHYESTA researchers involved were Professor Jason Crain (1993-present)
and Gerard Giraud (PDRA 2009-2011).
References to the research
The quality of the underpinning research is best illustrated by R1, R4
and R5. [Number of citations]
| [R1] |
Giraud, G; Schulze, H; Bachmann, TT, Crain J et al., “Solution
state hybridization
detection using time-resolved fluorescence anisotropy of quantum
dot-DNA
bioconjugates”, Chemical Physics Letters 484, p.
309-314 (2010)
DoI: 10.1016/j.cplett.2009.11.032, [10]
|
| [R2] |
Campbell, CJ; Mountford, CP; Stoquert, HC and J. Crain, “A DNA
nanoswitch
incorporating the fluorescent base analogue 2-aminopurine detects
single nucleotide
mismatches in unlabelled targets”, Analyst 134,
p.1873-1879 (2009)
DOI: 10.1039/b900325h, [2]
|
| [R3] |
Buck, AH; Campbell, CJ; Dickinson, J. Crain et al., “DNA
nanoswitch as a biosensor”,
Analytical Chemistry 79, p. 4724-4728 (2007)
DOI: 10.1021/ac070251r, [14]
|
| [R4] |
Ciani, Ilenia; Schulze, Holger; Corrigan, Damion K.; Crain Jason,
et al., “Development
of immunosensors for direct detection of three wound infection
biomarkers at point of
care using electrochemical impedance spectroscopy”, Biosensors
& Bioelectronics 31
p. 413-418 (2012), DOI: 10.1016/j.bios.2011.11.004, [8]
|
| [R5] |
Corrigan, Damion K.; Schulze, Holger; Henihan, Grace; Crain, Jason
et al.,
“Impedimetric detection of single-stranded PCR products derived
from methicillin
resistant Staphylococcus aureus (MRSA) isolates”,
Biosensors & Bioelectronics 4, p.178-184 (2012),
DOI: 10.1016/j.bios.2012.01.040, [3]
|
Details of the impact
Mölnlycke Health Care is a world-leading manufacturer of wound care
products and a major service provider to the healthcare sector. Its annual
sales have grown rapidly from EUR 770M in Q4 2007 to EUR 1,120M in 2012 of
which approximately 40% derives from its Wound Care Division with the
remainder coming from its Surgical Division. Mölnlycke Health Care has
sales operations in 30 countries and 7400 employees worldwide. In wound
care management, the company has recognised (a) the pressing requirement
for the development of rapid and sensitive technologies for portable
medical diagnostics, and (b) that disruptive technologies can arise from
research at the physical/life science interface. The company's current
estimates suggest that automated platforms for chronic wound diagnosis
will address a global market opportunity of between £1.4bn and £2.8bn by
2017. In many cases, accurate and rapid diagnosis of wound infection can
inform treatment and guide isolation measures. Related to this, bacterial
resistance to antibiotics is a public health issue of increasing
significance, and there is growing urgency not only for new treatments,
but also for improved diagnostics of often-lethal infections such as MRSA
(the hospital "super-bug"). Reduced efficacy of antibiotics, and the
increasing emergence of resistant strains, present serious problems for
the healthcare industry generally. They represent a key target area for
Mölnlycke Health Care across its wound-care operations.
Against the backdrop described above, Mölnlycke has, as a matter of
priority, sought a route to establishing a competitive presence in the
diagnostics market for wound infection to complement and enhance its
sector-leading business in wound-care treatments. This has now been made
possible as a direct result of underpinning research conducted by the
PHYESTA-led team. PHYESTA's research on electrochemical impedance
spectroscopy (EIS) has created a particularly attractive and sensitive
detection mode which can be readily incorporated into point-of-care
platforms. This meets the requirements of Mölnlycke Health Care for a
clinically deployable solution with improved performance over existing
methods, which is compatible with rapid clinical response in infection
control. Demonstrator experiments have illustrated the performance of the
methodology for specific biomarkers of interest. The elimination of the
PCR (polymerase chain reaction) amplification step, which forms the basis
of many biomarker assays but usually takes several hours and/or skilled
sample preparation, represents an IP-protected disruptive technology; it
is a key aspect of the attractiveness of PHYESTA's diagnostic
methodologies to Mölnlycke [F1].
The direct detection by EIS of wound-infection biomarkers emerged as
particularly well aligned to Mölnlycke Health Care's core business
interests, and was chosen as the primary focus for discussions between
PHYESTA researchers, their Edinburgh collaborators, and MHC that were
brokered initially by Scottish Enterprise — Scotland's national economic
development and investment agency. In August 2011, Scotland's Finance
Minister announced the completion of a business partnership with Mölnlycke
Health Care whereby the company has taken an exclusive licence to IP from
the Edinburgh team's research project portfolio and established a new
Scottish subsidiary company: MHC Scotland Ltd. The subsidiary commenced
operations on 3rd September 2012 and is located in Building 9 BioQuarter,
within Scotland's flagship life science incubator.
The establishment of MHC Scotland, and in particular its role in the
fight against MRSA, has generated significant press coverage [S1].
Scottish Enterprise has assisted Mölnlycke Health Care in setting up its
facility at the BioQuarter, culminating in the creation of a new
Diagnostic Division of MHC which is led from its new Edinburgh subsidiary.
The impact in 2011-2013, deriving from the underpinning research, is
primarily on Mölnlycke itself and on the Scottish economy, as evidenced by
(i) the formation of a significant new business venture and (ii) an
alteration of business practice through the adoption of a new technology
and the creation of a new Diagnostic Division.
As of 2013, MHC Scotland employs 8 full time staff members. Expansion is
expected, and while the direct economic and healthcare impacts will occur
only after the current REF period, these developments already establish
substantial impact by changing the business plans of a major multinational
company. Indeed, Mölnlycke's primary reason for starting inward investment
to the UK has been to exploit the results of the PHYESTA-led Edinburgh
research team. In a recent press statement [S2] the CEO of Mölnlycke
Health Care comments "We are delighted to be expanding our
capabilities and product offering in close collaboration with Scottish
Enterprise and the University of Edinburgh. This initiative marks our
entry into the diagnostic market. We are very proud to be extending our
offering of efficient infection control and prevention solutions that
make life easier and safer for health care professionals and patients."
Formation of MHC Scotland also represents the first (and so far only)
international inward investment to the BioQuarter which is an important
part of Scottish Enterprise's delivery plan for economic benefit from the
life sciences. The Senior Director of Scottish Enterprise, said that [F2]:
"Scotland's life sciences industry contributes over £3 billion a year
to the Scottish economy. [It is] our role to ensure that this continues
and Scottish Enterprise is committed to encouraging more ambitious life
sciences companies at all stages of development, from new spin-out firms
to major international corporations to locate at the world-leading
Edinburgh BioQuarter."
Sources to corroborate the impact