XIFIN Blog

It seems that 2012 may well be the year of the registry. Last fall, Palmetto GBA announced its new MolDx program which includes a molecular test registry that addresses inconsitencies in code-stacking. At the same time the National Institutes of Health (NIH) were developing, with input from stakeholders, a Genetic Testing Registry (GTR). This Dark Daily newsletter quoted an Association for Molecular Pathology (AMP) letter that stated AMP "continues to have concerns regarding the format and the data elements proposed for the Genetic Test Registry" We have previously reported the concerns of molecular labs regarding the MolDx program.

The Dark article points out a key difference between these two registries; NIH issued this Request for Information (RFI) and sought "wide interest and participation from researchers, test developers, and manufacturers." while developing the GTR. Despite the concerns voiced by AMP, it is in the interest of labs and other entities across the health delivery spectrum to have a definitive database of both genetic tests and molecular assays currently in use.

While the lab industry had been actively seeking a solution for the provision of some type of national registry for molecular testing by an independent source, since its conception the NIH registry was embraced as the ideal vehicle primarily because of the non-threatening involvement of NIH. Since NIH’s announcement of its intent to develop the registry, it has sought stakeholder comment and involvement to establish a product that would address the needs of the community; and stakeholders have provided thoughtful and productive input. It is this level of cooperative effort that provides a balance between needed public transparency and secure disclosure of sensitive, if not proprietary, information. With so much progress already made on the development of a national registry that conceptually has the buy in of and participation from stakeholders, it would seem more productive to make sure that a single registry could accommodate the contemplated uses of both in order to allow a streamlining of efforts that is consistent with the Administrative Simplification Act. It should be the intent of all parties and the role of technology to provide the most efficient and effective solution to a defined problem.