Navigation Links
Overhaul of Genetic and Other Advanced Diagnostic Testing Regulations Necessary for Personalized Medicine, HHS Secretary Told
Date:5/5/2009

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 the 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 and Public Policy Center at Johns 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 Med
'/>"/>

SOURCE The Coalition for 21st Century Medicine
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. U.S. Diet Needs Heart-Felt Overhaul
2. As Chairman Baucus Outlines Vision for Healthcare Reform, NACDS Emphasizes Pharmacy's Essential Role in Any Successful Overhaul
3. New survey: 82 percent of Americans think health care system needs major overhaul
4. Audio from Medialink and GlaxoSmithKline: Cleaning House ... Overhaul Your Fridge and Pantry to Lose Weight
5. Genetic risk for anxiety does not have to be destiny
6. Research Highlights Genetic Risk for Autism
7. Penn Medicine, CHOP researchers demonstrate first common genetic risk factors for autism
8. Ambry Genetics Announces Illumina CSPro Certification for GA Sequencing
9. ASHG hosts fourth annual DNA Day essay contest, supports genetics education efforts
10. MCG participating in national study to identify genetic variants in schizophrenia
11. Quest Diagnostics Discovers New Genetic Mutations Affecting Cystic Fibrosis Screening
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2015)... Philadelphia, Pennslyvania (PRWEB) April 19, 2015 ... and proved tolerable in a small group of healthy ... (UPCI), partner with UPMC CancerCenter , announced ... (AACR) Annual Meeting in Philadelphia. , The ... clinical trial, which will recruit participants at high risk ...
(Date:4/19/2015)... 2015 New court documents issued by ... that Lipitor lawsuits ( http://www.lipitorlawsuitcenter.com/ ) continue to mount ... District of South Carolina. According to the April 15th ... in the proceeding on behalf of individuals who allegedly ... the cholesterol-lowering statin. This represents an increase of 110 ...
(Date:4/19/2015)... April 19, 2015 Family and friends of ... Brains in Memory of Brad Baddeley event to honor ... Foundation. , Bowling for Brains is cheduled to take place ... Dudley Street in Lincoln, Nebraska. Participants may arrive at 12:30pm ... 3:00pm. , The cost is only $4 per game and ...
(Date:4/18/2015)... (PRWEB) April 18, 2015 Carinsurancequotesinfo.com has ... insurance can cover physical injuries caused by a ... excellent financial coverage for a vehicle. A policy can ... by an accident. Drivers should always carry appropriate coverage ... insurance policy can be bought with several important riders ...
(Date:4/18/2015)... 2015 Review of Ophthalmology magazine and ... for Success’ program for cataract surgeons attending the American ... Diego, where eye surgeon Jeffrey L. Martin, MD will ... Dr. Martin is the Managing Partner of North Shore ... Dr. Martin to lead this year’s discussion on the ...
Breaking Medicine News(10 mins):Health News:Preventing Cancer with Broccoli Sprout Extract 2Health News:Preventing Cancer with Broccoli Sprout Extract 3Health News:Lipitor Lawsuits Mount, as New Court Report Shows More Than 100 Filings Added to Federal Litigation Since March 2Health News:Lipitor Lawsuits Mount, as New Court Report Shows More Than 100 Filings Added to Federal Litigation Since March 3Health News:Lincoln, NE’s Bowling for Brains to benefit Renowned Brain Aneurysm Foundation 2Health News:Lincoln, NE’s Bowling for Brains to benefit Renowned Brain Aneurysm Foundation 3Health News:Auto Insurance Plans Can Cover Physical Injuries Caused By An Accident! 2Health News:Dr. Jeffrey Martin Invited to Share Latest Breakthroughs in Cataract Care During Roundtable Discussion at National 2015 ASCRS Meeting In San Diego 2
... Thursday asked the government, the railway ministry and the Indian ... petition accusing them of supplying unhygienic food to rail passengers.// ... Khetrapal issued notice to the respondents to file their replies ... entrusted with the task of supplying food to passengers on ...
... Society Wolfson Research Professor and inventor of DNA Fingerprinting ... which will be awarded to him later this year. ... Heineken Prize for Biochemistry and Biophysics 2006 by the ... of the discovery of the revolutionary technique. ...
... shake-up of the out of hours health care system in England ... ,The public accounts committee claimed that the new health ... met many key targets. ,In 2004 most GPs had ... which PCTs took over in 90% of cases. ,The ...
... launched by the Cancer Research UK, and its ... take up// drug candidates that pharmaceuticals companies have ... their preclinical studies. By this they plan to ... been shelved by pharmaceutical and biotechnology companies. ...
... and Aberdeen University in Scotland found that women with ... have twins// following in vitro fertilization. They found that ... multiple births after fertility treatment. ,However, the ... protects against birth defects such as spina bifida, does ...
... Embryology Authority show that recently there is a surge ... technology// (ART) in the UK. It is astonishing to ... 34. There is increase in women choosing to delay ... and scientists say that there are long-term risks associated ...
Cached Medicine News:Health News:Inventor of DNA fingerprinting Wins Accolades 2Health News:Cancer Research UK Offers New Hope To Cancer Patients 2Health News:High Levels Of Folic Acid May Increase The Chances Of Twins After IVF 2
(Date:4/17/2015)... Nonin Medical, a global leader in noninvasive medical monitoring, ... Steve Bucholz will retire May 1. Company founder ... Chief Executive Officer. In addition, Mr. Isaacson will continue ... transition to David Noel , Chief Financial Officer. ... to Nonin Medical,s growth," Mr. Isaacson said. "Under Steve,s ...
(Date:4/17/2015)... R.I , April 17, 2015 CVS ... a conference call on Friday, May 1, 2015, at ... its first quarter financial results. An audio ... through the Investor Relations portion of the CVS Health ... visit http://investors.cvshealth.com . This webcast will be archived ...
(Date:4/17/2015)... ASSESS shows   plasma circulating tumour DNA (ctDNA) ... tumour biopsy   IGNITE supports value of ... AstraZeneca today presented results from two key studies ... for epidermal growth factor receptor (EGFR) mutation status in newly ... clinical practice. [ 1 ] , ...
Breaking Medicine Technology:Nonin Medical's Philip Isaacson Expands CEO Role; President and COO Steve Bucholz to Retire May 1 2"Real World" Data Support Use of Blood Test for EGFR Mutation in Advanced NSCLC 2"Real World" Data Support Use of Blood Test for EGFR Mutation in Advanced NSCLC 3"Real World" Data Support Use of Blood Test for EGFR Mutation in Advanced NSCLC 4
... AUG. 2 Two major studies,published today in The ... pregnant women at risk for preterm delivery who can ... today. In one large multi-center trial led by ... whom had no prior history of preterm birth) who,received ...
... Population of Glioblastoma Patients Expected to Support ... Promising New Approach -, TUSTIN, Calif., Aug. 2 ... stage biopharmaceutical,company developing targeted monoclonal antibodies for the treatment ... the first,patient has been administered Cotara(R) in a new ...
Cached Medicine Technology:Progesterone Therapy and Preterm Birth: More Evidence Helps Identify Women Who Can Benefit 2Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India 2Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India 3Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India 4
... new Vivid i is ... to provide high-performance, full-featured imaging in a ... addresses one of the biggest ... complete, real-time diagnostic information. The new system ...
... CRP test is an immunochromatography based ... is designed for semi-quantitative determination of ... serum or whole blood specimens. The ... or whole blood can be detected ...
The Bio-Quant CK-MB test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of,CK-MB in human serum specimens as an aid in the diagnosis of myocar...
This advanced digital monitor detects the appearance of an irregular heartbeat during measurement and gives a warning signal with your reading. An irregular heartbeat may cause or indicate cardiovasc...
Medicine Products: