LDTs Artemis DNA to Provide Datar Cancer Genetics Liquid Biopsy Tests in the US, Vietnam Under $250M Deal Under the five-year exclusive agreement, Artemis DNA will offer Datar Cancer Genetics' Trucheck Pragma and Cancertrack tests in the US and Vietnam. Guardant Health Confident in New CRC Screening Blood Test Despite Competitor Skepticism Premium Having officially launched its Shield colorectal cancer screening assay as an LDT, Guardant stands to benefit from a head start in clinical establishment. Genetron Health Q4 Revenues Up 10 Percent The company's IVD sales revenue rose significantly, offsetting a quarter-over-quarter drop in revenue from in-house LDT serves. ACMG Survey Finds Laboratory Geneticists Have Concerns Over Proposed Changes to LDT Regulation Lab geneticists are raising concerns as the US Congress is expected to take up a bill that would change how the Food and Drug Administration oversees LDTs. Precipio Hematologic Malignancy Test Receives NY State Approval The Hemescreen test uses proprietary high resolution melt technology and can now be used in labs in New York as a laboratory developed test. Nov 15, 2021 FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies Nov 9, 2021 Invitae Unveils Plans to Expand Cancer Testing Portfolio Premium Oct 11, 2021 EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access Premium Sep 21, 2021 Phosphorus Wins Conditional New York State Approval for GeneCompass Consumer Test Aug 5, 2021 NYU Langone Health, Philips Integrate Informatics for FDA-Cleared Cancer Sequencing Panel Premium Feb 25, 2021 Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch Premium Nov 17, 2020 NanoString Technologies, OHSU Partner on Breast Cancer Spatial Protein Profiling Assay Development 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 Load More Breaking News Becton Dickinson Gets CE-IVD Mark for High-Throughput COVID/Flu PCR Test QuantuMDx Obtains CE Mark for 30-Minute Multiplex Respiratory Panel Mitochondrial Protein Resource Reveals New Disease Players StageZero Life Sciences, DiagnoseAtHome Partner on Multicancer Blood Test OraSure Technologies Selected by HHS to Provide COVID-19 School Testing Hologic Obtains CE Mark for Molecular Epstein-Barr, BK Virus Assays The Scan UK Moves to Allow Sale of Gene-Edited Food The UK is moving ahead to allow the sale of gene-edited food in England, Scotland, and Wales, according to New Scientist. Questions for the Field Stat News writes that the alleged Buffalo shooter's citation of genetics research raises questions about what the field can do. Cell Studies on Tumor Evolution in Mouse Model of Lung Cancer, Stereo-seq, Bacteriophage Responses In Cell this week: tumor evolution tracked in mouse model of lung cancer, organogenesis mapped using Stereo-seq, and more. Taking Stock of the Stockpile The US and European countries are evaluating their smallpox vaccine stockpiles as the number of monkeypox cases increases, the Washington Post reports.