International molecular diagnostics group Yourgene Health has launched LightBench Detect, a new addition to its Ranger Technology instrumentation portfolio which aims to help NIPT providers reduce no-call rates by optimizing average fetal fraction.
The company has worked closely with its clinical lab partners to develop size selection methodologies optimized for improving the performance of liquid biopsy workflows, most notably non-invasive prenatal testing (NIPT). Leveraging the size selection capabilities of Ranger Technology, the LightBench Detect also enables laboratories to consider the use of EDTA blood collection tubes (BCTs) instead of expensive specialized preservation blood collection tubes (BCT) in their workflows to help reduce overall costs.
The LightBench Detect is a clinical-grade 3-in-1 electrophoretic instrument offering liquid biopsy and NIPT laboratories the ability to automate the process of DNA size selection and enrichment from samples stored for prolonged periods in EDTA BCTs. This core capability is complemented by the ability to perform fragment length analysis and fluorescence assays for quality control purposes.
Cell free DNA (cfDNA) fragments of fetal origin are typically <150bp in length, meaning size selection using the instrument can enrich for fetal fraction to reduce the number of no-call results or screening failures, helping improve overall patient outcomes. Use of the technology in NIPT offers scalable and precise DNA size selection and achieves >97% reproducibility, ensuring consistent enrichment of the fetal fraction.
The use of this patent-pending, EDTA-enabling, technology will be presented by the Centre de recherche du CHU de Québec-Université Laval. The group worked with Yourgene to compare fetal fraction in 61 samples collected from singleton pregnancies in Vancouver over a two-month period. Samples stored in the expensive BCTs had fetal fractions below 4% (a common pass/fail threshold) 12% of the time, while samples stored in inexpensive EDTA tubes had zero cases of fetal fraction below 4% when paired with size selection.
A low fetal fraction in NIPT will result in a no result and potentially a re-draw blood sample from the pregnant mother. They demonstrated that Ranger Technology offers an alternative solution to the use of expensive BCTs for stabilising NIPT samples. Yourgene has now made this capability accessible to the market via the LightBench Detect.
“Every once in a while, a technology comes along that has the potential to disrupt standard clinical testing workflows and make real improvements, both to the test performance and the economics and efficiencies of a test,” says Lyn Rees, CEO of Yourgene Health. “Working with Université Laval has enabled us to deliver the LightBench Detect, which radically improves efficiencies by giving labs flexibility of choice around the blood collection tube they use without impacting performance. We are so excited to roll out this capability to other NIPT providers.”
LightBench detect was officially unveiled at the 26th International Conference on Prenatal Diagnosis and Therapy (ISPD).