Navigation Links
AMP comments at FDA meeting on next-generation sequencing
Date:6/23/2011

June 23, 2011 (Bethesda, MD): Today, on behalf of the Association for Molecular Pathology (AMP), Dr. Elaine Lyon gave public comments at the US Food and Drug Administration's (FDA) meeting on "Ultra High Throughput Sequencing for Clinical Diagnostic Applications Approaches to Assess Analytical Validity." As they begin developing their program to evaluate sequencing based diagnostics, AMP advised FDA officials on many important considerations for evaluating analytical validity.

The analytical validation requirements for NGS will vary based on the clinical application at issue, such as a mutation panel for a Mendelian disease versus transcriptome analysis. Also, performance of, and coverage needs for, a given platform are likely to differ depending on the nucleic acid analyzed, the characteristics of the DNA regions and the type of variations interrogated, the relative allele proportions of particular variants, and whether quantitative or qualitative results are desired. For these reasons, Dr. Lyon noted "this necessitates flexibility and individualization in the development of validation protocols, guidelines, and controls on an application-by-application basis."

While the analytical validity of a NGS instrument may be intrinsically very high, its data conversion and analysis software may have design flaws or performance limitations. As such, AMP told the FDA that for optimal FDA review of the test system, the analytical validity of the instrument and the performance of the bioinformatics software should be evaluated both independently and as a complete system.

AMP also pointed out the role of molecular pathology professionals in determining the most appropriate platform and technologies for answering the clinical question at issue and advised the FDA to be careful not to limit the practice of medicine. "Optimal patient care requires the ability of molecular pathology professionals to use their professional opinion of the most suitable technological approach," added Dr. Lyon, "and any FDA policy to review analytical validity should include a role for the molecular pathology professionals performing the test."

AMP calls on the FDA to partner with professional associations to benefit from their wealth of experience and expertise on next generation sequencing (NGS) and its clinical applications. "We have an important reservoir of experience and expertise within our organization," explained Dr. Lyon, "and we encourage the FDA to allow us to collaborate to ensure that this technology is safely, effectively, and appropriately used for the benefit of our patients." AMP is also currently working on professional practice guidelines to address the many ethical, social and legal implications for the clinical use of NGS, which will be beneficial for the entire medical community including the FDA.


'/>"/>

Contact: Mary Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

Related biology news :

1. AMP comments at FDA meeting on array-based tests
2. AMP submits comments on SACGHS report
3. Director of Berman Institute comments on FDA Approval of first human embryonic stem cell trial
4. Registration opens for first Middle East and Africa osteoporosis meeting
5. MARC travel award announced for GSA C. elegans meeting
6. Scientists at the Ecological Society of Americas 2011 Annual Meeting to discuss global stewardship
7. Sound research at Acoustical Society meeting
8. MARC Travel awards announced for the Endocrine Societys 93rd Annual Meeting and Expo
9. Presidential keynote address and new research highlights from the American Society of Pediatric Otolaryngology meeting
10. NYU Langone experts present advances at American Association of Neurological Surgeons Meeting
11. NIDCD research at AChemS Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2017)... DUBLIN , Feb 10, 2017 ... PharmaBiotech,s new report "Personalized Medicine - Scientific and Commercial ... ... in personalized medicine. Diagnosis is integrated with therapy for selection ... emphasis on early detection and prevention of disease in modern ...
(Date:2/8/2017)... Inc. (NASDAQ: AWRE ), a leading supplier of ... quarter and year ended December 31, 2016. ... compared to $6.9 million in the same quarter last year. ... million compared to $2.6 million in the fourth quarter of ... $0.5 million, or $0.02 per diluted share, which compares to ...
(Date:2/8/2017)... , Feb. 7, 2017 Report Highlights ... billion by 2021 from $8.3 billion in 2016 at ... 2016 to 2021. Report Includes - An overview ... global market trends, with data from 2015 and 2016, ... 2021. - Segmentation of the market on the basis ...
Breaking Biology News(10 mins):
(Date:2/18/2017)... Research and Markets has announced the addition ... to their offering. ... The report provides separate comprehensive analytics for the US, ... of World. Annual estimates and forecasts are provided for the period ... these markets. Market data and analytics are derived from primary and ...
(Date:2/17/2017)...  Protagonist Therapeutics, Inc. (NASDAQ: PTGX) today presented ... drug candidates, PTG-100 and PTG-200, at the 12 ... Colitis Organization (ECCO).  The ECCO congress is being ... from February 15 – 18, 2017. ... drug candidates PTG-100 and PTG-200. PTG-100, a potential ...
(Date:2/16/2017)... PALM BEACH, Fla. , Feb. 16, 2017 ... diagnostics company revolutionizing the development of liquid biopsy ... it has entered into an exclusive license agreement ... will distribute MDNA,s proprietary liquid biopsy test for ... South Korea . This is ...
(Date:2/16/2017)... BEACH, Florida , February 16, 2017 /PRNewswire/ ... improving with the infusion of innovative telemedicine application, ... monitoring services that are experiencing a boom worldwide. ... with the advancement of technologies, services and new ... Inc. (OTC: RQHTF) (TSX-V: RHT), Cellectar Biosciences, Inc. ...
Breaking Biology Technology: