Volition Develops a New Improved Nu.Q™ Assay Format

AUSTIN, Texas, Jan. 13, 2020 /PRNewswire/ -- 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."

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.

For further details please contact [email protected].

About Volition

Volition is a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. The tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present. Volition is primarily focused on human diagnostics but also has a subsidiary focused on animal diagnostics.

Volition's research and development activities are centered in Belgium, with additional offices in Texas, London and Singapore, as the company focuses on bringing its diagnostic products to market.

For more information about Volition, visit Volition's website (http://www.volitionrx.com) or connect with us via:

Twitter: https://twitter.com/volitionrx
LinkedIn: https://www.linkedin.com/company/volitionrx
Facebook: https://www.facebook.com/VolitionRx/
YouTube: https://www.youtube.com/user/VolitionRx

The contents found at Volition's website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document. The addresses for Volition's website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.

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Safe Harbor Statement

Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of Volition's blood-based diagnostic tests as well as Volition's ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition's failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD or the veterinary market; a failure by the marketplace to accept the products in Volition's development pipeline or any other diagnostic products Volition might develop; Volition's failure to secure adequate intellectual property protection; Volition will face fierce competition and Volition's intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics™ and Nu.Q™ and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to "$" refer to the legal currency of the United States of America.

SOURCE VolitionRx Ltd

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http://www.volitionrx.com

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