TIDMEKF
EKF Diagnostics Holdings PLC
18 January 2022
EKF Diagnostics Holdings plc
("EKF", the "Company" or the "Group")
S trategic partnership agreement with Yourgene Health plc
Collaboration to broaden testing capabilities through EKF's
accredited US laboratory beyond COVID-19
EKF Diagnostics Holdings plc (AIM: EKF), the AIM-listed
point-of-care business, has signed a strategic partnership
agreement with Yourgene Health plc ("Yourgene", AIM: YGEN), a
leading international molecular diagnostics group, whereby EKF will
offer a non-invasive prenatal test ("NIPT") service to the US
market based on Yourgene's proprietary Flex technology, using EKF's
accredited US laboratory to process returned test samples. Over
time, EKF and Yourgene intend to provide further tests including in
oncology, for which Yourgene has additional tests. The agreement is
for an initial 5-year period.
EKF's facilities are those of Advanced Diagnostic Laboratory LLC
("ADL Health"), a recently acquired Texas based testing laboratory
certified under the Clinical Laboratory Improvement Amendments
("CLIA") for high complexity testing. ADL Health has the in-house
testing capabilities to broaden its diagnostics offering from its
current range of rapid and accurate COVID-19 testing services into
the expanding market of NIPT, amongst other areas. This partnership
with Yourgene enables EKF to follow its strategy to grow its CLIA
laboratory business beyond COVID.
As part of the agreement, EKF will purchase state-of-the-art
next generation sequencing ("NGS") technology ("Illumina NextSeq
550") and Yourgene's proprietary technology, to enable ADL to build
NIPT screening services for a wide range of clinical conditions
across reproductive health (including Down's Syndrome and other
genetic disorders). It also provides the opportunity to use NGS
technology independently to extend EKF's testing capabilities into
other areas such as cardio-vascular disease testing (designed to
determine the genetic predisposition towards cardiomyopathy,
hypercholestermia, and other risk factors), hereditary cancer risk,
genetic predisposition for Alzheimer's disease, Parkinson's disease
and dementia.
The adoption for NIPT in the US has accelerated with recent
guidelines issued from American College of Obstetricians and
Gynaecologists ("ACOG") recommending NIPT to be made available to
all pregnant women(1) . As part of the agreement, Yourgene will
provide ADL Health with access to YGEN's proprietary reagents and
NGS analysis software as part of a technology transfer agreement to
enable ADL Health to build a rapid turnaround NIPT service for the
US market. Currently, a majority of US NIPT samples are sent to
large central testing laboratories, which are costly and experience
lengthy lead times . In contrast, the new ADL NIPT service will
offer rapid turnaround times as the NIPT workflow can be performed
in as little as 48 hours, enabling a competitive response and
allowing both EKF and Yourgene to gain traction in this large
growing market. According to third party forecasts, the US NIPT
market is expected to reach a valuation of USD 2.5 Billion by
2028(2) .
Within the collaboration Yourgene will also provide ADL Health a
range of YGEN's additional PCR portfolio for screening Cystic
Fibrosis, rapid aneuploidy assay and DPYD (chemotherapy toxicity)
tests, creating a wider range of products for use in reproductive
health and oncology.
Mike Salter, Chief Executive Officer, commented: "We are
extremely pleased to have formed this partnership with Yourgene,
allowing EKF to offer NIPT and oncology tests as part of its
proposed strategy of expanding its CLIA laboratory testing
portfolio beyond COVID-19 assays. We are thrilled to be growing our
reach further within the largest healthcare market in the world and
look forward to working with Yourgene going forward."
Lyn Rees, Chief Executive Officer of Yourgene, commented: "We
are thrilled to have entered into this collaboration with EKF and
ADL Health, a well-established group in the US with a large
clinical network of customers positioned to increase uptake of the
tests. This partnership is testament to the strength of our
technical capabilities and accelerates our US growth plans to
broaden our portfolio in the region with strategic partners. I am
excited to be working with EKF and this partnership is a great
platform for growth within the largest healthcare market in the
world."
1 ACOG Practice Bulletin No. 226. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2020;136:e48-69),
summarised at
https://www.acog.org/advocacy/policy-priorities/non-invasive-prenatal-testing
2
www.researchandmarkets.com/reports/5354677/u-s-non-invasive-prenatal-testing-mark
et
EKF Diagnostics Holdings plc www.ekfdiagnostics.com
Christopher Mills, Non-executive Chairman Tel: +44 (0)29 2071 0570
Mike Salter, CEO
Marc Davies, CFO
Singer Capital Markets (Nominated Adviser & Tel: +44 ( 0)20 7496 3000
Joint Broker)
Aubrey Powell / George Tzimas / Tom
Salvesen
Investec Bank plc (Joint Broker) Tel: +44 (0)20 7597 4000
Gary Clarence / Daniel Adams
Walbrook PR Limited Tel: +44 (0)20 7933 8780 or ekf@walbrookpr.com
Paul McManus / Lianne Applegarth Mob: +44 (0)7980 541 893 / +44 (0)7584 391
303
About EKF Diagnostics Holdings plc ( www.ekfdiagnostics.com
)
EKF is a leading point-of-care diagnostics and central
laboratory assay manufacturer with an estimated 80,000 hemoglobin,
hematocrit, HbA1c, glucose and lactate analysers in regular use
across more than 100 countries. EKF specialises in developing tests
for use in anemia and diabetes diagnosis and management, as well as
providing a portfolio of reagents for use in clinical chemistry
analysers.
EKF specialises in the development, production and worldwide
distribution of point-of-care analyzers and clinical chemistry
reagents for use in hospital and research laboratories, doctor's
offices, blood banks and for in-field anaemia screening programmes.
EKF is also a bulk manufacturer of enzymes and has custom
manufacturing facilities across sites in the US, UK and Europe for
a variety of life science products. Driven by customer demand EKF
has invested significantly in increasing the Company's fermentation
capacity. The Company's capabilities and capacity in contract
manufacturing for sample collection, tests and test kits have seen
dramatic growth following strong demand for during the COVID-19
pandemic, and these income streams are now being diversified for
application to other non-COVID areas of diagnostic testing,
molecular disease and forensic test manufacture.
In May 2021, EKF outlined its strategy through to 2024 for
delivering additional growth. As well as the growth expected in
Contract Manufacturing across Life Sciences, molecular diagnostics
and other applications, the Company expects to leverage existing
distribution channels for organic growth, both in the core business
and from additional products to expand the core range, but also
through executing earnings enhancing acquisitions and delivering
further value creating investments associated with the preferred
partnership agreement with Mount Sinai Innovation Partners.
In October 2021, EKF completed the acquisition of Advanced
Diagnostic Laboratory LLC, a Texas based testing laboratory
certified under the Clinical Laboratory Improvement Amendments
("CLIA") for high complexity testing. The laboratory provides
testing for a variety of clinical, forensic and microbiological
sample types using a range of analytical techniques. This
acquisition positions EKF as a leading 'one stop' provider of
diagnostic products and services from sample collection to
results.
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