ACLA UPDATE: FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies The FDA said it intends to focus on specific EUA requests, while HHS withdrew a policy directing FDA not to enforce premarket review requirements for LDTs. People in the News: New Appointments at Hologic, Akoya Biosciences, Caris Life Sciences, More New Coalition, Stakeholder Groups Push Back Against FDA 'Backdoor' Attempts to Regulate PGx Tests Premium While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions. ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing. Stakeholders Voice Concerns, Push Back on NCD for NGS Cancer Panels Premium In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion. Mar 27, 2019 CMS to Revisit National Coverage Determination on NGS Tumor Testing Feb 1, 2019 Healthcare Stakeholders Ask CMS Not to Limit Access to NGS Hereditary Cancer Risk Tests Jan 22, 2019 Labs, Advocacy Groups Push Back on Medicare Policy Shift on NGS Testing for Hereditary Cancer Risk Premium Nov 15, 2018 FDA, Industry Willing to Collaborate on Dx Regulation via Legislation Despite Differences Premium Jun 22, 2018 Some Stakeholders Not on Board With Draft Bill on New Dx Regulatory Framework Premium May 4, 2018 FDA Recommends Precertification Program to Legislators as They Consider Dx Regulatory Reform Mar 15, 2018 Industry Groups Lobby Congress Ahead of Final CMS National Coverage Policy on NGS Cancer Panels Premium Feb 15, 2018 ACLA Seeks Summary Judgment in PAMA Lawsuit Jan 5, 2018 Personalized Medicine Continued Growth in 2017 Despite Political, Reimbursement Uncertainty Premium Dec 11, 2017 ACLA Files Lawsuit Challenging PAMA Rates Sep 28, 2017 Lab Industry Fears Consolidation and Further Price Erosion if PAMA Prices Stick Premium Sep 22, 2017 CMS 2018 PAMA Pricing Cut for Lab Tests Deeper Than Prior Estimate; Advanced Dx Lab Tests Fare Well Jun 1, 2017 Lab Group Backs Draft Bill Proposing Dx Regulatory Reform; Finds Points of Agreement With FDA Paper Premium Mar 30, 2017 CMS Will Give Labs More Time to Report PAMA-Required Payor Data Mar 24, 2017 Lab Industry Group Asks CMS to Extend PAMA Implementation Timeline to 2019 Jan 17, 2017 FDA Releases Discussion Paper on LDT Regulation After Gathering Stakeholder Feedback Premium Nov 18, 2016 FDA Holding Off on Finalizing Regulatory Guidance for Lab-Developed Tests Jun 20, 2016 CMS Holding Off Market-Based Payment for Labs Until 2018; Tweaks Criteria for Labs Reporting Pricing Mar 29, 2016 Legislators Urge CMS to Delay PAMA Implementation Jan 28, 2015 Draft of 21st Century Cures Legislation Addresses Device Reforms, but Silent on LDTs Load More Breaking News IndyGeneUS AI Acquires Genetic Cryptocurrency Creator EncrypGen Analysis Estimates Psychiatric Disorder Risk from Specific Copy Number Variants in Danish Cohort Proteomic Profiling With Two Platforms Provides Complementary Gene, Protein, Phenotype Links Centogene Reports 17 Percent Drop in Q3 Revenues, Closing Down COVID Testing Business StageZero Raising C$4.2M in Private Placement of Stocks, Warrants NGeneBio Gets CE-IVD Mark for HLA Typing Assay The Scan Comfort of Home The Guardian reports that AstraZeneca is to run more clinical trials from people's homes with the aim of increasing participant diversity. Keep Under Control Genetic technologies are among the tools suggested to manage invasive species and feral animals in Australia, Newsweek says. Just Make It The New York Times writes that there is increased interest in applying gene synthesis to even more applications. Nucleic Acids Research Papers on OncoDB, mBodyMap, Genomicus In Nucleic Acids Research this week: database to analyze large cancer datasets, human body microbe database, and more.