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:1/22/2015)... 2015  Today, FreeWavz ( www.FreeWavz.com ), the developer ... on Fundable, https://www.fundable.com/freewavz . FreeWavz will be ... to meet customer demand. Logo - ... Invented by Dr. ...
(Date:1/22/2015)... N.C. , Jan. 16, 2015  A man-made form ... memory and other mental capabilities in adults with mild ... pilot study led by researchers at Wake Forest Baptist ... adults diagnosed with amnesic mild cognitive impairment (MCI) or ...
(Date:1/22/2015)... Report Issued by Small Cap IR. In 2011, Nilson Report,s ... at merchants on the leading payment cards rose to $135.3 ... and prepaid cards reached 6.54 billion.  Eight million credit card ... in 2012, and credit and debit card fraud resulted in ...
Breaking Biology News(10 mins):FreeWavz Launches on Fundable to Drive Speed-to-Market in 2015 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 3$4.80 Near Term Price Target with "Buy" given by CapRock Research for NXT-ID, Inc. (NASDAQ: NXTD) issued by Small Cap IR 2
... John Smol of Queen,s University in Kingston, Ontario, Canada, ... one of the five prestigious Premier,s Discovery Awards for 2009. ... of the Environmental Scientists of the Year by The Royal ... is series editor of the Springer book series Developments in ...
... Mass., June 2, 2009 -- New research shows some bees ... hind legs while flying. But this approach comes at a ... flight by roughly 30 percent, and cutting into the bees, ... Proceedings of the National Academy of Sciences . ...
... Ocean acidification, a direct result of increased CO2 emission, ... and may have a direct impact on our economy, ... Intensive fossil-fuel burning and deforestation over the last ... 40%, which has in turn fundamentally altered ocean chemistry ...
Cached Biology News:Springer Series editor John Smol receives two prestigious biology awards 2Trading energy for safety, bees extend legs to stay stable in wind 2Who will pick up the bill? 2
(Date:1/22/2015)... Dr. Greg Leyer of UAS Labs recently was ... Pre-Conference seminar on probiotics in San Diego, CA. , ... conference for health care professionals. This year’s pre-conference seminar was ... in health. Dr. Leyer spoke about the emerging topics and ...
(Date:1/22/2015)... Geneva, Switzerland (PRWEB) January 22, 2015 ... for characterized mammalian Research Cell Banks (RCBs) used for ... generated Research Cell Banks will include Next-Generation Sequencing ... cell’s genetic architecture de-risks biologic manufacturing by ensuring the ...
(Date:1/22/2015)... NEW BRUNSWICK , Nueva Jersey , 22 ... Award for Biomedical Research abre hoy su llamada ... las personas cuya investigación científica ha hecho, o tiene ... de la salud humana. Las nominaciones se aceptarán hasta ...
(Date:1/22/2015)... , Jan. 22. 2015  Varian Medical Systems (NYSE: ... has been honored for its commitment to sustainability with inclusion ... Varian is the highest ranked healthcare equipment company among the ... during the World Economic Forum at Davos, Switzerland ...
Breaking Biology Technology:Selexis Generated Research Cell Banks Now Fully Sequenced Using Next-Generation Sequencing 2El Dr. Paul Janssen Award for Biomedical Research emite su llamada a los nominados para 2015 2El Dr. Paul Janssen Award for Biomedical Research emite su llamada a los nominados para 2015 3El Dr. Paul Janssen Award for Biomedical Research emite su llamada a los nominados para 2015 4Varian Honored Among World's 100 Most Sustainable Corporations 2
... 7, 2011 Reportlinker.com announces that ... available in its catalogue: ... Base, Applications, Purchase Plans and The ... http://www.reportlinker.com/p0681348/DNA-Microarray-Market-Trends-Installed-Base-Applications-Purchase-Plans-and-The-Impact-of-Next-Gen-Sequencing.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic ...
... Single vaccination effective against all influenza strains ... SEEK, a leading UK privately-owned drug-discovery group, today announced ... Vaccine Phase II challenge study. The full data will be ... USA. FLU-v is the first of a new ...
... 6, 2011 The shortlist of contenders for ... school students narrowed tonight as the winners of ... Region One Finals were announced.  Cancer stem cell ... scholarship for Angela Zhang of Cupertino, California.  Research ...
Cached Biology Technology:DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 2DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 3DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 4DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 5DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 6DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 7DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 8DNA Microarray Market Trends (Installed Base, Applications, Purchase Plans and the Impact of Next-Gen Sequencing) 9SEEK Announces Successful Phase II Challenge Study of its Universal Influenza Vaccine, FLU-v 2SEEK Announces Successful Phase II Challenge Study of its Universal Influenza Vaccine, FLU-v 3SEEK Announces Successful Phase II Challenge Study of its Universal Influenza Vaccine, FLU-v 4Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 2Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 3Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 4Biochemistry and Bioengineering Research Brings California Students Closer to Nation's Highest Science Honor for High School Students 5
... Fujifilm Life Science FLA-8000 Fluorescent Image Analyzer ... a single laser imaging system. This powerful ... labeled with fluorescent dyes or radioisotopes at ... demanding laboratories. Speed, image quality and flexibility ...
... cover slips for in situ hybridization,in ... on glass slides., Constant probe ... not adsorb probes. , Ready-to-use-Hybri-slips do ... , Avoid RNA degradation-Hybri-slips are supplied ...
...
...
Biology Products: