A joint announcement of the Genetics & Public Policy Center and the Coalition fo

[Guest guest]

A joint announcement of the Genetics & Public Policy Center and the Coalition

for 21st Century Medicine

To " get personalized medicine right, " Health and Human Services (HHS) Secretary

Sebelius will need to " create and implement a reasonable and responsible

regulatory framework " for genetic tests and other advanced medical diagnostics,

a diverse coalition of more than a hundred organizations representing genetic

testing laboratories, patient advocates, investors, and health policy

researchers said today.

In a letter to the newly confirmed Secretary, the group noted that while

accurate, reliable, and timely genetic testing offers enormous promise to help

shape our healthcare system to meet the challenges of the 21st century, " poor

quality testing can harm patients and waste scarce resources. " Physicians

already are using genetic tests - currently available clinically for some 1,500

diseases or conditions - to diagnose disease, to predict an individual patient's

risk of future disease, and to guide decision making about further diagnostic

procedures and choices among therapeutic options. " Advanced diagnostic testing

is becoming the standard of care for many diseases, " the group told Sebelius.

Regulatory oversight of genetic testing needs to " strike the right balance

between assuring patient safety and embracing policies that encourage the

incorporation of rapidly advancing scientific methods and knowledge, " the group

wrote. Moreover, " it is essential that new regulatory oversight policies be

clearly stated and publicly vetted before they are implemented, " they said.

The new regulatory framework should " put patients first, be grounded in science,

appropriately incentivize innovation, and be fully consistent with established

statutes, " the group counseled. Its letter outlines three goals Secretary

Sebelius should adopt in crafting a framework of genetic testing oversight:

All advanced diagnostic tests - including both test kits and genetic tests

developed in-house by the laboratory, which currently are subject to different

levels of regulatory scrutiny under Food and Drug Administration (FDA) policies

- should be regulated using consistent risk-based standards recognizing the

unique aspects of each. Scientific capabilities at HHS and FDA may need to be

enhanced and strengthened to accomplish this, the group notes.

Sebelius should establish a publicly accessible registry that includes the name

of laboratory performing a specific test, the name of the laboratory or company

that developed the test, and information to support claims about the how useful

the test is in obtaining the correct results and improving clinical care.

Oversight of clinical laboratory quality, currently tasked to the Centers for

Medicare and Medicaid Services (CMS), should be strengthened to make sure that

the information provided by genetic and other advanced diagnostic tests is

accurate, reliable, and timely. FDA and CMS need to review their respective

oversight roles to avoid unnecessary duplication, the letter advises.

The letter is remarkable for the breadth of its 108 signatories, according to

Kathy Hudson, director of the Genetics & Public Policy Center at s Hopkins

University, which has signed the document. " Many of us are more accustomed to

being on opposite sides of the table when it comes to regulating genetic

testing, " she says. " The level of consensus here truly represents a watershed

moment in laying this critical foundation for personalized medicine. "

" The importance of this issue to patients is clear from the large number of

patient advocacy groups who signed onto this letter, " said Sharon Terry. Terry

is the chief executive officer of the Genetic Alliance and a board member of the

Coalition for 21st Century Medicine, both of which signed the document.

The letter is available at

http://www.dnapolicy.org/resources/LtrtoSecSebeliusrePersonalizedMedicine.pdf

About the Genetics and Public Policy Center

The Genetics and Public Policy Center at s Hopkins University is a trusted

source of information about, and analysis of, public policy related to human

genetics. The Center is supported by The Pew Charitable Trusts, with research

funding from the National Human Genome Research Institute and Eli Lilly and

Company.

About the Coalition for 21st Century Medicine

The Coalition for 21st Century Medicine represents some of the world's most

innovative diagnostic technology companies, clinical laboratories, researchers,

physicians, venture capitalists and patient advocacy groups - all linked by a

common mission to develop advanced diagnostics that improve the quality of

healthcare for patients. For more information about the Coalition for 21st

Century Medicine please visit www.twentyfirstcenturymedicine.org.