HOME >> BIOLOGY >> NEWS
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
rborche1@jhu.edu
202-663-5978
Genetics & Public Policy Center, Johns Hopkins University
29-Nov-2005


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:
*Name:
*Comment:
*Email:


(Date:6/22/2016)... June 22, 2016   Acuant , ... verification solutions, has partnered with RightCrowd ® ... for Visitor Management, Self-Service Kiosks and Continuous ... that add functional enhancements to existing physical ... and venues with an automated ID verification ...
(Date:6/16/2016)... FRANCISCO , June 16, 2016 ... size is expected to reach USD 1.83 ... by Grand View Research, Inc. Technological proliferation and ... banking applications are expected to drive the market ... ) , The development of advanced ...
(Date:6/7/2016)... 7, 2016  Syngrafii Inc. and San Antonio ... that includes integrating Syngrafii,s patented LongPen™ eSignature "Wet" ... collaboration will result in greater convenience for SACU ... while maintaining existing document workflow and compliance requirements. ... Highlights: ...
Breaking Biology News(10 mins):
(Date:6/23/2016)... On Wednesday, June 22, 2016, the ... the Dow Jones Industrial Average edged 0.27% lower to finish ... 0.17%. Stock-Callers.com has initiated coverage on the following equities: Infinity ... NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ... ). Learn more about these stocks by accessing their free ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... regulatory and technical consulting, provides a free webinar on Performing Quality ... 13, 2016 at 12pm CT at no charge. , Incomplete investigations are still ...
(Date:6/23/2016)... , June 22, 2016  Amgen (NASDAQ: ... of the QB3@953 life sciences incubator to ... health. The shared laboratory space at QB3@953 was created ... a key obstacle for many early stage organizations - ... of the sponsorship, Amgen launched two "Amgen Golden Ticket" ...
(Date:6/22/2016)... , June 22, 2016 Cell ... will allow them to produce up to one ... one lot within one week. These high-quality, consistent ... laboriously preparing cells and spend more time doing ... through a proprietary, high-volume manufacturing process that produces ...
Breaking Biology Technology:
Cached News: