RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    MDIC Works to Standardize Oversight of NGS-based Assays

    To advance the regulatory science of diagnostic testing and assay development, the Medical Device Innovation Consortium (MDIC) posted a new landscape analysis report Wednesday to provide a snapshot of all known projects related to next-generation-sequencing (NGS) oncology reference samples.   The landscape analysis report serves as a catalog of information on 35 projects marked as either completed, ongoing or under development. Projects were divided into five categorie...
  • Regulatory NewsRegulatory News

    CDRH Looks Ahead to Priorities for 2018 to 2022

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it has met its three strategic goals from 2016 and 2017 and it has outlined three more for 2018 to 2022. Looking ahead to these next three years, CDRH Director Jeff Shuren pointed to three priorities: Better engage the center’s employees and decrease turnover rates, streamline and modernize at least 80% of the center’s processes, and establish new ...
  • Regulatory NewsRegulatory News

    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
  • Regulatory NewsRegulatory News

    For Developers of New Genome Sequencing Analytical Tools, FDA Launches ‘App-a-Thon’

    The US Food and Drug Administration (FDA) on Monday launched what it’s calling an “App-a-Thon,” inviting software developers to get together and add next-generation sequencing (NGS) software apps to the precisionFDA app library. The challenge, which closes 28 October 2016, is looking to engage the NGS community in the development of new genome sequencing analytical tools for use on precisionFDA, which is an online research portal for NGS assay evaluation and regul...
  • Regulatory NewsRegulatory News

    FDA Issues Draft Guidance on NGS Sequencing for Infectious Disease Diagnostics

    The US Food and Drug Administration (FDA) on Thursday issued new draft guidance meant to establish the necessary performance characteristics for genetic sequencing tests used to diagnose infectious diseases. Due to the complexity of these tests, FDA is proposing to regulate them as complete systems that encompass all processes from specimen collection through obtaining clinical results. NGS Tests for Infectious Disease In recent years, FDA has been working to develop i...
  • Regulatory NewsRegulatory News

    FDA Discusses How to Regulate NGS Tests for Cancer Diagnoses

    The US Food and Drug Administration (FDA) is seeking input on how to regulate next-generation sequencing (NGS) tests that can scan a tumor's genes to guide cancer treatments. At a public workshop at FDA's campus in Silver Spring, MD on Thursday, experts in oncology and NGS discussed some of the challenges and considerations for establishing standards for validating what's known as NGS-based oncology panels or assays. In recent years, increased understanding of genetics ...
  • Regulatory NewsRegulatory News

    precisionFDA Launches to Help With NGS Assay Validation, Data Sharing

    In the spirit of sharing, the US Food and Drug Administration (FDA) on Tuesday launched precisionFDA, a new online, cloud-based platform where genomics experts from industry, academia, government and elsewhere can come together and securely share data on next-generation sequencing (NGS). The beta-launch of the site opens the door for accessing and sharing datasets, analysis pipelines, bioinformatics tools and other approaches that also could advance regulatory science. ...
  • Regulatory NewsRegulatory News

    FDA Officials Review Algorithms Used for NGS Analysis

    A group of scientists from the US Food and Drug Administration's (FDA) Division of Bioinformatics and Biostatistics have reviewed the algorithms used to align the data generated by next-generation sequencing (NGS) tests to reference genomes. NGS tests hold great promise for precision medicine due to their ability to quickly sequence the human genome and identify thousands of genetic variants. By identifying genetic variants that are associated with different diseases, r...
  • Regulatory NewsRegulatory News

    NGS Altering the Landscape of Antiviral Drug Resistance Analysis, FDA Officials Say

    As next-generation sequencing (NGS) costs gradually decline, the Food and Drug Administration’s (FDA) Division of Antiviral Products (DAVP) anticipates that more companies will make the switch to NGS for future antiviral drug resistance analyses and other additional uses. The push to more NGS use comes as DAVP independently assessed NGS resistance data for three new drug applications (NDAs), which taught the agency a few important lessons and will help it prepare for the...
  • Regulatory NewsRegulatory News

    FDA Looks to Curate Genetic Databases to Support NGS Validation

    Experts met at the US Food and Drug Administration (FDA) today to discuss how curated databases could be used to establish the clinical relevance of genetic variations, and how the agency could use these databases to evaluate next-generation sequencing (NGS) diagnostics. NGS tests have the ability to quickly sequence the human genome and identify thousands of genetic variants. However, as Erin Ramos of the National Human Genome Research Institute put it, our "ability to ...
  • Regulatory NewsRegulatory News

    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
  • Regulatory NewsRegulatory News

    FDA Looks to Develop Regulatory Strategies for Genomic Testing

    To further the president's Precision Medicine Initiative (PMI), the US Food and Drug Administration (FDA) is working to develop regulatory systems for diagnostics using next generation sequencing (NGS) technologies. Background Since 2014, FDA has sought input from the public on how it could develop a regulatory system appropriate for reviewing and regulating NGS technologies. The agency says it believes such a system "could potentially be applied to many other types o...