Ranger® Revolution - LightBench® Detect is Here!
The wait is over! Yourgene Health are proud to today reveal the Ranger® Revolution in the form of the LightBench® Detect; the latest addition to our Ranger® Technology portfolio. We’ve worked closely with our clinical laboratory partners to develop a size selection instrument that is optimised for improving the performance of liquid biopsy workflows, most notably non-invasive prenatal testing (NIPT). The LightBench® Detect addresses a pressing need for NIPT providers to be able to reduce no-call rates by optimising average fetal fraction. Additionally, by leveraging patent-pending size-selection technology from Yourgene Health, the LightBench® Detect is the only size-selection instrument that enables laboratories to consider the use of EDTA blood collection tubes (BCTs) instead of Streck BCTs.
Ranger® Technology in NIPT – 3-in-1 Solution
Ranger® Technology offers industry-leading scalability and precision for the DNA size selection process. The core size selection functionality is complemented by the ability to perform fragment length analysis and fluorescence assays for quality control purposes. Since cfDNA fragments of fetal origin are typically <150bp in length, size selection using Ranger® Technology can enrich for fetal fraction to reduce the number of no-call results or screening failures. Use of the technology in NIPT has already been demonstrated to secure an average recovery yield of over 70%. Unlike traditional electrophoretic size selection approaches, >97% reproducibility is possible, and ensures consistent enrichment of the fetal fraction.
The existing LightBench® specifically addresses the needs of research applications, including metagenomics and sequence discovery.
EDTA BCTs in NIPT
Recent work presented by the Centre de recherche du CHU de Québec-Université Laval, demonstrated a patent-pending ability of Ranger® Technology to enable laboratories to consider the use of EDTA BCTs instead of Streck BCTs in their workflows (1). The group worked with Yourgene Health to compare fetal fraction in 61 samples collected from singleton pregnancies in Vancouver over a two month period. Each pregnancy had two 10mL peripheral blood samples taken; one in EDTA and one Streck. Samples from EDTA tubes with size selection had no failures, and an average fetal fraction of 13%; a significant increase compared to Streck tubes (7%). They concluded that the addition of this size-selection step is ‘a strategy that significantly increases fetal fraction and reduces the number of no-call results due to low fetal fraction…[this is] a cost-saving measure for the laboratory and benefits women’ (1). In doing so, they demonstrated that Ranger® Technology offers an alternative solution to the use of Streck BCTs for stabilising NIPT samples. Dr François Rousseau from the Université Laval presented this work at the Labroots 2022 Genetics Virtual Week event, and you can watch an on demand recording.
Yourgene Health have now made this capability accessible to the market exclusively via the LightBench® Detect. Ranger® Technology is the only size-selection methodology capable of offering this flexibility in BCT choice.
The LightBench® Detect is currently the only instrument in the Ranger® portfolio capable of leveraging the patent-pending EDTA size selection approach tested by the Laval group. Yourgene Health have conducted extensive analysis in collaboration with our clinical laboratory partners to understand both the potential clinical and economic benefits that could be achieved in adopting the LightBench® Detect. You can read the results of this analysis in our Your Expert article on cost savings here.
At this time, the development will only be accessible to Yourgene’s non-IONA® Nx NIPT customers, including Sage™ 32plex, as the feature is not yet available on the QS250. The Yourgene® QS250 is optimised for use in Yourgene’s end-to-end NIPT workflow offerings. This decision is part of Yourgene’s recently announced commitment to a next-generation approach to delivery of NIPT testing solutions, with a focus on ‘Collaboration to Perform’. Working as a partnership, rather than the traditional laboratory/manufacturer relationship, represents a shared commitment to ensuring high-quality and performance-driven testing, ultimately delivering better outcomes for patients. For these reasons, we are first collaborating with a subset of IONA® Nx customers to collect robust validation data to support the proper utilisation of this development within the QS250 i.e. a CE-IVD environment. We anticipate these validation studies will be completed within 2022, at which time we will begin development within the IONA® workflow.
Liquid Biopsy in the Clinic
The LightBench® Detect is the optimal choice for laboratories looking to translate their oncology liquid biopsy workflows into routine clinical practice. You can find out more about how Ranger® Technology can help address the challenges of tumor specific variant profiling in cancer patients by watching this on demand webinar, featuring Kimberly Holden, Research Associate in Oncology Diagnostics Assay Development at Labcorp.
Reference: 2022. Improving fetal fraction in NIPT by size selection of samples collected in EDTA gel tubes [Poster]. ISPD (26th International Conference on Prenatal Diagnosis and Therapy), 20-22 June 2022, Stand 205.