> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Appreciation for FDA Next-gen Sequencing Guidances
- URL: https://www.fdaweb.com/appreciation-for-fda-next-gen-sequencing-guidances/
- Published: 2016-10-19T12:00:00.000Z
- Updated: 2026-09-14T21:40:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137117

The Biotechnology Innovation Organization (BIO) says it welcomes the release of two FDA draft guidances on regulating next generation sequencing (NGS) tests. [Commenting](https://www.regulations.gov/document?D=FDA-2016-D-1233-0018&ref=fdaweb.com) specifically on the guidance dealing with use of public human genetic variant databases to support clinical validity for next generation sequencing-based *in vitro* diagnostics, BIO says the guidances demonstrate “FDA’s strong commitment to be forward thinking in its approach to establish a regulatory framework that permits continued innovation in personalized medicine products and tools that improve the lives of patients.” The association says it appreciates the agency’s recognition that the current regulatory pathways are not well suited to assess NGS technology and will create further challenges as the pace of development continues to accelerate. Before offering specific comments, BIO notes that the two draft guidances issued 7/8 avoid mention of the overarching debate about agency oversight of laboratory-developed tests. “BIO believes that it is important to address outstanding regulatory issues in concert,” the letter says. “BIO recommends that the agency strive to publish the final guidance documents on a laboratory-developed test regulatory framework, co-development of companion diagnostics, and next generation sequencing as close to unison as possible.”

In its [comments](https://www.regulations.gov/document?D=FDA-2016-D-1233-0007&ref=fdaweb.com), Roche says it appreciates the “innovative and flexible regulatory framework” FDA outlined for the regulation of NGS devices. It recommends that the approach of using public human genetic variant databases to support clinical validity for NGS-based tests be applied to other *in vitro* diagnostic technologies. And it says that the draft guidance should more clearly recognize that proprietary databases, in addition to public databases, may be used to support clinical validity for NGS-based tests. Finally, Roche calls on FDA to include in the guidance specific details on certain aspects such as sponsor and database administrator requirements for database changes, the recommended standard database format, and the nomenclature for gene names and/or symbols.

In its general [comments](https://www.regulations.gov/document?D=FDA-2016-D-1233-0019&ref=fdaweb.com), AdvaMedDx commends FDA for setting forth in the draft guidance a “highly innovative and flexible approach on evidence generation for *in vitro* technologies while recognizing the critical importance that tests have adequate clinical performance.” It says that such adaptive approaches “will go far to promote scientific progress and robust innovation by diagnostic developers of NGS-based assays as well as other revolutionary tests that are moving high quality precision medicine into the U.S. healthcare system.” It recommends that the agency extend the wider application of the proposed approach to support the clinical validity of other diagnostic tests. It also says that all efforts should be made to ensure equitable application of the approach for all interested developers, whether laboratory or traditional *in vitro* diagnostic manufacturers, from test development and modification through the product lifecycle. “While that appears to be the intent of FDA,” the letter says, “any final approach should be clear that it is not limited by type of developer. We also recommend that the guidance more clearly recognize that databases may be proprietary or public and clarify which portions of the guidance would apply to proprietary databases.” The group also provides specific line-by-line comments.

Support for using both public and proprietary databases also is voiced by the law firm Hogan Lovells in its comment [letter](https://www.regulations.gov/document?D=FDA-2016-D-1233-0019&ref=fdaweb.com). “FDA should be applauded for proposing an innovative and efficient approach to developing clinical validity evidence via public databases,” it says. “At the same time, to fully realize the power of this practical approach, the definition of public database should not be limited to open access databases only. Rather, the approach should be applicable also to commercial databases. Such databases are sustainable, well-maintained, and of high quality, which provide additional valuable data to supplement the open access databases.”

Finally, the Association of Molecular Pathology (AMP) [says](https://www.regulations.gov/document?D=FDA-2016-D-1233-0030&ref=fdaweb.com) that “there is a need to modernize FDA’s approach to the regulation of *in vitro* diagnostic test kits that are manufactured and sold to laboratories. This includes development of more consistent and predictable regulatory pathways, with reasonable requirements that are appropriate to the context in which a test is generally used.” Commenting on the use of databases, AMP says that the interpretation of a laboratory test remains within the practice of medicine and while databases aid in the interpretation of a test result, no database can or should replace the professional interpretation provided by molecular professionals. It also says that professional societies should establish criteria for evaluating database quality.