LDTs 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. FDA Joins PGx Collaborative Community but Effect on Field is Unclear Premium The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate. Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs Premium The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health. HHS Says FDA Can't Regulate Lab-Developed Tests Without Notice, Comment Rulemaking The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review. 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 Nov 10, 2017 Despite Q3 Slump, Genomic Health Confident Tests Will Hold Ground Against Competitors Premium Oct 12, 2017 At FDA/AACR Liquid Biopsy Meeting, Researchers Detail Concordance Challenges, Standards Premium Jul 11, 2017 Controversial Gum Disease Risk Test Highlights Precision Medicine Marketing, Regulatory Issues 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.