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:10/17/2014)... This news release is available in German . ... need millions of sperms every day in order to reproduce? ... questions are the topic of the latest issue of the ... 16th, 2014). The evolutionary biologist Steven Ramm from Bielefeld University ... nature, it is not unusual for a female to copulate ...
(Date:10/16/2014)... war on the human body. Battles are won, ... pancreatic cancer, this stalemate—known as tumor dormancy—can last ... a phenomena that is poorly understood. , ... of Salvatore Torquato, a Professor of Chemistry at ... tumor dormancy and the switch to a malignant ...
(Date:10/16/2014)... challenged conventional thinking on how the bowel lining develops ... how bowel cancer starts. , The researchers produced evidence ... the ,crypts, that are a feature of the bowel ... bowel cancer development, a controversial finding as scientists are ... 3D imaging technologies, Dr Chin Wee Tan and Professor ...
Breaking Biology News(10 mins):Sperm wars 2Modeling tumor dormancy 2Cryptic clues drive new theory of bowel cancer development 2
... - Animals that choose to eat in the presence of a ... go into a defensive mode and pay a physical penalty for ... crop pest hornworm caterpillar, a study shows. While other animals ... hornworm caterpillars slow or stop eating but actually keep up their ...
... to participate in ELIXIR ( www.elixir-europe.org ), a major ... in Europe. With one of Europe,s larger economies now ... is well placed to continue its excellent progress. ... infrastructure for managing biological data to support research and ...
... the IRCM, led by geneticist Dr. Jacques Drouin, recently ... inflammation. This important breakthrough will be published in tomorrow,s ... . IRCM scientists study glucocorticoids, a class ... reduce inflammation. They are used in medicine to treat ...
Cached Biology News:Caterpillar gets more from its food when predator is on the prowl 2Italy pledges to be part of ELIXIR research infrastructure 2Controlling inflammatory and immune responses 2
(Date:10/19/2014)... 19, 2014 The Asian Automatic patient ... with analysis and forecast of revenue. The Automatic patient ... around $463.9 million by 2018, at a developing CAGR ... the TOC of the Asian Automatic patient billing market, ... This also provides a glimpse of the segmentation of ...
(Date:10/19/2014)... According to market research report “Outdoor Wi-Fi ... gateways)]- Global Advancements, Forecasts and Analysis (2013 - ... market with analysis and forecasting of the global ... drivers and the restrains for this market with ... , Browse 65 market data tables and 69 ...
(Date:10/18/2014)... 2014 The Asia-Pacific hardware encryption display ... Asia-Pacific with analysis and forecast of revenue. This market ... to reach $51,362.6 million by 2018, at a CAGR ... the TOC of the Asia-Pacific hardware encryption market report, ... This also provides a glimpse of the segmentation of ...
(Date:10/18/2014)... October 18, 2014 The report ... Intelligence] - Text; Web; Speech; Machine; Video; Predictive ... Roadmap, Market Forecasts & Analysis (2013 - 2018) ... Market into various sub segments with an in-depth ... also identifies the factors driving this market, various ...
Breaking Biology Technology:The Asian Automatic patient billing market is estimated to grow to around $463.9 million by 2018 - New Report by MicroMarket Monitor 2The Asian Automatic patient billing market is estimated to grow to around $463.9 million by 2018 - New Report by MicroMarket Monitor 3Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 2Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 3Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 4The Asia-Pacific hardware encryption display market is expected to reach $51,362.6 million by 2018 - New Report by MicroMarket Monitor 2The Asia-Pacific hardware encryption display market is expected to reach $51,362.6 million by 2018 - New Report by MicroMarket Monitor 3Cloud Analytics Market (by Cloud Business Intelligence & Predictive Analytics) Expected to Cross $16.52 Billion by 2018 - New Report by MarketsandMarkets 2Cloud Analytics Market (by Cloud Business Intelligence & Predictive Analytics) Expected to Cross $16.52 Billion by 2018 - New Report by MarketsandMarkets 3Cloud Analytics Market (by Cloud Business Intelligence & Predictive Analytics) Expected to Cross $16.52 Billion by 2018 - New Report by MarketsandMarkets 4Cloud Analytics Market (by Cloud Business Intelligence & Predictive Analytics) Expected to Cross $16.52 Billion by 2018 - New Report by MarketsandMarkets 5
... , EXTON, Pa., July 15 ... and Cancer Innovations, Inc. (CII), a privately held biotechnology company ... they have entered into an evaluation and option agreement in ... , , The ...
... , , MADISON, Wis., ... (CDI) today announced that it has exclusively in-licensed a US-issued patent portfolio ... cells (cardiomyocytes) in drug testing. , , ... and Indiana University-Purdue University Indianapolis (IUPUI), covers ...
... , PRINCETON, N.J., July 15 ... license agreement with Merck KGaA, Darmstadt, Germany, providing the global ... platform for the research, development and commercialization of their antibody ... , "We are extremely pleased about ...
Cached Biology Technology:Morphotek(R), Inc. and Cancer Innovations, Inc. Announce Evaluation and Option Agreement for Therapeutic Monoclonal Antibodies 2Morphotek(R), Inc. and Cancer Innovations, Inc. Announce Evaluation and Option Agreement for Therapeutic Monoclonal Antibodies 3Cellular Dynamics International In-Licenses Key Patent Portfolio for Using Stem Cell-Derived Cells in Drug Testing 2Cellular Dynamics International In-Licenses Key Patent Portfolio for Using Stem Cell-Derived Cells in Drug Testing 3BioWa Announces License of POTELLIGENT(R) Technology to Merck KGaA 2
... monoclonal antibody reactive against the complex IV assembly ... in growing cultured cells. SURF1 is an important ... thought to participate in the folding of subunit ... Mutations of SURF1, particularly ones that result in ...
... (Thr183/Tyr185) Antibody Kit Kit Includes: ... #9251, 200 ul SAPK/JNK (56G8) Rabbit ... Cell Extracts, Catalog #9253, (4 Western ... #7074, 100 ul Anti-biotin IgG, HRP-linked ...
100 g monoclonal antibody which can immunocapture ~10 g of Complex IV from heart mitochondria. Also included are 2 mg of bovine heart mitochondria for control immunocapture....
Anti-gp120/160(SIV/mac239) Immunogen: gp120(SIV/mac239) protein (Genebank accession #M33262)...
Biology Products: