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Dental Association Advances Resolution on Genetic Test Validity

NEW YORK (GenomeWeb) – Insurers that want to use genetic testing to determine members' eligibility for insurance coverage should publish data showing these tests are scientifically valid and be transparent about conflicts of interest, according to a resolution approved by the American Dental Association's House of Delegates.

The resolution, which the ADA's House of Delegates passed this week without objection, asks insurers and test manufacturers that want to use genetic testing to determine coverage eligibility to establish and confirm the test's validity and reliability through a third-party agency, and publish how the plan design will impact costs and patient outcomes. They should also disclose financial relationships and conflicts of interest between the test manufacturer, payor, and study investigators.

The resolution came about after ADA members became increasingly concerned over the promotion of Delta Dental of Michigan's RightSize plan, which used Interleukin Genetics' PerioPredict (later called Ilustra) genetic test to determine the number of covered cleanings its members could get. Under the plan, Delta Dental employees would get one covered cleaning annually unless they were determined by PerioPredict to be at high risk for gum disease or if they had clinical risk factors such as diabetes or a history of periodontal care.

Using this genetics-based plan design, a University of Michigan study showed that insurers could save around $37 per patient. This study, which Interleukin used to promote the clinical utility of its gum disease risk test, was led by Interleukin Founder Kenneth Kornman and University of Michigan's William Giannobile, and published in the Journal of Dental Research.

Giannobile is editor-in-chief of that journal. Moreover, Delta Dental Plan of Michigan invested $3 million into Interleukin in 2012 and held a seat on the company's board of directors until 2014. The insurer is an affiliate of Renaissance Health Services Corporation, which funded the University of Michigan study.

In a July article, GenomeWeb chronicled these and other conflicts, as well as the dental community's growing concerns about the test's scientific validity after debt-ridden Interleukin decided to stop marketing the test, liquidate its assets, and lay off staff. A number of experts told GenomeWeb that Interleukin's test should have never come to market in the first place, but remained available to patients for years because the company's leaders had influence within the dental research community, a group that is not well-enough versed in genetics to be able to parse the available data themselves.

The ADA cited this article in advancing the resolution. According to the ADA, the current resolution sets out its initial expectations on this topic, but the association will also work with the American National Standards Institute to advance specific standards that genetic tests should meet before being used in benefit plans.