Medilink NOE News Summer 2020 Summer 2020 | Page 4

BRANDON MEDICAL SOURCES VENTILATORS
FOR NHS NIGHTINGALE HOSPITAL
Brandon Medical, a
global medical lighting company
supplying hospital and healthcare
lighting systems, and our member,
has sourced ventilators from the
British company, Meditech, for the
NHS Nightingale Hospital North West
in Manchester.
The company also supplied
examination lights suitable for
tracheotomy to the NHS Louisa
Jordan temporary emergency
hospital at Glasgow’s SEC Centre.
It has offered advice to Leeds
Teaching Hospitals NHS Trust and
Leeds University on increasing the
distribution of oxygen and medical
Yourgene a leading international molecular diagnostics
group and Medilink member has announced that it has
achieved CE-IVD marking for its Clarigene™ SARS-CoV-2
in vitro diagnostic kit, for diagnostic use. The CE-IVD
version of the Clarigene™ SARS-CoV-2 test will be
used in Yourgene’s high throughput COVID-19 service
lab in Manchester and will allow Yourgene to provide
corporate partners and healthcare settings, such as care
homes and private GP practices, with a fast and reliable
COVID-19 lab testing service.
The test is a RT-qPCR (real-time quantitative polymerase
chain reaction) assay which detects the presence of SARS
CoV-2 viral RNA. The assay uses two viral RNA targets,
nucleocapsid gene (‘N’) andenvelope gene (‘E’), which are
SARS-CoV-2 specific and this prevents any cross reactivity
with other Coronaviruses.
The use of dual viral targets and assay controls provides a
more reliable result, whilst also making it more desirable
across several European regions which require the dual
viral targets for reimbursement.
air, and is manufacturing parts for the UK
ventilator programme – including for the
new Mercedes-UCL CPAP ventilator and
existing British-made machines.
Brandon Medical has a large stock of
medical gas terminal units and hose
assemblies which may assist in the
provision of larger scale distribution.
These include medical lights for intubating
patients and tracheotomy, some medical
gas parts for oxygen and medical air
pipelines, ICU pendants, medical point
of care computers, medical IT systems
(special electrical isolated power supplies
for ICU and theatres- formerly known as
IPS), as well as operating theatre items
and components.
At the beginning of the pandemic,
the company increased its
production to meet the demand
from the NHS and help in the fight
against the virus.
For more than 70 years, Brandon
Medical has provided healthcare
professionals with reliable, highquality
and affordable medical
equipment packages for operating
theatres and critical care.
CE-IVD MARK FOR CLARIGENE™ SARS-COV-2
TEST FOR YOURGENE HEALTH PLC
Clinical validation of the test has shown >99.9% accuracy
with no false positive or false negative results. Additional
studies have shown 100% repeatability data and an average
>99.7% reproducibility.
The Clarigene test only detects SARS CoV-2 RNA and
shows no cross reactivity with other respiratory viruses.
Inadequate sample collection has been a significant issue
in the global pandemic and the Clarigene test kit has an
internal control that detects poor-quality samples to give
an invalid result, allowing greater confidence in negative
results.
Lyn Rees, CEO of Yourgene, commented: “I would like to
congratulate the Yourgene team for their hard work in
achieving the CE-IVD mark for the Clarigene™ SARS-CoV-2
Test in such a short amount of time. There is a significant
opportunity to drive sales of the Clarigene™ SARS-CoV-2
kits, however we understand that the COVID-19 testing
market is dynamic and with this in mind, we will commit
to updating shareholders on a quarterly basis on the
commercial take-up of this product.”
UK COVID-19 RAPID
ANTIBODY TESTS APPROVED
FOR PROFESSIONAL USE
The COVID-19 rapid antibody test, developed by
Medilink member Abingdon Health, the medical device
manufacturer leading the UK-Rapid Test Consortium
(UK-RTC), has received its CE mark. This means it is
approved for professional use in the UK and EU.
This milestone means the rapid test, for detection of IgG
antibodies to the SARS-CoV-2 virus (COVID-19) is now
available for distribution for professional use. It will be
mass produced and tests will be rolled out from the end
of August. The test can be administered by healthcare
professionals, such as doctors, nurses, pharmacists
and healthcare workers.
Following production of tens of thousands of tests
across multiple production scale batches the test
has been shown to be 99.40% accurate. Testing
was performed at the Ulster University and at the
laboratories of Abingdon Health.
The test will be named the “AbC-19TM Rapid Test”. It
uses a small drop of blood from a finger-prick, and
shows results in 20 minutes, without the need to send a
sample to a lab.
The test can help build a swift and clear picture of how
the virus has spread throughout mass populations. It
can also help establish the effectiveness of any vaccine
which provides protection by creating new antibodies.
This information will be critical to managing current
and future outbreaks of COVID-19.
To develop and mass produce the volumes needed
for the UK population, Abingdon Health set up and
led the UK-RTC in April this year. The consortium
brings together the UK’s largest rapid test medical
manufacturers, working together to provide capacity for
delivery of more than a million tests per month.
The company has fast-tracked development and
completed CE marking in just 14 weeks. This process
would normally take 10 months or more.
In total, the UK-RTC can manufacture 10m tests within
a six-month period. Abingdon Health has acquired
all the materials needed for all the members of the
consortium to manufacture the test for this initial 10m
tests and the consortium is now ready to produce this
high quality test at scale.
Abingdon Health CEO Chris Yates said:
“This UK designed, developed and manufactured highquality
rapid diagnostic test is a breakthrough for UK
life sciences and a triumph of British business.
WORLD LEADING ORTHOPAEDIC
MANUFACTURER TO OPEN NEW
FACILITY
Orthoplastics, a Medilink member and a world leader in
the development and supply of implantable-grade plastics,
has announced a significant investment in a new facility in
the North West. The company, which was founded in 2005,
is a pioneer within the orthopaedic sector and focuses on
providing end-to-end solutions for medical device OEMs.
The investment, which comes in the form of another largescale
manufacturing facility, is a huge vote of confidence in
the Northern Powerhouse region, which has a flourishing
life sciences manufacturing sector. It further increases the
company’s market capabilities and will create around 100 new
jobs at the Futures Business Park Development, which is in
the heart of the Rossendale Valley and in the constituency of
the former Minister for the Northern Powerhouse, Jake Berry
MP. The Government’s Industrial Strategy puts innovation at
its heart, and wants to encourage the discovery, innovation
and commercialisation of cutting-edge ideas. Orthoplastics
is a typical example of this kind of company and has been
developing technological solutions for the manufactur of
high-performance, implantable medical devices for 15 years.
Mark Allen, Managing Director, Orthoplastics said,
“Innovation is at the heart of the future of UK manufacturing,
and this factory will provide our customers with the
confidence in our long-term investments strategy, whilst
demonstrating our strategic partnership and commitment.”
The new facility is due to open in early 2021 and will attract
an annual investment of £5 million from the company. This
long-term UK manufacturing investment demonstrates
the confidence the company has both in its domestic and
international markets, even at this uncertain time. The news
comes as the Prime Minister announces a boost for UK
science, with top scientists given fast-tracked entry to the UK
– a major boost for the sector.
“This significant investment underlines our belief that
there is huge potential for innovation and growth within the
Orthopaedic sector. It is also the next step towards achieving
our ambition of pioneering improved patient outcomes
and the longevity of implantable medical devices. Joint
replacement procedures such as HIP and knee surgeries are
highly successful of course, but we are leading the way in
the evolution of new concepts to improve these life changing
operations”, Mr Allen said.
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