LDTs EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access Premium The EC has stuck with its timeline to implement the new regulations in eight months, raising concerns for cancer patients' ability to receive biomarker testing and treatments. Phosphorus Wins Conditional New York State Approval for GeneCompass Consumer Test The firm's health screening sequencing assay, which retails at $249 and covers a panel of over 400 genes, will now be available to consumers in all 50 states. NYU Langone Health, Philips Integrate Informatics for FDA-Cleared Cancer Sequencing Panel Premium Philips has automated the informatics pipeline for NYU Langone's pan-cancer LDT and integrated its Genomics Workspace software with the health system's Epic EMR. Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch Premium Adaptive Cofounder and Chief Scientific Officer Harlan Robins compared the launch of the test to the unveiling of the Tesla Roadster electric sports car. NanoString Technologies, OHSU Partner on Breast Cancer Spatial Protein Profiling Assay Development A new GeoMx Digital Spatial Profiler assay will have up to 30 protein targets and will be validated for potential use as a laboratory-developed test. Sep 10, 2020 FDA Joins PGx Collaborative Community but Effect on Field is Unclear Premium Aug 28, 2020 Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs Premium Aug 20, 2020 HHS Says FDA Can't Regulate Lab-Developed Tests Without Notice, Comment Rulemaking Mar 17, 2020 Fulgent Genetics, MedScan Laboratory Partner to Offer NGS Coronavirus Test Mar 16, 2020 Coronavirus Testing Delays Yield New Oversight Bill, Shine Light on LDT Regulation Debate Mar 5, 2020 FDA Defends Actions Against PGx Testing Labs As Necessary to Protect Public Health Premium Jan 13, 2020 Adaptive Biotechnologies, Genentech Partner on MRD Testing in Venetoclax Clinical Trial Jan 10, 2020 Coalition Files Citizen Petition to Stop 'Unlawful' FDA Actions Against PGx Testing Nov 8, 2019 Illumina, Lexent Partner on NGS-Based Cancer IVD Kit Oct 11, 2019 New Coalition, Stakeholder Groups Push Back Against FDA 'Backdoor' Attempts to Regulate PGx Tests Premium May 30, 2019 Columbia University Medical Center NGS Cancer Panel Receives New York State Conditional Approval Apr 15, 2019 Inova Decides to End PGx Test Offerings in Response to FDA Warning Letter Apr 10, 2019 FDA Warning Letter to Inova Raises Questions About Agency Overreach Into Practice of Medicine Premium Dec 10, 2018 Legislators Release New Draft Bill Incorporating FDA Ideas for Diagnostics Regulation Nov 15, 2018 FDA, Industry Willing to Collaborate on Dx Regulation via Legislation Despite Differences Premium Aug 8, 2018 FDA Details Vision for Regulating In Vitro Clinical Tests to Legislators Jun 22, 2018 Some Stakeholders Not on Board With Draft Bill on New Dx Regulatory Framework Premium Jun 18, 2018 MDx Systems Integrate LDTs With IVD Kits for Labs Seeking Greater Efficiency Premium Jan 5, 2018 Personalized Medicine Continued Growth in 2017 Despite Political, Reimbursement Uncertainty Premium Dec 8, 2017 Evogen Presents on Protein Markers for Epilepsy Dx Premium Load More Breaking News SUPER Psychosis Study Presented at ASHG Digs Into Relationships of Rare Variants, Phenotypes People in the News: New Appointments at Myriad Genetics, Becton Dickinson, Delfi Diagnostics, More In Brief This Week: Virginia Commonwealth University, Dovetail Genomics, Lucid Diagnostics, and More New Products Posted to GenomeWeb: Bio-Rad, PerkinElmer, Ares Genetics, Purigen Biosystems, More Genetron Health, Fosun Ink Commercialization Deal for Seq-MRD Test in China MultiMuTHER Team Tracks Expression, Metabolite Relationships in Aging TwinsUK Participants The Scan More Boosters for US Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes. From a Pig A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports. For Privacy's Sake Wired reports that more US states are passing genetic privacy laws. Science Paper on How Poaching Drove Evolution in African Elephants In Science this week: poaching has led to the rapid evolution of tuskless African elephants.