By Brian Marckx, CFA
This morning (8/6/12) Interleukin Genetics (OTC Markets:ILIU) announced that the University of Michigan revealed top-line results of the eagerly awaited PST test study. The top-line data is positive, in favor of Interleukin's PST study showing efficacy on the primary endpoint, change in tooth loss based on patient risk category.
The study, officially titled Periodontal Disease Prevention Study: A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease was funded by Renaissance Health Service and conducted by the University of Michigan. It examined 16 years worth of data from over 5,000 patients taken from a large dental claims database. It is the pivotal study which is expected to show that certain risk factors, including a positive result on ILIU's PST genotyping test, can help predict periodontal disease and determine the optimal number of dental cleanings per year, which will provide support to reimburse for the PST from dental insurance providers.
Top-line data from the study showed exactly what Interleukin hoped, that high risk patients are likely to benefit from more than one cleaning per year while low risk patients are not. Specifically the data showed that there was no significant difference between two dental cleanings and one dental cleaning in reducing the number of tooth extractions in the low-risk patient population (13.8% vs. 16.4%, p=0.092). By contrast there was a highly significant difference between two dental cleanings and one dental cleaning in reducing the number of tooth extractions in the high-risk patient population (16.9% vs. 22.1%, p=0.002).
Per the trial protocol, patients were categorized as low risk of tooth loss if they were non-smokers, did not have diabetes and were PST test negative. High risk were smokers, diabetic and PST test positive. Of particular interest is that the top-line data also shows a highly significant (p<0.001) correlation between the number of positive risk factors and extractions - implying that all risk factors (i.e. - including PST) are indicative of risk of tooth loss.
The full data set is expected to be submitted for publication by the UofM. Following publication, we expect that Interleukin's game plan will continue to be to roll out their PST test supported with dental insurance reimbursement from Renaissance Health/Delta Dental which touches as many as 54 million covered lives.
This top-line data, along with the early July news that Delta Dental injected $3 million in new financing to ILIU provides what we view as substantial support for the potential of ILIU's PST test.
We cover Interleukin Genetics with an Outperform rating and a $1.30 price target. Please visit scr.zacks.com for a free copy of the ILIU research report.