VolitionRx Limited (NYSEAMERICAN:VNRX) has developed a new Nu.Q magnetic particle-based assay format, which offers a higher grade of analytical sensitivity.
As a result of this re-engineering and transition from a microtiter plate format, Volition now expects to see improved clinical performance in the studies it will carry out in the coming months.
The Belgian company has developed easy-to-use blood-based cancer tests, which accurately diagnose a range of cancers. The diagnostic tests are based on the science of nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluids to get an indication that a disease is present.
When compared to Volition’s ELISA plate Nu.Q assay format, the company's new magnetic particle-based assay format shows a 10 to 20-fold improvement in analytical sensitivity. It also shrinks the turnaround time of test results to one hour and 20 minutes from six hours.
“I am incredibly proud of the effort the whole team has made in the assay development program over the last two years,” said Dr. Gaetan Michel, CEO of Belgian Volition.
“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.”
On top of its other achievements, the magnetic particle-based assay format can also be developed and processed on Random-Access platforms, which permits the use of a wide range of commercial automated platforms.
Volition previously developed synthetic nucleosomes with its partners but has now brought this work in-house with its recent acquisition of Octamer, GMbh, which was announced this month.
Offering another improvement in assay sensitivity as well as extending the usable range of the assays is Volition’s move from a tradition colorimetric endpoint format to a chemiluminescent endpoint.
“The combination of a chemiluminescent endpoint with a magnetic particle-based assay format [has] greatly improved the specificity of Nu.Q assays,” the company said.
In other news, Volition has decreased assay processing time and increased the reliability of assay results by moving onto an FDA-approved automated immunoassay analyzer, which is currently in clinical use across the US and Europe.