New simple blood test measuring NK Cell activity predicted the presence of colorectal cancer and may help existing screening strategies

 

Jobin G, Rodriguez-Suarez R, Betito K. Gastroenterology. 2017;153:980-987, doi:10.1053/j.gastro.2017.06.009.
Access a PDF of the published article at: http://www.gastrojournal.org/article/S0016-5085(17)35743-8/pdf

 

Study objective

Low natural killer (NK) cell activity has been linked to a higher risk of cancer, including colorectal cancer (CRC). Activity of NK cells can be measured in a small volume of whole blood by a commercially available test. This study investigated whether the test could be used to identify patients with CRC.1

 

Study details

The study was an open-label, prospective, cross-sectional study of 872 high-risk subjects (> 40 years old) screened for CRC by colonoscopy at a university hospital in Montréal, Canada, from October 2014 to January 2016. The primary objective was to determine the difference in NK cell activity between subjects with vs. without CRC. The secondary objective was the test performance, based on receiver operating characteristic (ROC) curve analysis, and cut-off value that most accurately identified individuals with CRC.1

 

Study highlights

In a population of high-risk subjects, the test for NK cell activity demonstrated:1

  • A significant difference in NK cell activity (NKA) in CRC subjects (n=23) compared to non-CRC subjects (n=849) (p=0.0002).
  • High sensitivity (87%), high negative predictive value (99.4%), moderate specificity (60.8%), and low positive predictive value (5.7%) for CRC.
  • An odds ratio > 10 (10.3, 95% CI, 3.03–34.9), suggesting subjects with an NK cell activity value < 200 pg/mL have a tenfold greater risk of CRC detection upon colonoscopy vs. subjects with values above this cut-off.

While the study was not designed to compare the performance of the FIT and NK cell activity tests, in a sub-group analysis with results for FIT (n=170):1

  • Subjects with a positive FIT and low NK cell activity (40/170), 91% of the CRC cases would have been detected by performing only 24% of the total number of colonoscopies.1

These findings suggest an important role of the NK cell activity test as a risk assessment tool for the absence of CRC since tests with high negative predictive value are best used as rule-out tests, while the high odds ratio for CRC may suggest use as a test to confirm the presence of CRC. 1

 

Study conclusions

The study findings indicate potential use of the NK cell activity test in a high-risk population as a risk assessment tool for CRC. This approach may also provide an opportunity to triage subjects on colonoscopy waiting lists and help to better manage resources. 1 Clinicaltrials.gov number: NCT02291198.

 

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 following indication: “NK Vue is intended for in vitro diagnostic use, for the monitoring of the immune status of individuals. Measurement of NK cell activity could be a useful tool for assessing changes in immunosurveillance, which, in turn, could be indicative of a condition or disease where NK cell activity has been shown to be affected.”

 

Who is ATGen

ATGen is a public immunodiagnostic company focused on the development of in vitro diagnostic devices for the analysis of patients’ immune function.

 

References:   1. Jobin G, Rodriguez-Suarez R, Betito K. Gastroenterology. 2017;153(4):980-987, doi:10.1053/j.gastro.2017.06.009.

 

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