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VolitionRX's Preliminary Diagnostic Clinical Trial Results Show High Sensitivity and Specificity for Colon, Breast and Lung Cancers


11/5/2012 10:47:51 AM

SINGAPORE, Nov. 5, 2012 /PRNewswire/ -- VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests, today announced preliminary findings from its ongoing internal clinical trials of the NuQ® diagnostic platform. VolitionRx has analysed blood samples from 105 patients and was able to detect 76% of the patients with colon cancer, 96% of those with breast cancer, and 100% of patients with lung cancer.

Of the 105 patients tested, 74 had cancer (25 colon cancer, 25 breast cancer and 24 lung cancer), and 31 were healthy (not diagnosed with cancer). Volition tested all the patient samples for elevated nucleosome structures using one of its NuQ kits, with the following results for colon, breast and lung cancer:

  • 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).

Further clinical results will be announced as they become available.

As announced in July, VolitionRx is currently moving through an independent 800-patient (expanded from the initial 400 patients) retrospective study on multiple cancer types, which is being carried out at Rheinische Friedrich-Wilhelms-Universitat Bonn and is expected to be completed by the end of this year. Preliminary results from this study based on 62 healthy subjects, 20 patients with benign colon tumors and 35 patients with colorectal cancer are consistent with VolitionRx internal results and indicate that Nucleosomics tests appear to differentiate cancer patients from patients with benign colon tumors as well as healthy patients.

Dr. Jake Micallef, Chief Scientific Officer for Belgian Volition, said: "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."

Priv.-Doz. Dr Stefan Holdenrieder of Rheinische Friedrich-Wilhelms-Universitat Bonn, coordinator of the external trials, said: "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."

Full data from both studies will be published in a peer-reviewed journal when the studies are complete.

Note on Preliminary Data
A test result is considered positive when above the normal range calculated by the standard diagnostic method (mean +/- 2 standard deviations of the mean).

About VolitionRx
VolitionRx is a life sciences company whose goal is to make its non-invasive blood tests for cancer as common and simple to use as existing diabetic and cholesterol tests on similar formats.

VolitionRx's development activities are currently centered in Belgium with a focus on bringing its revolutionary diagnostic products to market first in Europe, then the U.S. and worldwide.

You can find more information about VolitionRx at our website at www.volitionrx.com, on Twitter at www.twitter.com/VolitionRx, LinkedIn at www.linkedin.com/company/1364072?trk=tyah or Facebook at www.facebook.com/volitionrx.

Safe Harbor Statement
Statements in this press release may be "forward-looking statements". Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "optimizing," "potential," "goal," and similar expressions, as they relate to the Company, its business or management, identify forward-looking statements. These statements are based on current expectations, estimates and projections about the Company'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. Actual outcomes and results may, and probably will, differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors, including those described above and those risks discussed from time to time in the Company's filings with the Securities and Exchange Commission.

SOURCE VolitionRx Limited


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