Late-breaking clinical study results

presented at DIGESTIVE DISEASE WEEK (DDW) 2016

 

A new blood test to assess the risk of Colorectal Cancer (CRC)
Measurement of Natural Killer Cell Activity (NKA) in patients undergoing colonoscopy.

 

Clinical study details

This study was conducted at Maisonneuve-Rosemont Hospital in Montreal, Quebec, Canada by Dr. Gilles Jobin and colleagues. 1047 successive subjects >40 years of age, who underwent colonoscopy, were recruited between October 2014 and January 2016. NK Vue TM a novel in vitro diagnostic device (IVDD), was used to measure NKA in these subjects. NKA was compared in subjects with cancer-negative colonoscopies to those with pathologically confirmed CRC.

Preliminary study results were presented May 24th at DDW 2016 by Dr. Gilles Jobin, Chief of Gastroenterology, Maisonneuve-Rosemont Hospital, Montreal. The abstract has been published in the April 2016 supplement of Gastroenterology on page S-1270.

 

Clinical study results

Briefly, in the 762 evaluable subjects, statistically significant differences were found between the NKA of patients positive for CRC (n=21), confirmed by colonoscopy and pathological verification, and that of patients negative for CRC (n=741) (CRC mean 344.2 pg/mL, CRC-negative mean 731.5 pg/mL, p=0.001; CRC median 87.0 pg/mL, CRC-negative median 294.8 pg/mL, pmL, sensitivity of the IVDD for the detection of CRC was 85.7%, with a specificity of 59.6%, with positive and negative predictive values of 5.7% and 99.3% respectively.

The present study using a new simple blood test confirms that the measurement of NK Cell Activity (NKA) may be a useful tool in clinical practice to assess the risk of CRC.

 

About NK Vue

NK Vue is the first commercially available IVDD that measures NKA in a small volume of stimulated whole blood. This IVDD was approved by Health Canada in December 2014 for the monitoring of the immune status of individuals.

 

 

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