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:12/10/2014)... DIEGO , Dec. 9, 2014 CIE ... collaboration catalyst that provides the connective tissue that enhances ... enabling them to easily share client-level information; earned a ... to expand to organizations serving seniors aging in community ... Diego" partner on December 11 th 4-6p. ...
(Date:12/5/2014)... Dec. 4, 2014 Increased emphasis on ... in new testing and inspection technologies. The convergence ... to a range of innovative test solutions. This ... Generation Y, which is generally more inclined towards ... product development strategies of test equipment vendors will ...
(Date:12/3/2014)... IRVINE, Calif. , Dec. 2, 2014 /PRNewswire/ ... of globally deployed, innovative test solutions for military, ... the newest version of its successful TS-900 ... the performance and features of high-end systems to ... with outstanding value compared to traditional ATE. ...
Breaking Biology News(10 mins):Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 2Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 3Community Information Exchange San Diego Launches Pilot, Secures $1 Million Expansion Grant, and Becomes a "Live Well San Diego" Partner 4Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 3Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 4Marvin Test Solutions Brings New Capabilities to PXI-Based Semiconductor Test with TS-960 2Marvin Test Solutions Brings New Capabilities to PXI-Based Semiconductor Test with TS-960 3
... has pieced together how the hominid Australopithecus sediba ... million years ago. Their research, which appears in six papers ... also shows that Au. sediba had a notable ... and more flexible lower back. Together, the studies offer ...
... purposely set to burn crop residues and get the ... evidenced in this image from the MODIS instrument on ... these types of fires can be found at this ... was collected by the Moderate Resolution Imaging Spectroradiometer (MODIS) ...
... new treatment for alcoholism called nalmefene is effective and ... says a new study published this week in ... as the primary treatment goal for alcohol dependence, and ... relapse prevention. However, relapse rates remain high and a ...
Cached Biology News:New research reveals how human ancestor walked, chewed, and moved 2New research reveals how human ancestor walked, chewed, and moved 3A new treatment option for alcohol dependence: Reduced consumption rather than abstinence 2
(Date:12/17/2014)... 17, 2014 Once more, EMAAR ... larger packaged waste water treatment plant to phase one ... City (KAEC). Two years ago Bioshaft successfully supplied and ... serving two residential towers with an occupancy of 900 ... quarter million gallons per day and was signed on ...
(Date:12/17/2014)... -- Vermillion, Inc. (NASDAQ: VRML ), a bio-analytic ... next step in its expanded strategy to rebuild the ... naming of current Chief Operating Officer, Valerie Palmieri ... Chairman of the Board and CEO James LaFrance ... are effective January 1, 2015. "Jim and ...
(Date:12/15/2014)... METTLER TOLEDO is pleased to announce that the ... PVM technology , is now available. The new ... continuously captures high-resolution images under a wide range ... a report pairing the most relevant images to ... compelling blend of high resolution images and trend ...
(Date:12/15/2014)... COPENHAGEN, Denmark , Dec. 15, 2014 /PRNewswire/ ... its innovative TransCon technology to address significant unmet ... from its ongoing Phase 2 pediatric study to ... growth hormone deficiency, or GHD.  This interim analysis ... the anticipated total enrollment in the study, completing ...
Breaking Biology Technology:Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 2Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 3Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 4New Real-Time In Situ Probe-Based Video Microscope from METTLER TOLEDO 2Ascendis Pharma A/S Announces Positive Six-Month Interim Results from a Phase 2 Pediatric Study of Once-Weekly TransCon Growth Hormone for the Treatment of Growth Hormone Deficiency 2Ascendis Pharma A/S Announces Positive Six-Month Interim Results from a Phase 2 Pediatric Study of Once-Weekly TransCon Growth Hormone for the Treatment of Growth Hormone Deficiency 3Ascendis Pharma A/S Announces Positive Six-Month Interim Results from a Phase 2 Pediatric Study of Once-Weekly TransCon Growth Hormone for the Treatment of Growth Hormone Deficiency 4
... OLDSMAR, Fla., July 10 Cryo-Cell,International, Inc. (OTC ... largest and most established family cord blood banks, ... months ended May 31, 2008., Consolidated revenues ... relatively flat, as compared to approximately $4.5,million for ...
... Today,s Pharmaceutical Research,and Manufacturers of America ... practice,of providing non-educational materials to physicians ... of the physician/industry representative interaction,says Jim ... leading non-profit,organization dedicated to educating and ...
... Robust ... Pipeline -, ... and MacroChem Corporation (OTC Bulletin Board:,MACM) announced today that they had ... the issuance of 2.5,million shares of Access Pharmaceuticals, common stock. MacroChem,s ...
Cached Biology Technology:Cryo-Cell International, Inc. Reports Second Quarter 2008 Results 2Cryo-Cell International, Inc. Reports Second Quarter 2008 Results 3Cryo-Cell International, Inc. Reports Second Quarter 2008 Results 4Cryo-Cell International, Inc. Reports Second Quarter 2008 Results 5Cryo-Cell International, Inc. Reports Second Quarter 2008 Results 6CMR Institute: Education Key to Physician/Representative Relationship 2Access Pharmaceuticals Signs Merger Agreement to Acquire MacroChem Corp. 2Access Pharmaceuticals Signs Merger Agreement to Acquire MacroChem Corp. 3Access Pharmaceuticals Signs Merger Agreement to Acquire MacroChem Corp. 4
... and efficient method for purification of DNA fragments ... fragments selectively absorbed in the spin column after ... room temperature for PCR product with equal volume ... DNA can be purified with a single prep ...
When added to either StemSep CD4+ or CD8+ T Cell Enrichment cocktails, human HLA-DR TAC is designed to deplete human HLA-DR from samples to isolate resting CD4+ or CD8+ T cells....
Fujifilm BAS-1800II provides the ideal configuration for a low-cost imager that requires only a small amount of space in the laboratory. The small imager for accurate high-throughput screening...
Request Info...
Biology Products: