Final clinical study results

presented at the 2016 annual meeting of the Quebec Association of Gastroenterologists (AGEQ)

 

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. 1081 subjects >40 years of age who underwent colonoscopy were recruited between October 2014 and January 2016. NK Vue™, 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.

Final study results were presented on November 19, 2016 during the annual meeting of the Quebec association of gastroenterologists (AGEQ) by Dr. Gilles Jobin, chief of gastroenterology, Maisonneuve-Rosemont Hospital, Montreal.

 

Clinical study results

Briefly, in the 872 evaluable subjects, statistically significant differences were found between the NKA of patients positive for CRC (n=23), confirmed by colonoscopy and pathological verification, and that of patients negative for CRC (n=849) (CRC mean 317.2 pg/mL, CRC-negative mean 745.7 pg/mL, p=0.0002; CRC median 86.0 pg/mL, CRC-negative median 298.1 pg/mL, p=0.0002). At a cut-off of 200 pg/mL, sensitivity of the IVDD for the detection of CRC was 87.0%, with a specificity of 60.7%, with positive and negative predictive values of 5.7% and 99.4%, respectively. Subjects with NKA values under 200 pg/mL were 10.3 times more likely to have CRC compared to other subjects.

The present study using a new simple blood test confirms that the measurement of 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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