Center calls for stronger federal regulation of genetic testing

(WASHINGTON, Nov. 29, 2005) 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 la

Contact: Rick Borchelt
Genetics & Public Policy Center, Johns Hopkins University

Page: 1 2

Related biology news :

1. Psychiatric Genomics Center established at Cold Spring Harbor Laboratory
2. Energy department selects 3 Bioenergy Research Centers for $375 million in federal funding
3. Woods Hole Research Center scientists study impacts of industrial logging in Central Africa
4. Innovative smallpox vaccine research study to be conducted at Case Medical Center
5. CSHL selected for odENCODE Data Coordination Center
6. Woods Hole Research Center scientists using remote sensing tools to predict bird species richness
7. NYUs Center for Comparative Functional Genomics part of $57 million MOD-ENCODE consortium
8. Understanding the global carbon budget -- Woods Hole Research Center expert provides insights
9. NIH establishes Center of Excellence for influenza research at Mount Sinai
10. St. Jude named a Center of Excellence in flu research
11. New Geisinger Health System building green Center for Health Research

Post Your Comments:

(Date:4/15/2016)... Research and Markets has announced ... 2016-2020,"  report to their offering.  , ... global gait biometrics market is expected to grow ... 2016-2020. Gait analysis generates multiple variables ... to compute factors that are not or cannot ...
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys ... founding CEO, Barrett Bready , M.D., who returned ... of the original technical leadership team, including Chief Technology ... of Product Development, Steve Nurnberg and Vice President of ... to the company. Dr. Bready served as ...
(Date:3/22/2016)... , PROVO and ... Newborn Screening Ontario (NSO), which operates the highest sample ... molecular testing, and Tute Genomics and UNIConnect, leaders in ... respectively, today announced the launch of a project to ... (NGS) testing panel. NSO has been ...
Breaking Biology News(10 mins):
(Date:6/24/2016)... June 24, 2016  Regular discussions on a range of ... between the two entities said Poloz. Speaking at ... Ottawa , he pointed to the country,s inflation target, ... government. "In certain ... institutions have common economic goals, why not sit down and ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... is pleased to announce the launch of their brand, UP4™ Probiotics, into Target ... over 35 years, is proud to add Target to its list of well-respected ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm ... Mold) microbial test has received AOAC Research Institute approval 061601. , “This is ... last year,” stated Bob Salter, Vice President of Regulatory and Industrial Affairs. “The ...
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample ... the Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. ... said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our capacity ...
Breaking Biology Technology:
Cached News: