Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Center calls for stronger federal regulation of genetic testing

30.11.2005


Requests agency to issue proposed regulation to assure quality of genetic tests



The Genetics and Public Policy Center this week called on Mark McClellan, Administrator of the Centers for Medicare and Medicaid Services (CMS), to end years of delay in assuring the safety and accuracy of genetic testing by issuing a proposed rule to create a genetic testing specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The delay has meant that scientific and technological advances in genetic testing have outpaced the government’s ability to provide adequate oversight, maintains the Center, which was established by The Pew Charitable Trusts through Johns Hopkins University.

CMS, an agency of the U.S. Department of Health and Human Services, administers standards for diagnostic laboratory testing, such as those used for blood sugar, urinalysis, or HIV infection, to ensure that the tests are accurate and reliable and that physical conditions at the laboratories meet certain expectations.


"For more than ten years, federal advisory committees have been calling upon the government to provide more oversight of genetic tests," the letter to McClellan from the Center notes. CMS responded to the growing sense of urgency to improve genetic testing oversight five years ago by issuing a Notice of Intent of proposed rulemaking that incorporated recommendations from a federal advisory group regarding development of a genetic testing specialty.

"More than five years later, nothing has been issued by (CMS)," the letter says. During the same period, the genetic testing industry has grown dramatically; today, more than 800 genetics tests are available clinically, and many more are in development. "These genetic tests may be the basis for profound life decisions, such as whether to undergo prophylactic mastectomy, terminate a pregnancy, or take a certain drug or certain dosage of a drug," according to the letter.

Under CLIA, CMS is charged with developing standards for how medical laboratory tests are conducted, the training and proficiency of laboratory personnel, and other standards to ensure the quality of clinical tests. The problem, says Center policy analyst Gail Javitt, an author of the letter, is that CLIA did not include a genetic testing specialty for the then-nascent field of genetic testing as part of its oversight regime.

"The absence of a specialty area for genetic testing with specifically tailored requirements for the now-burgeoning genetic testing industry hampers CLIA’s ability to oversee the quality of genetic testing and adequately to ensure its safety," she writes. "We urge CMS to take immediate steps to issue proposed regulations for a genetic testing specialty."

The Center reviewed all the comments that were collected by CMS five years ago in response to the Notice of Intent, Javitt explains. "There were no showstoppers here in terms of issues central to the regulation," she says. "Rather, we found substantial support for the creation of a genetic testing specialty." There were specific concerns about a few of the proposed requirements detailed in the Notice of Intent, she explained, but these that could be left out of the final rule without unduly weakening the regulation. "A genetic testing specialty is achievable if it focuses on key quality requirements such as analytic and clinical validity of the tests and proficiency standards for laboratory personnel," she added.

"The government has been dragging its feet for more than 10 years about improving the quality of genetic testing," she said. "It’s time to move swiftly to protect the American public and publish a proposed rule."

Rick Borchelt | EurekAlert!
Further information:
http://www.jhu.edu
http://www.dnapolicy.org/policy/regulations/McClellanletter.pdf
http://www.dnapolicy.org/

More articles from Life Sciences:

nachricht Cancer diagnosis: no more needles?
25.05.2018 | Christian-Albrechts-Universität zu Kiel

nachricht Less is more? Gene switch for healthy aging found
25.05.2018 | Leibniz-Institut für Alternsforschung - Fritz-Lipmann-Institut e.V. (FLI)

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Powerful IT security for the car of the future – research alliance develops new approaches

The more electronics steer, accelerate and brake cars, the more important it is to protect them against cyber-attacks. That is why 15 partners from industry and academia will work together over the next three years on new approaches to IT security in self-driving cars. The joint project goes by the name Security For Connected, Autonomous Cars (SecForCARs) and has funding of €7.2 million from the German Federal Ministry of Education and Research. Infineon is leading the project.

Vehicles already offer diverse communication interfaces and more and more automated functions, such as distance and lane-keeping assist systems. At the same...

Im Focus: Molecular switch will facilitate the development of pioneering electro-optical devices

A research team led by physicists at the Technical University of Munich (TUM) has developed molecular nanoswitches that can be toggled between two structurally different states using an applied voltage. They can serve as the basis for a pioneering class of devices that could replace silicon-based components with organic molecules.

The development of new electronic technologies drives the incessant reduction of functional component sizes. In the context of an international collaborative...

Im Focus: LZH showcases laser material processing of tomorrow at the LASYS 2018

At the LASYS 2018, from June 5th to 7th, the Laser Zentrum Hannover e.V. (LZH) will be showcasing processes for the laser material processing of tomorrow in hall 4 at stand 4E75. With blown bomb shells the LZH will present first results of a research project on civil security.

At this year's LASYS, the LZH will exhibit light-based processes such as cutting, welding, ablation and structuring as well as additive manufacturing for...

Im Focus: Self-illuminating pixels for a new display generation

There are videos on the internet that can make one marvel at technology. For example, a smartphone is casually bent around the arm or a thin-film display is rolled in all directions and with almost every diameter. From the user's point of view, this looks fantastic. From a professional point of view, however, the question arises: Is that already possible?

At Display Week 2018, scientists from the Fraunhofer Institute for Applied Polymer Research IAP will be demonstrating today’s technological possibilities and...

Im Focus: Explanation for puzzling quantum oscillations has been found

So-called quantum many-body scars allow quantum systems to stay out of equilibrium much longer, explaining experiment | Study published in Nature Physics

Recently, researchers from Harvard and MIT succeeded in trapping a record 53 atoms and individually controlling their quantum state, realizing what is called a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

In focus: Climate adapted plants

25.05.2018 | Event News

Save the date: Forum European Neuroscience – 07-11 July 2018 in Berlin, Germany

02.05.2018 | Event News

Invitation to the upcoming "Current Topics in Bioinformatics: Big Data in Genomics and Medicine"

13.04.2018 | Event News

 
Latest News

In focus: Climate adapted plants

25.05.2018 | Event News

Flow probes from the 3D printer

25.05.2018 | Machine Engineering

Less is more? Gene switch for healthy aging found

25.05.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>