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:3/4/2015)... 04, 2015 Research and Markets ... the "Global Biometrics Market Forecast and Opportunities, ... The market for biometric authentication systems is projected ... till 2020 The driving forces for ... needs, government projects and constant development in technology. ...
(Date:3/2/2015)... , March 2, 2015   Neurotechnology , a ... introduced the SentiGaze Software Development Kit (SDK). ... applications that use off-the-shelf webcams to track eye movements ... at a monitor. Heatmaps can be used for applications ... of online advertising. The SDK can also be used ...
(Date:2/24/2015)... 2015 Research and Markets ( ... "Global 2D Gesture Recognition Market 2015-2019" ... analysts forecast the Global 2D Gesture Recognition market ... the period 2014-2019 The increased demand ... one of the major trends in the market. ...
Breaking Biology News(10 mins):Global Biometrics Market Forecast and Opportunities, 2020 2Global Biometrics Market Forecast and Opportunities, 2020 3Neurotechnology Releases SentiGaze SDK for Eye Movement Tracking Using Ordinary Webcams 2Neurotechnology Releases SentiGaze SDK for Eye Movement Tracking Using Ordinary Webcams 3Global 2D Gesture Recognition Market 2015-2019 with Cognitec Systems, CogniVue, eyeSight Mobile Technologies & PointGrab Dominating 2
... 2012 - The 2010 blowout of the Macondo well in ... region,s largest oil spill in U.S. history. As the Deepwater ... oil from coming to the surface and reaching coastal and ... powerful dispersants, typically used to break up oil slicks at ...
... Saito, a biogeochemist at Woods Hole Oceanographic Institution, has been ... the Gordon and Betty Moore Foundation. Saito is one of ... from a total of up to $35 million over five ... microbial ecology. "We are grateful to the Moore Foundation ...
... French . Thanks to the support of ... work together over a five-year period to translate the results ... the way for personalised medicine in CMDs. Researchers and clinicians ... be involved in the METACARDIS project. The aim of ...
Cached Biology News:Numerical study suggests subsea injection of chemicals didn't prevent oil from rising to sea surface 2Numerical study suggests subsea injection of chemicals didn't prevent oil from rising to sea surface 3WHOI scientist receives marine microbiology initiative investigator award from Moore Foundation 2METACARDIS: a European project that deciphers the genes of the gut microbiota 2METACARDIS: a European project that deciphers the genes of the gut microbiota 3
(Date:3/5/2015)... 2015 e2b teknologies , a ... in Northeast Ohio, today announced a leading independent multi-specialty ... its upgrade to the latest version of Sage ... practice of its kind in the region, the organization ... transactions, so efficiency and data accessibility are paramount to ...
(Date:3/4/2015)... Nev. , March 4, 2015 PDL BioPharma, Inc. ... adjusted conversion rate for the: , 3.75% Convertible ... 174.8506 shares of common stock per $1,000 principal amount or ... The conversion rate for the note is adjusted in connection ... on March 12, 2015, to all stockholders who own shares of ...
(Date:3/4/2015)... March 4, 2015  Brooklyn residents now have a ... chronic pain and injuries. Nunzio Saulle , M.D., ... opening of his NJS Physical Medicine and Rehabilitation (PM&R) ... Thursday, March 5, 2015. Health Plus Management, LLC is ... located at 1178 Flatbush Avenue. This new PM&R practice ...
(Date:3/4/2015)... , Mar. 04, 2015 Research and Markets ... addition of the "Global Biologics and Biosimilars ... , The Global Biologics and ... in-depth study on the current state of the ... provides a basic overview of the industry including ...
Breaking Biology Technology:Physician Group Practice Chooses e2b teknologies to Support Its Upgrade to Sage 100 ERP 2014 2PDL BioPharma Announces Conversion Rate Adjustment for Convertible Note 2NJS Physical Medicine & Rehabilitation Opening on Flatbush Avenue, Brooklyn, NY 2Global Biologics and Biosimilars Industry Report 2015-2020 2
... and managing to duck the hype of peer-to-peer networking, ... platform based on a "grid network" to accelerate the delivery ... a clever product director, Homer has guided Kontiki around the ... to build a platform and company that serves content providers ...
... Merge eFilm , the Milwaukee-based medical imaging technology company ... momentum leading into its proposed merger with Toronto-based Cedara ... more than $10.5 million in first-quarter 2005. , ,That's ... a 19 percent year-over-year jump in net sales in ...
... team of engineers and biologists has come up with a ... very small crystals and measuring their changing response to electricity. ... on the order of a handful of molecules. , ... and Robert Blick, found they could open new electrical channels ...
Cached Biology Technology:Creating a public service for multimedia content 2Creating a public service for multimedia content 3Creating a public service for multimedia content 4Merge eFilm earnings jump precedes planned merger 2Merge eFilm earnings jump precedes planned merger 3
Denhardt's Solution is a mixture of blocking agents used in membrane-based hybridization protocols. The solution contains 1% Ficoll (type 400) 1% polyvinylpyrrolidone and 1% bovine serum albumin. Ste...
... CHEMICONs ELF 97 Cytological Labeling Kit ... facilitate the detection of cellular targets, including ... 97 Cytological Labeling Kit contains the patented ... brightly fluorescent yellow-green precipitate at the site ...
... H 10 O 2 S 2 ... Form: White crystalline powder Assay: greater ... By IR Melting Point: greater than ... less than or equal to 1% ...
... Fluorescence Test Plate consists of an anodized ... Inert Organic Fluorescent Compounds embedded in polymerized ... on BioTeks FLx800 and Synergy Multi-Detection Readers. ... GLP compliance while reducing the need for ...
Biology Products: