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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
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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
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Oct 11, 2021

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

Sep 10, 2020

FDA Joins PGx Collaborative Community but Effect on Field is Unclear
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Aug 28, 2020

Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs
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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
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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
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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
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Breaking News
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.