Volition presents study data at ASCO GI 2022 on circulating nucleosomes for the detection of colorectal cancer and high-risk advanced adenomas

AUSTIN, Texas, Jan. 20, 2022 /PRNewswire/ --VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, has announced the results of two large scale clinical studies, which show that the company's Nu.Q® assays, when used in conjunction with the Fecal Immunochemical Test (FIT), can detect colorectal cancer and all high-risk advanced adenomas in symptomatic patients, and thereby reduce unnecessary colonoscopies. The studies also demonstrated that the company's Nu.Q® assays can improve the detection of high-risk adenomas in asymptomatic patients.

Principal Investigator, Professor Han-Mo Chiu, National Taiwan University, said "We are enormously encouraged by the findings of these two studies. Not only do they show that using Nu.Q® assays in combination with FIT can potentially reduce unnecessary colonoscopies by up to 28% in patients with gastrointestinal symptoms, the studies also show that this dual approach could be used more widely to improve the effectiveness of FIT-based screening programs targeting asymptomatic patients. We look forward to presenting our findings to colleagues at ASCO GI 2022."

Dr. Marielle Herzog, Research and Development Director at Volition, said "Early diagnosis is key to improving outcomes for patients with colorectal cancer, and cancer screening programs are critical to every public health system. The results of our studies, using Volition's Nu.Q® assays in conjunction with FIT, are incredibly encouraging, not only in reducing unnecessary colonoscopies but also in detecting high-risk adenomas, both proximal and distal, which FIT, when used alone can miss. We are excited about the next stage, facilitating an independent, prospective validation study later this year."

The studies were undertaken by Volition and the Department of Internal Medicine at the National Taiwan University Hospital and findings will be presented at the 2022 ASCO Gastrointestinal Cancers Symposium, later this week.

Volition is developing simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including cancer.

Colorectal cancer is the fourth most common cancer worldwide, with 1.9 million new cases in 2020, and accounts for over 9% of all cancer-related deaths each year¹. Population-based colorectal cancer screening programs are in place in many healthcare systems globally, and the most commonly recommended screening method² is the FIT, followed up with colonoscopy, an invasive visual examination. However, approximately 60% of FITs provide false-positive results³, leading to unnecessary and costly colonoscopies.

Posters to be presented at ASCO GI 2022 can be downloaded here:

1) Circulating nucleosomes levels improve FIT performance for detecting high-risk colorectal neoplasms in a symptomatic population.
2) Circulating nucleosomes for detection of colorectal cancer and high-risk advanced adenomas.

For more information about Volition's Nu.Q® technology go to: www.volition.com

Notes to editors:

References:

¹ World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2020: estimated cancer incidence, mortality and prevalence worldwide in 2020.

² Schliemann, D., Ramanathan, K., Matovu, N. et al. The implementation of colorectal cancer screening interventions in low-and middle-income countries: a scoping review. BMC Cancer 21, 1125 (2021).

³ Chiu HM, Chen SL, Yen AM, et al. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer. 2015;121(18):3221-3229.

About the studies

• 476 patients referred for surveillance colonoscopy or secondary to bowel symptom were enrolled: (i) CRC (n= 67), (ii) advanced adenoma (AA) (n=60), non-AA (n=123); (iv) non-neoplastic polyps (n=29); (vi) colonoscopy negative (controls) (n=197).
• 520 average-risk asymptomatic patients: (i) CRC (n= 33), (ii) advanced adenoma (AA) (n=123, including 18 with AA>2cm); (iii) non-AA (n=168); (iv) non-neoplastic polyps (n=30); (vi) colonoscopy negative control (n=166).
• Plasma and stool samples were obtained prior to colonoscopy.
• Circulating Nucleosome levels measured using Volition's Nu.Q® quantitative immuno-assays.
• FIT: OC-SENSOR (Eiken Chemical Co., Ltd., Tokyo, Japan) using a positive cut-off of 20ug/g feces.

About Volition

Volition is a multi-national epigenetics company that applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy to use, cost effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19. Early diagnosis and monitoring have 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 and monitoring but also has a subsidiary focused on animal diagnostics and monitoring.

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

For more information about Volition, visit Volition's website volition.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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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.

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