RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • 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

    Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say

    Experts within FDA's newly established Oncology Center of Excellence (OCE) discussed the office's role in the first site-agnostic cancer treatment approval and programs for further advancing oncology-related regulatory science and policy. And in the concluding section of the article, the OCE experts note that FDA, which has typically approved companion diagnostics under a "one drug, one diagnostic" paradigm, is "likely to" shift to a "many drugs, a panel of diagnos...
  • Regulatory NewsRegulatory News

    Industry Weighs in on FDA Draft Guidance on Infectious Disease NGS-Based Diagnostics

    Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance. "Next generation sequencing has the capability to replace previous methods with a single approach to accomplish what might have required several different tests in the past," FDA explains. "In contrast to human sequencing di...
  • Regulatory NewsRegulatory News

    Two Draft FDA Guidelines on NGS Set Foundation for Precision Medicine Initiative

    New next generation sequencing (NGS) technologies that can examine millions of DNA variants at a time and help inform treatment decisions are at the heart of two new draft guidance documents released Wednesday evening by the US Food and Drug Administration (FDA) as part of President Barack Obama’s Precision Medicine Initiative. FDA says the guidance offers a streamlined approach to the oversight of diagnostics that detect medically important differences in a person’s gen...
  • 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

    Precision Medicine: Technology, Regulations and Challenges

    • 11 March 2016
    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • Feature ArticlesFeature Articles

    Precision Medicine: Technology, Regulations and Challenges

    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • 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 ...