ACLA 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 Guardant Health Files Motions to Dismiss, Change Venue in Illumina Patent Lawsuit In Brief This Week: SQI Diagnostics, T2 Biosystems, Enhanc3D, QuidelOrtho, More Illumina, Precision Health Research Singapore Partner for 100K Genomes Population Study 23andMe Fiscal Q4 Revenues Increase 14 Percent Local Coverage Determinations Roundup: Castle Bio, SkylineDx Ancient Genome Sequence Provides Look at Ancestry for Individual Who Perished at Pompeii The Scan Billion-Dollar Diversity Initiative The Howard Hughes Medical Institute is now accepting applications for its new $1.5 billion initiative to boost the diversity of the scientific workforce. Biotech Co-Founder Arrested A co-founder of a Los Angeles-based biotech company has been arrested in connection with a murder-for-hire scheme, according to Endpoint News. Return of the Tasmanian Tiger The Washington Post reports that a team in Australia is working to bring the thylacine back from extinction. Nature Papers on Genome of Individual From Pompeii, CircRNA Study Best Practices, More In Nature this week: first sequenced genome of a person from Pompeii, best practice guidelines for circRNA studies, and more.