Yourgene Health Presents Data Demonstrating Successful Fetal Fraction Enrichment in NIPT Workflows Following Prolonged Blood Storage in EDTA Tubes
19 Junho 2023 - 5:17AM
Business Wire
- Extended EDTA blood tube storage offers improved flexibility
and cost-saving in NIPT workflows
- Collaborative study with Tommy’s Charity and St Mary’s NHS
Hospital, Manchester
- Data presented at ISPD 2023 in Edinburgh, UK
Yourgene Health plc (“Yourgene”, AIM: YGEN), a leading
international molecular diagnostics group, today presented data
demonstrating that prolonged storage of blood in EDTA tubes is
compatible with non-invasive prenatal testing (NIPT) when using
size selection to enrich the fetal fraction. Scalable and precise
DNA size selection following EDTA tube usage offers a
cost-efficient alternative to the use of more expensive blood
collection tubes (BCTs) and improves next-generation sequencing
(NGS) workflows, reducing the risk of failed screening tests for
expectant mothers. The data is currently being presented at the
27th International Conference on Prenatal Diagnosis and Therapy
(ISPD) in Edinburgh, UK on 19th June 2023.
The collaborative study with Tommy’s Charity and St Mary’s NHS
Hospital (Manchester, UK) used Yourgene’s IONA® Nx NIPT Workflow, a
fully validated clinical workflow which utilises NGS to estimate
the trisomy risk in the fetus. The workflow incorporates the unique
size-selection capability of the company’s proprietary Ranger®
Technology to collect DNA library material within a defined size
range. This step enriches the fetal-derived cell-free DNA (cfDNA)
fragments in samples by reducing the number of larger maternal DNA
fragments. In addition, Yourgene has a patent pending in relation
to the EDTA capability that has been filed.
Many NIPT clinics and hospitals take a maternal blood sample
with an expensive BCT, such as a Streck tube, and the sample is
stable for up to 14 days. However, the data presented has shown the
capability to use EDTA tubes, which are commonly used and a
significantly lower cost, with proven stability up to 7 days.
Sample stability and handling are crucial elements in the
preservation of acceptable levels of fetal fraction and ultimately,
the successful use of NIPT. Cell lysis due to sample instability
can result in the release of maternal genomic DNA, which dilutes
the fetal-derived cfDNA, thereby reducing the fetal fraction. The
results of the study demonstrate that size selection can be used to
recover the fetal fraction from whole blood stored in EDTA tubes
over a prolonged period that exceeds the previous limit of 8
hours.
Dr Joanne Mason, Chief Scientific Officer at Yourgene Health,
said: “The results of Yourgene’s study with Tommy’s and St
Mary’s Hospital greatly improve the feasibility of EDTA tube usage
in NIPT, particularly in situations where delayed transport of
samples between collection site and analysis locations may occur.
There’s also a considerable saving in the cost of the blood
stabilising tubes, and associated licensing fees in the US. This
offers greater flexibility and choice to labs and clinicians, while
providing patients with fast, safe, and accurate screening
results.”
Visit the poster (programme ID P-94) titled “A study to
demonstrate that prolonged storage of blood in EDTA tubes is
compatible with NIPT when using size selection to enrich fetal
fraction” presented at ISPD taking place from 18–21 June. Copies of
the poster will also be available to download from Yourgene’s
website:
https://yourgenehealth.com/our-products/instruments/lightbench-detect/#pac_dtm_child_2
For more information about Yourgene’s IONA Nx NIPT Workflow and
its proprietary Ranger Technology, visit:
https://yourgenehealth.com/our-products/instruments/lightbench-detect/#pac_dtm_child_0
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