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LDTs

EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access
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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
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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
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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
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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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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
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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
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Jun 18, 2018

MDx Systems Integrate LDTs With IVD Kits for Labs Seeking Greater Efficiency
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Jan 5, 2018

Personalized Medicine Continued Growth in 2017 Despite Political, Reimbursement Uncertainty
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Dec 8, 2017

Evogen Presents on Protein Markers for Epilepsy Dx
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Breaking News
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.