Volition Develops a New Improved Nu.Q™ Assay Format

VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today provided an update on its Nu Q™ Clinical Assays which use a magnetic particle-based assay format. Volition has completely re-engineered its Nu.Q™ assays leading to a step-change improvement in analytical performance. Volition expects this enhanced analytical performance to translate into improved clinical performance in the studies to be carried out and reported in the coming months.

Relative to Volition's ELISA plate Nu.Q™ assay format, the magnetic particle-based assay format demonstrates:

• A 10-20-fold improvement in analytical sensitivity of the assays.
• Typical within-day reproducibility of quantitative test results below 3% (previously <10%).
• Decrease in test result turnaround time from 6 hours to approximately 1 hour and 20 minutes, allowing much higher throughput.
• The ability to be developed and processed on fully-automated Random-Access platforms (allowing the use of a wide range of commercial automated platforms).

Commenting on the assay transfer program Dr. Gaetan Michel, Chief Executive Officer of Belgian Volition said, "I am incredibly proud of the effort the whole team has made in the assay development program over the last two years and in particular, I would like to thank Mhammed Bougoussa, our recently appointed Assay Validation Expert for his significant contribution to the project. We now plan to finalize blood plasma sample pre-analytics with these assays and are excited to utilize these automated magnetic chemiluminescent assays in our clinical studies and aim to start reporting data during this quarter, and throughout 2020."

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Volition has continued to create assets by:

• Developing recombinant nucleosomes as calibrants which provide for assay specificity and reliable quantitation. Volition developed synthetic nucleosomes with its partners but has now brought this expertise in-house with the recent acquisition of Octamer, Gmbh announced January 10.
• Internalizing key processes such as chemiluminescent antibody labeling and coating of magnetic beads. This secures our supply chain and provides flexibility to speed up our assay development work.
• Moving from a microtiter plate format to a magnetic particle-based assay format. This improves assay kinetics and hence assay sensitivity and reduces assay time and increases assay throughput.
• Moving from a traditional colorimetric endpoint format to a chemiluminescent endpoint. This further reduces background, leading to further improvements in assay sensitivity as well as greatly extending the usable range of the assays. Moreover, the combination of a chemiluminescent endpoint with a magnetic particle-based assay format greatly improved the specificity of Nu.Q™ assays.
• Moving all these improvements onto an FDA-approved automated immunoassay analyzer which is currently in clinical use across USA and Europe. This further decreases assay processing time and greatly increases the reproducibility and reliability of assay results so that the same correct result is produced for any patient sample regardless of where or when the test is done or who operates the instrument.
• Moving from blood serum to blood plasma as the test sample which reduces assay interference.

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