US partnership with EKF for NIPT and genomic tests

RNS Number : 7436Y

Yourgene Health PLC

18 January 2022

 

Yourgene Health plc

("Yourgene" or the "Company")

US partnership with EKF Diagnostics for NIPT and additional genomic tests

Collaboration with EKF Diagnostics to use its accredited US laboratories for NIPT and Oncology testing

Manchester, UK - 18 January 2022: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces that it has signed a strategic partnership agreement with EKF Diagnostics Holdings plc ("EKF", AIM: EKF), a point-of-care business with accredited laboratory testing capabilities in the US, whereby EKF will offer an NIPT service to the US market based on Yourgene's proprietary non-invasive prenatal technology for an initial 5-year period.

Recently acquired by EKF, Advanced Diagnostics Laboratory LLC ("ADL Health"), a Texas based PCR-focused testing laboratory certified under the Clinical Laboratory Improvement Amendments ("CLIA") for high complexity testing, has the in-house testing capabilities to broaden its diagnostics offering into NIPT through a partnership with Yourgene.

The adoption for NIPT in the US has accelerated with recent guidelines issued from American College of Obstetricians and Gynecologists ("ACOG") recommending NIPT to be made available to all pregnant women¹.   As part of the agreement, Yourgene will provide ADL Health Laboratories with access to their proprietary reagents and NGS analysis software as part of a technology transfer agreement to enable them to build a rapid turnaround NIPT service for the US market. Currently in the US, the majority of NIPT of samples are sent to large central testing laboratories in the US, 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 companies to gain traction in this large growing market. The US Non-Invasive Prenatal Testing (NIPT) market is expected to reach a valuation of USD 2.5 Billion by 2028².

As part of the collaboration, Yourgene would provide ADL a range of tests from the Company's additional PCR portfolio for screening Cystic Fibrosis, rapid aneuploidy assay and DPYD (Chemotherapy toxicity test) tests, creating a wider range of reproductive healthcare products and allowing Yourgene to enter the oncology market in the US for the first time.

Mike Salter, Chief Executive Officer of EKF, 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 further our reach 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. http://www.researchandmarkets.com/reports/5354677/u-s-non-invasive-prenatal-testing-market

This announcement contains inside information for the purposes of the UK Market Abuse Regulation.
The Directors of the Company take responsibility for this announcement.

Yourgene Health plc Lyn Rees, Chief Executive Officer	Tel: [phone] [e-mail]
Barry Hextall, Chief Financial Officer
Joanne Cross, Director of Marketing
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About Yourgene Health

Yourgene Health is an international molecular diagnostics group which develops integrated genomic technologies and services enabling precision medicine. The group works in partnership with global leaders in DNA technology to advance diagnostic science. 

Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and now infectious diseases. The Group's flagship products include non-invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, and a recent extension into the oncology space with DPYD genotyping.

The launch of Yourgene Genomic Services has enabled Yourgene to offer a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post-market stages to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene Genomic Services offers an NIPT and high throughput COVID testing service.

In August 2020, Yourgene acquired Coastal Genomics , Inc., a sample preparation technology company based in Vancouver, Canada, enabling the Company to extend its offering and IP portfolio in the DNA sample preparation sector. The acquisition increased Yourgene's geographical penetration into the US and Canada, supplementing existing coverage in the UK, Europe, MEA and Asia.

Yourgene Health is headquartered in Manchester, UK with offices in Taipei, Singapore, the US and Canada, and is listed on the London Stock Exchange's AIM market under the ticker "YGEN". For more information visit www.yourgene-health.com and follow us on twitter @Yourgene_Health.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

 

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