ACLA 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. CMS to Revisit National Coverage Determination on NGS Tumor Testing CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients. Healthcare Stakeholders Ask CMS Not to Limit Access to NGS Hereditary Cancer Risk Tests The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy. 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 Jan 15, 2015 Q&A: ACLA Lawyers Clement, Tribe Discuss FDA's Legal Problem in Regulating LDTs Premium Jan 15, 2015 Q&A: Lawyer John Conley Counters Lab Industry Arguments against FDA Regulatory Authority over LDTs Premium Load More Breaking News Bruker Posts 34 Percent Jump in Q2 Revenues GenomeWeb Index Gains Slightly in July as Fluidigm, PerkinElmer, Bio-Rad Post Strong Increases Feinstein Institutes for Medical Research Wins $2.9M NIH Grant to Study Polygenic Embryo Screening Top Five Articles on GenomeWeb Last Week: CDC, Bio-Rad, 10x Genomics, PerkinElmer, and More InterVenn Biosciences Closes $201M Series C Round Abcam to Acquire Life Science Research Tool Firm BioVision for $340M The Scan And Back The New York Times reports that missing SARS-CoV-2 genome sequences are back in a different database. Lacks Family Hires Attorney A lawyer for the family of Henrietta Lacks plans to seek compensation from pharmaceutical companies that have used her cancer cells in product development, the Baltimore Sun reports. For the Unknown The Associated Press reports that family members are calling on the US military to use new DNA analysis techniques to identify unknown sailors and Marines who were on the USS Arizona. PLOS Papers on Congenital Heart Disease, COVID-19 Infection Host MicroRNAs, Multiple Malformation Mutations In PLOS this week: new genes linked to congenital heart disease, microRNAs with altered expression in COVID-19, and more.