LDTs

May 9, 2022

Artemis DNA to Provide Datar Cancer Genetics Liquid Biopsy Tests in the US, Vietnam Under $250M Deal

May 9, 2022

Guardant Health Confident in New CRC Screening Blood Test Despite Competitor Skepticism
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Mar 29, 2022

Genetron Health Q4 Revenues Up 10 Percent

Mar 25, 2022

ACMG Survey Finds Laboratory Geneticists Have Concerns Over Proposed Changes to LDT Regulation

Dec 21, 2021

EU Adopts Amendment for IVD Regulation Transition

Nov 23, 2021

FDA, HHS Guidance on COVID-19 LDTs Draws Mixed Reactions from Industry Stakeholders
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Nov 18, 2021

Precipio Hematologic Malignancy Test Receives NY State Approval

Nov 15, 2021

FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies

Nov 9, 2021

Invitae Unveils Plans to Expand Cancer Testing Portfolio
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Oct 25, 2021

As EU Proposes Phased Implementation of IVDR, Observers Caution Challenges Remain
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Oct 11, 2021

EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access
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Oct 7, 2021

Europe IVD Regulation Will Heavily Impact Use of Laboratory-Developed Tests, Experts Say
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Sep 28, 2021

20/20 GeneSystems Accelerator Program Allows International Dx Companies to Build US Business
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Sep 21, 2021

Phosphorus Wins Conditional New York State Approval for GeneCompass Consumer Test

Aug 4, 2021

Immunovia Receives Massachusetts Approval to Begin Testing of Patients for Pancreatic Cancer

Jun 4, 2021

European Authorities Face Growing Calls to Postpone New IVD Regulation
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May 19, 2021

Rand Paul Reintroduces Bill Aimed at Blocking FDA Regulation of LDTs

Feb 25, 2021

Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch
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Nov 17, 2020

NanoString Technologies, OHSU Partner on Breast Cancer Spatial Protein Profiling Assay Development

Nov 12, 2020

Laboratory Stakeholders Weigh In On Biden Administration Priorities