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

specificity and reproducibility of intra- and inter-laboratory test results."

A major hurdle for laboratories is the reimbursement of diagnostic tests. Escalating costs for test development, performance, interpretation and reporting, compounded with additional costs to satisfy new regulatory requirements could result in the elimination of important clinical tests. In considering revisions to the current oversight processes, AMP urged FDA to realize the potential ramifications on test availability due to economic considerations.

Lastly, AMP recommended that the FDA convene an external advisory committee composed of individuals with expertise in the relevant diagnostic areas to assist in identifying the appropriate risk classifications. Dr. Lyon said, "There is much debate in the community about the criteria used to group LDTs into low, medium and high risk categories. An external advisory committee would be a very valuable tool for the FDA as it works to make these determinations."

Dr. Lyon concluded, "As the FDA considers its approach to regulating LDTs, AMP encourages the agency to consider the unanticipated effects that significant modifications to the current oversight system could represent for clinical laboratories." These unanticipated effects include the possibility that laboratories may be compelled to discontinue services and/or potentially lose flexibility to rapidly introduce and continually improve tests, all of which would adversely impact delivery of effective care to our patients.

In holding this meeting, AMP believes that the FDA has taken an important step forward and AMP looks forward to partnering with the FDA and continuing to work with the Agency for the benefit of patients.


'/>"/>

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:12/17/2014)... 2014 Valencell, a leader in performance biometric ... to industry leaders such as Intel, Jabra, Atlas, and ... wearable products. These products will be showcased at CES ... Vegas . "Our partners choose ... robust – with the clinical data to back it ...
(Date:12/11/2014)... 09, 2014 Research and Markets ... ( http://www.researchandmarkets.com/research/twhjll/biometrics_market ) has announced the addition ... Region 2015-2019"  report to their offering. ... is advances in technology. With continuous advances in ... to the latest standard that meets the needs ...
(Date:12/10/2014)... 8, 2014 You,ve been here before: you desperately ... remember your password, site key or the answer to your ... grade teacher? Today, Hoyos Labs , ... that will finally put an end to the frustration that ... . 1U leverages a user,s smartphone to acquire his ...
Breaking Biology News(10 mins):Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Biometrics Market in the APAC Region 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 3
... 21 September, 2006 - Elsevier is delighted to ... the journal Vaccine: HPV Vaccines and Screening in ... provides a comprehensive and invaluable update for paediatricians, ... major donor institutions worldwide. , With the arrival ...
... is time to protect patients from “vile and cynical exploitation?by ... week’s BMJ. , It is estimated that up to 80% ... follow a dietary programme to help treat their cancer, writes ... , Yet the rationale for the use of many of ...
... used for intestinal research, the colonsope, causes patients great ... developed, inspired by the way in which snails move. ... degree from TU Delft based on this research subject. ... to navigate through with a medical device. Yet, many ...
Cached Biology News:Protect patients from exploitation by alternative medicines industry 2Like a snail through the intestinal canal 2
(Date:12/19/2014)... Reports from CDC show ... from one or more chronic health conditions - including ... address some of these diseases, but may not eliminate ... face. While implanted nerve stimulation devices today offer relief, ... which can induce side effects. , To eliminate ...
(Date:12/19/2014)... CA (PRWEB) December 18, 2014 With ... limited time special on Sartorius Biohit products . ... on mLINE pipettes, Picus Electronic Pipette Trade-in Program, and ... Health and Safety officers around the world. They are ... pipetting. Other features include:, ,     Full volume ...
(Date:12/19/2014)... Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage ... pain, announced the results of its annual general meeting ... transformational year in Relmada,s history and it set the ... Sergio Traversa , chief executive officer of Relmada. ... financial, human resource and clinical development objectives that position ...
(Date:12/17/2014)... 2014 Achim Noack has been named ... Group. In this position, Noack will assist Jerry Stoller, ... develop marketing strategy and supervise global marketing management and ... has tremendous knowledge and experience in the crop protection ... experience and innovative thinking will be a great asset ...
Breaking Biology Technology:Draper Wins GSK Funding for Smaller, Smarter Implantable Devices 2Major Pipette Distributor Pipette.com Announces Sartorius Year End Specials 2Relmada Therapeutics Announces Results of Annual Shareholders Meeting 2Achim Noack Joins Stoller Group as Global Vice President of Marketing and Administration 2
... - Saying his higher education initiatives would increase the ... Jim Doyle has urged lawmakers to advance his ... has proposed the direct spending of $225 million to ... capabilities, and recruit more faculty members. The Legislature ...
... that patents and publications used to uphold a challenge to ... proliferation of human embryonic stem cells, the Wisconsin Alumni ... an initial determination by the U.S. Patent and Trademark ... Gulbrandsen, managing director of WARF, were supported by Dr. ...
... Madison, Wis. - Peter Logothetis pondered the ... concluded that it's part of a natural - and ... meet corporate objectives, to building strong working relationships with ... the business as well as information technology, the position ...
Cached Biology Technology:WARF questions relevancy of documents used to uphold patent challenge 2WARF questions relevancy of documents used to uphold patent challenge 3CIO Leadership Series: Logothetis likes CIO's evolving role 2CIO Leadership Series: Logothetis likes CIO's evolving role 3CIO Leadership Series: Logothetis likes CIO's evolving role 4CIO Leadership Series: Logothetis likes CIO's evolving role 5
... CLS number is a ... to easily match Cornings ... no availability yet, please ... Sigma-Aldrich number (Z71,448-8) or ...
This CLS number is a new product number, created to easily match Cornings product number. If showing no availability yet, please order under the old Sigma-Aldrich number (E6027) or contact customer s...
... This high pressure gradient system ... piston pumps, each providing a flow rate in ... dual wavelength detector for added flexibility. System ... data processing software and interface unit, CE 4900., ...
... of large numbers of samples may be carried ... minimum operator attention. System control and data ... CE 4900. The elegant, powerful and very ... and Windows 98 and 2000., The supplied detector ...
Biology Products: