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)... Feb 10, 2017 Research and ... "Personalized Medicine - Scientific and Commercial Aspects" to ... ... Diagnosis is integrated with therapy for selection of treatment as ... detection and prevention of disease in modern medicine. Biochip/microarray technologies ...
(Date:2/8/2017)... Feb. 7, 2017 The biometrics market ... the confluence of organizations, desires to better authenticate ... systems (password and challenge questions), biometrics is quickly ... systems. The market is driven by use cases, ... consumer and enterprise uses cases, with consumer-facing use ...
(Date:2/6/2017)... 2017 According to Acuity Market Intelligence, ... authorities to continue to embrace biometric and digital ... Automated Border Control (ABC) eGates and 1436 Automated ... than 163 ports of entry across the globe. ... a combined CAGR of 37%. APC Kiosks reached ...
Breaking Biology News(10 mins):
(Date:2/22/2017)... Dublin - Research and Markets has announced ... Type, By Application, By End User, By Region, By Country: Opportunities ... ... is forecasted to grow at a CAGR of 11.33% during 2016-2021. ... protection market is driven by the surging demand for less toxic ...
(Date:2/22/2017)... -- Aethlon Medical, Inc. (Nasdaq: AEMD ), ... the ability of the Aethlon Hemopurifier® to capture latent ... immune-suppressed sepsis patients and also contribute to organ rejection ... the study was to validate the in vitro ... Herpes Simplex virus 1 (HSV1) by the Hemopurifier®. The ...
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... ... announced the addition of Tom Perkins as European director. Operating from Pennside’s Zurich ... to Pennside. , Perkins joins Pennside after more than a decade with ...
(Date:2/22/2017)... N.C., Feb. 22, 2017  United Therapeutics Corporation (NASDAQ: ... results for the fourth quarter and year ended ... results reflect continued growth as net revenues reached ... Martine Rothblatt, Ph.D., United Therapeutics, Chairman and Chief ... to develop and advance our growing product pipeline, ...
Breaking Biology Technology: