VolitionRx’s Ltd. (VNRX) Diagnostic Platform Confirmed to Show High Sensitivity and Specificity for Colon, Breast, and Lung Cancers

VolitionRx, a life sciences company focused on making easy-to-use blood tests, earlier today reported tremendous preliminary findings from its ongoing internal clinical trials of the NuQ® diagnostic platform. The company was able to detect 76% of the patients with colon cancer, 96% of those with breast cancer, and 100% of patients with lung cancer.

Dr. Jake Micallef, Chief Scientific Officer for Belgian Volition, stated, “Our internal results are extremely promising, and are consistent with independent data from external studies. Although these are early figures and the results will need to be validated over larger numbers of patient samples, it provides further validation that our Nucleosomics tests are effective at detecting certain types of cancers. We are reaching out to several universities to collaborate on further trials of larger numbers of several single cancers, in order to have enough data to apply for European regulatory approval.”

Of the 105 patients tested, 74 had cancer (25 colon cancer, 25 breast cancer, and 24 lung cancer), and 31 were without cancer. Volition tested all the patient samples for elevated nucleosome structures using one of its NuQ kits.

The following results were included in today’s press release:

• Colon: 76% of cancers detected (19 of 25 patients) and 90% specificity (3 false positives from 31 healthy samples)
• Breast: 96% of cancers detected (24 of 25 patients) and 90% specificity (3 false positives from 31 healthy samples)
• Lung: 100% of cancers detected (24 of 24 patients) and 79% specificity (6 false positives from 28 healthy samples).

The company told investors that further clinical results will be announced as they become available.

As previously announced, VolitionRx is currently moving through an independent 800-patient (twice the original number of patients) retrospective study on multiple cancer types, which is being carried out at Rheinische Friedrich-Wilhelms-Universitat Bonn. This study is expected to be completed sometime in the next 8 weeks. Preliminary results from this study are consistent with VolitionRx internal results and indicate that Nucleosomics tests appear to distinguish cancer patients from patients with benign colon tumors as well as healthy patients.

Priv.-Doz. Dr Stefan Holdenrieder of Rheinische Friedrich-Wilhelms-Universitat Bonn, coordinator of the external trials, commented, “I am encouraged by the data coming out of Volition’s internal trial and our study here in Bonn. Given the results we have thus far, we will begin collecting patient blood samples for the 2,000 patient prospective trial focusing on twenty prevalent cancers.”

According to Volition, full data from both studies will be published in a peer-reviewed journal when the studies are complete.

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