TEST:

RaDaR™ assay

We assessed ctDNA with the RaDaR assay in NeoRHEA (NCT03065621), a single-arm, phase II neoadjuvant palbociclib plus endocrine therapy trial over 4 months (4 × 28-day cycles)...Baseline ctDNA predicted poor response to this regimen, supporting ctDNA as a biomarker to guide treatment in HR + /HER2-negative disease. Trial registration: EU Clinical Trials Register (EudraCT 2016-000879-24; registered 15 February 2017).

"NeoGenomics...will present new research at the International Society of Liquid Biopsy (ISLB) Annual Congress 2025 demonstrating high concordance between its RaDaR® ST and RaDaR® 1.0 assays for detecting molecular residual disease (MRD) in solid tumors. NeoGenomics will also present on the progress of its NextGen (whole genome-based) MRD research program, as well as three additional posters highlighting the company’s work in liquid biopsy and genomic profiling across solid tumor types."

For the rarest conditions, international collaboration remains essential to achieve adequately powered datasets and harmonised endpoints. RaDaR demonstrates how a national registry can bridge the gap between real-world data and therapeutic development, accelerating the path from disease understanding to drug approval in rare kidney disease.

"NeoGenomics...today announced the presentation of assay-relevant data, including interventional therapy trials in progress, to showcase how its molecular residual disease (MRD) assay may benefit pharmaceutical partners at the European Society for Medical Oncology (ESMO) Congress 2025, October 17–21, in Berlin, Germany. RaDaR ST, the company’s circulating tumor DNA (ctDNA) assay, is designed to accelerate and optimize oncology drug development."

"Natera, Inc...today provided an update regarding its intellectual property litigation with NeoGenomics, Inc...The U.S. District Court for the Middle District of North Carolina issued a ruling invalidating certain claims in two patents that Natera asserted against NeoGenomics’ v1.1 RaDaR test. Natera is evaluating its options, including an appeal and further enforcement with other patents."

Early increases in ctDNA levels correlated with disease progression. Our findings suggest that ctDNA negativity, regardless of PD-L1 expression, ICB regimen, or line of therapy, is a strong predictor of favorable outcomes in R/M HNSCC.

Overall, proteinuria a short time after diagnosis is strongly associated with long-term outcomes and a UPCR under 100 mg/mmol at one year is associated with a substantially lower kidney failure risk.

Significantly, the bacterial RADAR assay described here requires no large, expensive lab equipment, thus making it accessible to most laboratories. Furthermore, it does not require any long centrifugation steps, which allows for a relatively large number of samples to be processed in 1 day.

Kidney outcomes were poor in genetic nephrotic syndrome; in FSGS outcomes were strongly associated with proteinuria level. Minimal change disease patients had better proteinuria control than FSGS and had better outcomes at each proteinuria level.

Regional variations in rate of genetic testing appeared to be driven by economic factors. However, large differences in rate of active screening were not correlated to healthcare spending and probably reflect the influence of different of cultural, legal and ethical frameworks on families and clinicians in different healthcare systems.

A power analysis was carried out for the REACTIV assay, demonstrating that ignoring the dependency structure potentially leads to lower power and an increased false positive rate in comparison to the mixed ANOVA approach. The open-source R-package "xeredar" also comes with a Shiny app, making it accessible to everyone and thereby enhancing standardization and reproducibility for the statistical analyses of XETA, RADAR, and REACTIV assays.

The machine learning model predicted disease progression with 88% accuracy (AUC 0.89). Serial ctDNA monitoring predicted disease control, survival, and progression in patients with R/M HNSCC receiving treatment with ICB, suggesting that incorporation of ctDNA into clinical practice could enhance treatment decision-making for clinicians and improve patient outcomes.