Navigation Links
AMP presents at FDA meeting on regulating diagnostics
Date:7/20/2010

College Park, MD (July 20, 2010): The Association for Molecular Pathology (AMP) participated in the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) public meeting on the oversight of laboratory developed tests (LDTs). Dr. Karen Mann, President of AMP, served on the second panel of the meeting titled, Clinical Laboratory Challenges. Additionally, Dr. Elaine Lyon, Chair of the AMP Professional Relations Committee, presented public comments. "AMP believes that LDTs are an essential and central component of medical practice," said Dr. Lyon, "Without LDTs, the practice of medicine that we know today would be severely reduced in scope."

LDTs continue to play essential and formative roles in delivery of preventative care, diagnosis, and disease management, and AMP believes that only high quality, clinically and analytically valid diagnostic tests should be performed in clinical laboratories. Also, all laboratories should meet CLIA standards, adhere to established guidelines, and seek appropriate certifications and accreditations.

AMP believes that a regulatory model should not interfere with the practice of medicine, and it is important to recognize the value of the current oversight system for enabling clinical laboratories to rapidly incorporate new findings into practice and to modify existing laboratory tests and their usage in accordance with advances in our understanding of clinical utility and disease pathogenesis. Dr. Lyon noted, "Nimble innovation in new test development is crucial to our ability to respond to emerging public health challenges, which was evident during the 2009 H1N1 influenza outbreak."

There is a lack of review of current and proposed oversight models. In its remarks, AMP encouraged the FDA to collect data and assess the effectiveness of existing oversight models prior to implementing new approaches, as it will be extremely important to demonstrate that any propo
'/>"/>

Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

Page: 1 2 3

Related biology news :

1. AAPS presents therapeutic protein drug interactions workshop
2. ASNTR meeting presents Sanberg Awards to Prof. Lin & Prof. Dunnett
3. Latino Theater Company Presents Dementia Starting April 29
4. Hormone sensitivity of breast stem cells presents drug target
5. NYU School of Medicine presents biomedical researchers Dart/NYU Biotechnology Achievement Awards
6. P&G Beauty & Grooming presents advancements in skin care at AAD Annual Meeting
7. Autism Speaks presents the top ten autism research findings of 2009
8. New edition of popular lab manual presents latest techniques for probing cellular dynamics
9. DoseCue(TM) Presents Positive Study Results at BioTech 2009
10. Nucleix Presents DNA Authentication Technology at 20th International Symposium on Human Identification
11. InVitria Presents Zap-CHO Performance Results at PEACe Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/6/2015)... SAN JOSE, Calif. , Aug. 6, 2015 ... the leading developer of human interface solutions, today ... and TouchPad technologies on Windows 10. Microsoft leveraged ... fundamental to the operating system. ... and drivers are fully certified with Microsoft,s Precision ...
(Date:8/4/2015)... ) today reported financial and operating results for the second quarter ... quarter contract revenue of $ 85.2 million, a ... of 26 % , Second quarter adjusted ... royalties in the current quarter , Operating cash ... to present another strong financial quarter, with all our divisions achieving ...
(Date:7/31/2015)... 2015 La 10e Conférence internationale sur ... par le BGI du 22 au 25 octobre ... Chine. La conférence célèbre son 10e ... l,ICG est devenue l,une des réunions annuelles mondiales ... et c,est aussi la plus dynamique, la plus ...
Breaking Biology News(10 mins):Synaptics Chosen for Human Interface Co-Development on Windows 10 2AMRI Announces Second Quarter 2015 Results 2AMRI Announces Second Quarter 2015 Results 3AMRI Announces Second Quarter 2015 Results 4AMRI Announces Second Quarter 2015 Results 5AMRI Announces Second Quarter 2015 Results 6AMRI Announces Second Quarter 2015 Results 7AMRI Announces Second Quarter 2015 Results 8AMRI Announces Second Quarter 2015 Results 9AMRI Announces Second Quarter 2015 Results 10AMRI Announces Second Quarter 2015 Results 11AMRI Announces Second Quarter 2015 Results 12AMRI Announces Second Quarter 2015 Results 13AMRI Announces Second Quarter 2015 Results 14AMRI Announces Second Quarter 2015 Results 15AMRI Announces Second Quarter 2015 Results 16AMRI Announces Second Quarter 2015 Results 17AMRI Announces Second Quarter 2015 Results 18AMRI Announces Second Quarter 2015 Results 19AMRI Announces Second Quarter 2015 Results 20AMRI Announces Second Quarter 2015 Results 21AMRI Announces Second Quarter 2015 Results 22AMRI Announces Second Quarter 2015 Results 23AMRI Announces Second Quarter 2015 Results 24La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 2La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 3
... Voter Rolls and ... National ID Cards, ... Bulletin Board: BKYI), a leader in,finger-based biometric identification and wireless public ... prepackaged and customized software,solutions, today announced that they have been awarded ...
... the topping-out ceremony for the experimental hall of PETRA III ... Hamburg. On occasion of the structural completion of the building, ... Ole von Beust visited the Helmholtz research centre DESY. Its ... in 2009. PETRA III is a milestone on the ...
... A pasture improvement research program by Dr. Dariusz Malinowski ... an alternative to winter wheat pastures. But these ... parts of the nation, said Malinowski, a Texas Agricultural ... the Mediterranean Basin of southern Europe and northern Africa. ...
Cached Biology News:BIO-key(R) and Tiger IT Awarded a Follow-on Contract for Nationwide Voter / Citizen Registration in Bangladesh 2BIO-key(R) and Tiger IT Awarded a Follow-on Contract for Nationwide Voter / Citizen Registration in Bangladesh 3BIO-key(R) and Tiger IT Awarded a Follow-on Contract for Nationwide Voter / Citizen Registration in Bangladesh 4Brilliant perspectives 2Brilliant perspectives 3Summer-dormant tall fescue grass shows promise for pasture improvements 2Summer-dormant tall fescue grass shows promise for pasture improvements 3
(Date:8/31/2015)... , Aug. 31, 2015 LabStyle ... Diabetes Management Solution, today announced it recently closed ... Funds will be used to support the global ... Dario, a mobile, cloud-based, diabetes management solution that ... ,all-in-one, pocket-sized, blood glucose monitoring device, and for ...
(Date:8/31/2015)... ... August 31, 2015 , ... ... most successful food and beverage processors, equipment manufacturers and leaders in the field ... and industrial weighing and formulation for manufacturers of bakery and snacks; beverages; dairy; ...
(Date:8/30/2015)... , England , August 31, ... beendet die 51-jährige Wartezeit   einer Frau   für ... Frauen im Alter von 7-90   werden ... Programm soll 1200 Frauen behandeln und die ... , Astellas gab heute bekannt, ...
(Date:8/28/2015)... ... August 28, 2015 , ... ... two studies at the International Spine Intervention Society’ s 23rd Annual ... to August 1st, 2015. With a focus on evidence-based research and clinical application, ...
Breaking Biology Technology:LabStyle Innovations Closes $2.5 Million Funding to Support Global Rollout of Dario Diabetes Management Solution 2LabStyle Innovations Closes $2.5 Million Funding to Support Global Rollout of Dario Diabetes Management Solution 3LabStyle Innovations Closes $2.5 Million Funding to Support Global Rollout of Dario Diabetes Management Solution 4METTLER TOLEDO Hosts Food Safety Educational Center at 2015 PROCESS EXPO 2Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 2Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 3Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 4Über 550 Frauen, deren Leben durch "Action on Fistula" transformiert wurde 5Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 2Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 3Proove Biosciences Presents New Research Study at the International Spine Intervention Society’s Annual Scientific Meeting 4
... PITTSBURGH, Feb. 2, 2011 Forensic DNA profiling has ... people in the aftermath of mass violence and disaster, ... to identify and analyze the major ethical and policy ... (Logo: http://photos.prnewswire.com/prnh/20020422/CMULOGO) The National ...
... 2, 2011 New England Biolabs has expanded its ... generation sequencing to include NEBNext® Small RNA Sample Prep ... NEBNext Small RNA Sample Prep Set 3 for sequencing ... new and unique protocol, which results in higher yields ...
... N.M., Feb. 2, 2011 Elixir Bio-Tech Inc. (EBT), ... one of the top fifty winners of the FundingPost,s ... EBT is launching its Algae Biomass Feedstock project in ... multi-purpose feedstock with ground-breaking Proprietary and Patent Pending Technology ...
Cached Biology Technology:CMU Receives $1.2 Million NIH Grant To Develop Ethics, Policy Recommendations for Post-Conflict, Post-Disaster DNA ID Practices 2CMU Receives $1.2 Million NIH Grant To Develop Ethics, Policy Recommendations for Post-Conflict, Post-Disaster DNA ID Practices 3CMU Receives $1.2 Million NIH Grant To Develop Ethics, Policy Recommendations for Post-Conflict, Post-Disaster DNA ID Practices 4New England Biolabs Develops Novel Small RNA NGS Protocol: Reagents Improve Yield and Decrease Adaptor-Dimer Formation 2Elixir Bio-Tech Inc. Elected One of Top 50 Emerging Companies by 100 Venture Capital Funds & Angel Investors 2
EDTA, tetrasodium salt, 1 kg. Ethylene diaminetetraacetic acid.Dihydrate. Assay: 99-101% (as is).Risks: 36, 37, 38 ; Safety Precautions: 22, 36, 37. Category: Nucleotides & Enzymes & Biochemicals, Ul...
EDG-1 Western blot control Source: Cell Lysate Application: Western Blotting Control...
...
Kit containing positive control DNA all parts of the HIV-1 genome, HIV-1 negative control DNA, Primers SK38, SK39, SK19...
Biology Products: