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:4/2/2015)... 2, 2015 Fingerprint Cards (FPC) ... FPC1025 from the distributor World Peace Industrial Group (WPI), ... 2015 although the major part of the shipments will ... used by smartphone manufacturers in China ... in the communicated revenue guidance of + 1 000 MSEK ...
(Date:3/31/2015)... March 31, 2015   Guidepoint , a leading ... the Post-Surgical Pain Management TRACKER, part of the ... trends in the medical device and therapeutics markets. The ... including treatment volumes, market share, and adoption rates across ... with joint surgery. The Post-Surgical Pain Management ...
(Date:3/24/2015)... 24, 2015 Research and Markets ( http://www.researchandmarkets.com/research/kvdtcw/face_and_voice ) ... - Global Strategic Business Report" report to their offering. ... Biometrics in US$ Thousands by the following Segments: Face Biometrics, and ... Canada , Japan , ... Middle East & Africa , and ...
Breaking Biology News(10 mins):Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 110 Million 2Guidepoint Launches Post-Surgical Pain Management TRACKER 2Guidepoint Launches Post-Surgical Pain Management TRACKER 3Face and Voice Biometrics - Global Strategic Business Report 2015: Face Recognition Gains Prominence in Immigration Control 2Face and Voice Biometrics - Global Strategic Business Report 2015: Face Recognition Gains Prominence in Immigration Control 3Face and Voice Biometrics - Global Strategic Business Report 2015: Face Recognition Gains Prominence in Immigration Control 4Face and Voice Biometrics - Global Strategic Business Report 2015: Face Recognition Gains Prominence in Immigration Control 5Face and Voice Biometrics - Global Strategic Business Report 2015: Face Recognition Gains Prominence in Immigration Control 6
... environs to take up residence in a large and ... University Bloomington scientists report in this week's Science that ... , "Plants that reproduce clonally or are capable of ... the nucleus," said graduate student Yaniv Brandvain, lead author ...
... and give a short-term boost to cognitive skills, a University ... Professor Ian Macdonald found that consumption of a cocoa drink ... blood flow to key areas of the brain for two ... areas of the brain may help to increase performance in ...
... Dentistry (NYUCD) research team has found the first oral bacterial ... Africa to Asia. , The team, led by ... NYUCD, discovered that Streptoccocus mutans, a bacterium associated with dental ... clear line that can be traced back to a single ...
Cached Biology News:Mitochondrial genes move to the nucleus -- but it's not for the sex 2Boosting brain power -- with chocolate 2'Ancestral eve' was mother of all tooth decay 2
(Date:4/24/2015)... 2015  Navitas Life Sciences is delighted to announce the ... and Regulatory Services. Shalabh is a proven leader in Life ... of Kinapse, as well as a Strategy consultant at Accenture. ... http://photos.prnewswire.com/prnh/20150423/201261LOGO ... am delighted to welcome Shalabh into this critical role and ...
(Date:4/23/2015)... April 24, 2015 Ralco announced today ... Birthright Nutrition® (ABN) for the exclusive worldwide rights to ... new technology is a new in-line milk system that ... allowing them to move supplementation milk cups within a ... , “This technology lets producers get Birthright™ milk to ...
(Date:4/23/2015)... 2015 /CNW/ - A new and innovative service has ... North America,s largest packaging trade ... in the "Sustainability, service" category of the PAC ... Comparison" is a service that scores clients, packaging ... peers. This benchmarking process shows clients how their ...
(Date:4/23/2015)... April 23, 2015  Neurocrine Biosciences, Inc. (Nasdaq: ... its first quarter 2015 results before the Nasdaq market ... host a live conference call and webcast to discuss its ... April 30, 2015 at 8:00 a.m. Eastern Time (5:00 ... live conference call by dialing 866-952-1906 (US) or 785-424-1825 ...
Breaking Biology Technology:Shalabh Kumar Joins Navitas Life Sciences to Lead their Clinical and Regulatory Services Teams 2Ralco Acquires License to Birthright™ Moveable Milk Cup 2Neurocrine Biosciences Announces Conference Call and Webcast to Report First Quarter 2015 Results 2
... Richard Duffey, M.D., to its LASIK Directory. ... also serves patients from Pensacola, Florida and from ... Mississippi.,Trusted LASIK Surgeons launched its revolutionary Trusted LASIK ... consumers at www.TrustedLASIKSurgeons.com . What sets the ...
... Varian, Inc.,(NasdaqGS: VARI) introduced its new dual wavelength ... proteins. The SuperNova(TM) is the,first dual wavelength diffraction ... It includes innovations in both X-ray,technology and data ... crystals., Single crystal X-ray diffraction is used ...
... Quality and process,improvement efforts gained new momentum ... higher efficiencies fueled by a stagnating economy.,Biopharmaceutical companies ... pipelines are affecting the bottom line, competition for ... brought more scrutiny to R&D,and New Product Development ...
Cached Biology Technology:Trusted LASIK Surgeons Welcomes Mobile Alabama Expert Refractive Eye Surgeon Richard Duffey, M.D. to Its LASIK Directory For Consumers 2Trusted LASIK Surgeons Welcomes Mobile Alabama Expert Refractive Eye Surgeon Richard Duffey, M.D. to Its LASIK Directory For Consumers 3Trusted LASIK Surgeons Welcomes Mobile Alabama Expert Refractive Eye Surgeon Richard Duffey, M.D. to Its LASIK Directory For Consumers 4Trusted LASIK Surgeons Welcomes Mobile Alabama Expert Refractive Eye Surgeon Richard Duffey, M.D. to Its LASIK Directory For Consumers 5Trusted LASIK Surgeons Welcomes Mobile Alabama Expert Refractive Eye Surgeon Richard Duffey, M.D. to Its LASIK Directory For Consumers 6New Dual Wavelength X-ray Diffractometer From Oxford Diffraction, Now a Part of Varian, Inc., Allows Increased Throughput for Challenging Single Crystal Analyses 2Leading Biopharmas Will Deliver Case Studies on Achieving Productivity Excellence through Engagement, Technology, Other Tools 2
... This product has been developed to significantly ... labeled proteins. Stability is increased at ... 2-8 centigrade. This product is subjected ... mercury or azide. This formulation insures ...
...
These 25x25 square No.1 Corning cover glasses are made from No. 0211 zinc titania glass and are 0.16 to 0.19mm thick. • Approx. Pcs Oz : 102...
... Bead Separation is a powerful tool for ... Typical applications are DNA/RNA or protein purification ... has been fully automated on the Genesis ... Te-MagS. ,In combination with the RoMa ...
Biology Products: