By Kirell Lakhman

The NIH plans to create a voluntarily public Genetic Testing Registry that will be designed to "enhance transparency" of such tests and, eventually, enable researchers to develop new ones, the agency announced today.

Hoping to "enhance access to information about the availability, validity, and usefulness of genetic tests," the plan, thankfully, is a departure from a recommendation made two years ago by the HHS Secretary’s Advisory Committee for Genetics, Health, and Society to build a mandatory registry.

And NIH would be wise to ensure the registry remain voluntary. A mandatory database would shoulder the fledgling genetic-testing industry — both its private and public sectors — with an unbalanced burden of disclosure.

According to NIH, the registry aims to "encourage providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; provide an information resource for the public, including researchers, health care providers, and patients, to locate laboratories that offer particular tests; and facilitate genomic data-sharing for research and new scientific discoveries."

In a statement, NIH Director Francis Collins said the registry "will help consumers and health care providers determine the best options for genetic testing, which is becoming more and more common and accessible."

The database will reside at the agency and will be overseen by the NIH Office of the Director, according to the agency. The National Center for Biotechnology Information will be responsible for developing the registry, which is "expected to be available in 2011."

There are more than 1,600 genetic tests available to patients and consumers, according to NIH, and data about them "will be integrated with information in other NIH/NCBI genetic, scientific, and medical databases to facilitate the research process," NIH said in the statement.

As it develops the registry, NIH "will engage with stakeholders — such as genetic test developers, test kit manufacturers, health care providers, patients, and researchers — for their insights on the best way to collect and display test information." Other federal agencies, including FDA and CMS, will be "consulted."

No word yet on how much the registry would cost to build and maintain, or whether industry would play a role in financing it.

In a separate statement released today, the Genetic Alliance together with The Genetics and Public Policy Center, and The Coalition for 21st Century Medicine called the planned registry "a wonderful step forward for genetic testing and the integration of genetics into medicine." (Genetic Alliance and GenomeWeb, The Sample's parent company, share a director.)

The groups have called for a mandatory genetic testing registry for several years, and today said they "look forward to the registry becoming mandatory so that we are all apprised of the quality and availability of genetic testing across the nation.”

In their statement, the groups said a mandatory registry "would enable a forward-looking oversight system that is flexible and nuanced. It would undergird a transformed system that is open, transparent, and coordinated with all stakeholders and agencies, and that balances safety, innovation, ethical and social issues, viability, and the risks and benefits of improved health."

But there's another, smaller corner to this debate. Mandatory database would, I believe, shoulder the fledgling genetic-testing industry — both its private and public sectors — with an unbalanced burden of disclosure. Pharmaceutical companies, with their vast resources and legislative limberness, have no such requirement.

Proponents of a mandatory registry should look to the omnipresent Physicians’ Desk Reference as a guide for storing and disseminating clinical information — and peer-reviewed and FDA-regulated information at that.

The PDR, which is a voluntary repository and is available online, is distributed to all practicing US physicians. Underwritten entirely by pharmaceutical companies, it is "the primary means by which [drug] manufacturers fulfill their 'duty to warn' prescribers about drug details including safety issues, and the primary drug information source routinely cited in drug-related litigation."

In short, the reference is a way for drug makers to "publicly share information about the availability and utility of their" therapeutics tests; and "provide[s] an information resource for the public, including researchers, health care providers, and patients." Sound familiar?

The two components to be included in the genetic registry that currently have no parallel in the PDR — "a means for the public to locate labs that offer particular tests and [a way to] facilitate genomic data-sharing for research and new scientific discoveries" — is hardly a call to arms to create a mandatory database. Isn't that the sort of information that can be gleaned from peer-reviewed journals and physicians ordering genetic tests?