RCS - EKF Diagnostics Hldg - Strategic partnership agreement with Yourgene

EKF Diagnostics HoldingsAnnouncement

18/01/2022 07:05

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RNS Number : 7435Y  EKF Diagnostics Holdings PLC  18 January 2022

EKF Diagnostics Holdings plc

("EKF", the "Company" or the "Group")

 

Strategic 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
(https://www.acog.org/advocacy/policy-priorities/non-invasive-prenatal-testing)
 

2(     )
www.researchandmarkets.com/reports/5354677/u-s-non-invasive-prenatal-testing-mark
(http://www.researchandmarkets.com/reports/5354677/u-s-non-invasive-prenatal-testing-mark)
et

 

 

 

 EKF Diagnostics Holdings plc                                  www.ekfdiagnostics.com (http://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 & Joint Broker)                                   Tel: +44 (0)20 7496 3000
 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 (mailto: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
(http://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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