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

sed oversight system would lead to improved health outcomes.

AMP believes that LDTs in all disciplines of laboratory medicine should be subject to the same oversight mechanisms, and that molecular or genetic tests should not singled out for heightened scrutiny simply due to the heritable nature of nucleic acids. AMP does agree that some tests may require greater scrutiny and may warrant additional regulatory review. An LDT that may require further regulation is one that:

  • Uses a non-transparent algorithm with multiple markers that cannot be elucidated by other test developers, or
  • Relies on technology that is not easily replicated by multiple laboratories, and for which
    • a false result would cause significant morbidity or mortality, or
    • a false result could have a widespread adverse effect for public health

However, Dr. Lyon expressed concern about the impact on low volume tests, "We feel it's important to recognize the potential impact of increased oversight on infrequent or low volume tests. Overzealous regulation of such tests could prove to be overly burdensome and cost prohibitive for laboratories developing and offering important but infrequently utilized tests."

To advance the field of molecular pathology, any new oversight policy should also work to address the barriers to test development. Specifically, AMP believes the recognition and implementation of advances in medical research may be hindered by a lack of certified reference materials and encourages the government to support the development of these materials at the National Institute of Standards and Technology. Dr. Lyon explained, "Molecular assays provide the cutting edge for many individualized therapies in oncology, transplantation, infectious disease and genetics, but the production of certified reference materials has fallen far behind the technical capabilities of these assays which are needed to ensure sensitivity,
'/>"/>

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:9/15/2014)... of wild, domesticated, and domesticated-wild hybridized populations ... found that within 5 to 11 generations, ... wild populations that hybridized with domesticated populations. ... provides evidence that natural selection, over time, ... experience as a result of increased genetic ...
(Date:9/15/2014)... unprecedented evolution experiment scientists from GEOMAR Helmholtz Centre ... of Sea Fisheries have demonstrated for the first ... of the world,s oceans, Emiliania huxleyi , ... water temperatures. In their study, the researchers found ... adaptations to these two aspects of climate change ...
(Date:9/15/2014)... subsequent rapid decrease in the water level of Lake ... kilometres of new, fertile land in eastern Finland. A ... has studied the role that the decrease in water ... humans. After dramatic shifts in the waterways, human life ... to a new, innovative culture. This stemmed from an ...
Breaking Biology News(10 mins):Small algae with great potential 2Small algae with great potential 3The creation of the Vuoksi River preceded a significant cultural shift 2
... Fla. --- The BP Deepwater Horizon oil spill temporarily worsened ... but there may be cause for optimism, according to a ... Proceedings of the National Academy of Sciences found ... 30 feet from the shoreline and this plant die off ...
... 12th International Coral Reef Symposium (ICRS 2012), the world,s ... years, will begin Monday, July 9, in Cairns, Queensland, ... who are in attendance, and accessibility to this information ... online media portal to journalists worldwide. In addition to ...
... manage to react to their environment is not yet ... El-Mashtoly from the RUB Department of Biophysics, led by ... the molecular interactions during aerotaxis of Bacillus subtilis ... the oxygen concentration in the environment. The research team ...
Cached Biology News:BP Deepwater Horizon oil spill exacerbated existing environmental problems in Louisiana marshes 2BP Deepwater Horizon oil spill exacerbated existing environmental problems in Louisiana marshes 3Topics to be discussed during July International Coral Reef Symposium 2Topics to be discussed during July International Coral Reef Symposium 3Topics to be discussed during July International Coral Reef Symposium 4Topics to be discussed during July International Coral Reef Symposium 5How bacteria change movement direction in response to oxygen: Molecular interactions unravelled 2
(Date:9/15/2014)... , Sept. 15, 2014 Zymo Research ... transport solution for safe ambient temperature storage and ... testing. Importantly, the infectivity of agents in such samples ... the integrity of the viral nucleic acids for ... recent Ebola epidemic in West Africa ...
(Date:9/15/2014)... (PRWEB) September 15, 2014 Applied ... implantable silicones for the medical device and critical ... gel for the implantable medical device market. ... crosslink technology delivering a silicone gel with improved ... Dual Matrix technology consists of two crosslinked networks ...
(Date:9/15/2014)... , Sept. 15, 2014  The second annual ... celebrated October 12-18. A joint initiative of the ... member companies , IPAW is designed to: ... , Recognize the contributions of plasma donors in saving ... plasma protein therapies and rare diseases ...
(Date:9/14/2014)... when it comes to survival strategies. They often create ... for example during treatment with antibiotics. A biofilm is ... slime capsule consisting of sugar chains and "curli". ... the first time created a detailed three-dimensional image of ... the bacterial cell wall, a crucial step in the ...
Breaking Biology Technology:Safe storage and transport of Ebola, Mers-CoV, and other viruses: Groundbreaking viral inactivation solution capable of preserving nucleic acids 2Safe storage and transport of Ebola, Mers-CoV, and other viruses: Groundbreaking viral inactivation solution capable of preserving nucleic acids 3Applied Silicone Launches Silicone Gel System with Dual Matrix Technology 2International Plasma Awareness Week To Celebrate Donors And Spotlight Rare Diseases 2International Plasma Awareness Week To Celebrate Donors And Spotlight Rare Diseases 3New insights in survival strategies of bacteria 2
... 7 LifeCell Corporation,(Nasdaq: LIFC ), today announced ... to the final settlement of a claim that arose ... expected to reduce,diluted net income per share by approximately ... 2008, since the Company,s 2007,financial statements were not yet ...
... Calif., Feb. 7 Avicena Group, Inc.,(OTC Bulletin ... nervous system therapeutics for neurodegenerative,disorders, announced today that ... will present an overview of the company,s,ongoing clinical ... & Investor,Conference to be held February 11-13, 2008 ...
... Inc., a,biotechnology company focused on the development of ... announced today,that its co-founder and CEO Mitchell P. ... from the American College of Critical Care,Medicine during ... of Critical,Care Medicine held February 2-6 in Honolulu, ...
Cached Biology Technology:LifeCell Corporation Revises Full Year 2007 Preliminary Results and Schedules Fourth Quarter 2007 Financial Results Conference Call; February 27, 2008 at 10:00 a.m. Eastern 2Avicena Group to Present at 10th Annual BIO CEO & Investor Conference 2Avicena Group to Present at 10th Annual BIO CEO & Investor Conference 3Logical Therapeutics Co-Founder and CEO Honored with a Distinguished Investigator Award from the American College of Critical Care Medicine 2
High-throughput DNA preparation and end sequencing of BAC libraries. 3730xl DNA sequencers. LIMS tracking utilizing Geospiza's Finch system. Full-length BAC sequencing also available. Our expertise h...
...
Methylation analysis of gene promoters using bilsulfite treatment of DNA and comparative DNA sequence analysis. Probe design and PCR included....
... offers quick turnaround sequencing of individual research ... high copy plasmids. Agencourt's world-class, high performance ... bases per day. The key benefits ... are 24 48 hour sample turnaround, ...
Biology Products: