Navigation Links
CAP Proposes Improved Oversight of Lab-Developed Tests
Date:9/24/2009

Three-tiered approach would categorize new LDTs by potential risk

WASHINGTON, Sept. 24 /PRNewswire-USNewswire/ -- The College of American Pathologists today announced new recommendations for strengthening oversight of laboratory-developed tests (LDTs), proposing a three-tier 'risk-based' system that would protect patients by ensuring every laboratory developed test is reported to an oversight body, and instituting a graduated system of review based on a test's potential risk to patients.

(Logo: http://www.newscom.com/cgi-bin/prnh/20081119/CAPLOGO)

"While the preponderance of laboratory developed tests present relatively low risk to patients, the increasing use and complexity of some LDTs underscores the need for increased oversight," said Jared N Schwartz, MD, Ph.D., FCAP, president of the College of American Pathologists. "CAP's risk-based model employs a public private partnership to address oversight of these tests in an inclusive, systematic way."

CAP's proposed changes would incorporate oversight of claims of clinical validity, and would specify scientific and regulatory standards to be applied to all LDTs. Risk would be determined based on claims made, potential risk to patients, and the extent to which its results could be used in the determination of diagnosis or treatment.

The College believes optimum oversight would be achieved by applying a risk-based classification (low-, moderate-, or high-) to every LDT; strengthening CLIA accreditation standards on labs using low- and moderate-risk LDTs, and requiring FDA review of all high-risk LDTs.

"Laboratory-developed tests (LDTs) represent some of the most innovative clinical testing being offered to patients today, and have
'/>"/>

SOURCE College of American Pathologists
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. FDA Proposes New Rules for Sunscreens
2. Carnegie Mellon neuroscientist proposes new theory of brain flexibility
3. Lake Forest Hospital Proposes a New Health Care System in Lake County
4. California Stem Cell Agency Proposes Unjustified Increase in Top Salary Ranges
5. HRSA Proposes Rule to Revise, Combine HPSAs, MUPs
6. National Patient Safety Foundation Proposes Universal Patient Compact
7. CardioDynamics Board of Directors Proposes Reverse Split 1:7 of Companys Shares
8. Governor Rendell Proposes County Grants to Combat West Nile Virus, Protect Public Health
9. Navigenics Proposes Standards for Personal Genomics Services, Coupled With Prospective Outcomes Studies, to Safeguard Consumers
10. Brandes Proposes 130 yen per Share Dividend and 10 Million Share Buyback Program for Ono Pharmaceutical Annual Meeting
11. FDA Proposes New Drug Labels for Pregnant Women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... UWDress.com, a leading online supplier of wedding dresses and women’s ... empire bridesmaid dresses to its product line. In addition ... these high quality items. All of them are now available ... , The company’s new items can definitely add beauty ... website. It is true that all its products are more ...
(Date:8/22/2014)... CA (PRWEB) August 22, 2014 Japantown ... offering a new teeth whitening technique. Air polishing is ... cleaning appointments. , Dark teeth can be caused by ... categories: external stains and internal stains. External stains include ... can be caused by certain medications, such as tetracycline, ...
(Date:8/22/2014)... Amy Norton HealthDay Reporter ... growing number of Americans on work disability chronically use ... Researchers found that between 2007 and 2011, about 44 ... were prescribed narcotic painkillers each year. And the percentage ... 2007 to 23 percent in 2011. Experts ...
(Date:8/22/2014)... 2014 As the controversy surrounding ... in uterine surgeries continues to grow, Bernstein Liebhard ... decided to limit coverage of uterine morcellation. According ... Cross-Blue Shield of Massachusetts will no longer cover ... as of September 1, 2014. Other insurers in ...
(Date:8/22/2014)... Vegas, NV (PRWEB) August 22, 2014 ... that uses university-proven research to show people how they can ... lean muscle in only a matter of weeks has caught ... , “Ben Pakulski is one of the most well-known bodybuilders ... get the body he has today, that in itself is ...
Breaking Medicine News(10 mins):Health News:Discounted Empire Bridesmaid Dresses Online At UWDress.com 2Health News:Japantown Dental Introduces Air Polishing 2Health News:Many U.S. Workers on Disability Use Narcotic Painkillers, Study Finds 2Health News:Many U.S. Workers on Disability Use Narcotic Painkillers, Study Finds 3Health News:Many U.S. Workers on Disability Use Narcotic Painkillers, Study Finds 4Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 2Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 3Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 4Health News:Mi40x: Review Exposes Ben Pakulski’s Guide to Packing on Lean Muscle Fast 2
... to bring an end to the double–penalty system for health trusts ... a health trust falls into deficit, not only is it penalized ... money is cut off from its allocated funds from the ensuing ... health trusts find it virtually impossible to balance accounts and have ...
... Millions of Americans whose vision is slowly ebbing due to ... the lowly neural progenitor cell may be useful for restoring ... rats, neural progenitor cells derived from human fetal stem cells ... degenerative eye disease similar to the kinds of diseases that ...
... control high blood pressure and new drugs that target ... have designed two promising new cardiovascular treatment approaches, a ... to lower high blood pressure and a therapeutic hybrid ... ,In the process, they have overcome ...
... new study finds the popular anti-clotting drug clopidogrel (Plavix) when ... safe without any adverse bleeding event.// ,The ... 56th Annual Scientific Session on March 27 at 9 am ... aspirin, will not worsen bleeding after off-pump heart bypass surgery. ...
... multi-center study concludes that women with a recent diagnosis of ... opposite breast.// ,This study was conducted by ... ,The international research team found that MRI, or ... 30 of 969 women (3.1 percent) who had recently been ...
... considering vaccinating young girls against a virus that causes cervical ... Robert Koch-Institute in Germany has recommended the universal vaccination of ... ,The Italian Ministry of Health has announced that vaccination of ... as regional vaccination centers are prepared. ,Government ...
Cached Medicine News:Health News:Double-penalty System for Bankrupt Health Trusts Lifted 2Health News:Stem Cell Therapy Shows Promise for Rescuing Deteriorating Vision 2Health News:Stem Cell Therapy Shows Promise for Rescuing Deteriorating Vision 3Health News:Hormone-based Heart Pill to Control High Blood Pressure 2Health News:Hormone-based Heart Pill to Control High Blood Pressure 3Health News:Plavix Safe During and After Heart Bypass 2Health News:MRI Screening of Other Breast Crucial for Patients Diagnosed With Cancer in One Breast 2
(Date:8/22/2014)... Research and Markets has announced the addition ... Report 2014" report to their offering. ... 2014 is a professional and in-depth study on the ... a focus on the Chinese situation. The report ... classifications, applications and industry chain structure. The particulate respirators ...
(Date:8/22/2014)... , August 22, 2014 ... TVs Today Lincor announced general availability of ... solution that delivers a range of education, entertainment and ...      (Logo: http://photos.prnewswire.com/prnh/20140822/702945) , " ... point of care patient engagement to bedside smart devices, ...
(Date:8/22/2014)... , Aug. 22, 2014 /PRNewswire/ - SQI Diagnostics ... develops and commercializes proprietary technologies and products for ... entered into a Master Service Agreement to contract ... pathogen detection assays. During the initial phase of ... an automated working prototype of one of the ...
Breaking Medicine Technology:Global and Chinese Particulate Respirators Industry Report 2014 2Lincor Unveils Next Generation TV-based Patient Engagement Solution 2SQI Diagnostics Contracted to Automate Pathogen Detection Assays 2SQI Diagnostics Contracted to Automate Pathogen Detection Assays 3
... Md., Feb. 10, 2011 Neuralstem, Inc. (NYSE Amex: ... I human clinical trial of the company,s spinal cord stem ... Lou Gehrig,s disease) at Emory University in Atlanta, Georgia. The company ... nine patients, the trial,s Safety Monitoring Board has unanimously approved ...
... On January 26, 2011, it was reported that ... severely by rhabdomyolysis that they were hospitalized.  Occurrences of ... causal factor, such as a drug. Drugs ... known in rare cases to cause rhabdomyolysis.  It seems ...
Cached Medicine Technology:Neuralstem Updates ALS Clinical Trial Progress 2Neuralstem Updates ALS Clinical Trial Progress 3Neuralstem Updates ALS Clinical Trial Progress 4Did ADHD Drugs Cause Muscle Damage in Iowa Football Players? 2
... Thermo Scientific Finnpipette Dispenser cover all volumes ... very high consistency, precision and reproducibility, due ... The Finnpipette Dispenser range is the latest ... manual liquid handling products, offering users reliability ...
... compact, mobile femtosecond surgical laser, has been ... for a wide spectrum of applications in ... demand of refractive surgeons for an "all-Laser ... efficient LASIK work-flow. The solution by Ziemer ...
... EHEC is the first one-step 20 minutes rapid ... and 2 produced by Enterohemorrhagic Escherichia coli in ... overnight enrichment of fecal specimens and detects all ... The separate result for Toxin 1 and 2 ...
Inquire...
Medicine Products: